Industrial Cell Culture Product Catalog...TECHNICAL SERvICE Technical assistance is available to answer your questions regarding all Irvine Scientific products. We also provide Material

©2009 Irvine Scientific P/N 40536 Rev.7

Irvine Scientific2511 Daimler Street, Santa Ana, CA 92705-5588Phone: 1 800 437 5706 · Fax: 1 949 261 6522www.irvinesci.com

Irvine Scientific - IrelandUnit 31, Newtown Business & Enterprise Park Newtownmountkennedy · Co. Wicklow · IrelandPhone: +353 1 281 99 20 · Fax: +353 1 281 99 28

Industrial Cell Culture Product Catalog

www.irvinesci.com

Cytogenetics and Diagnostic ProductsHeadline for TOC

Headline for TOC

Contents

CONTENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 Domestic and International Ordering . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 Pricing and Terms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 Lot Reservation Policy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 Quotations and Method of Payments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 Technical Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 Shipping, Cancellations and Returns . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 Conditions and Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 Global Presence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

CELL CULTURE PRODUCTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Custom Media Progam . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 Prototype Media Progam . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 Serum-Free Media . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 Classical Media . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 Salt Solutions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 Protein Hydrolysates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20 Water for Injection (WFI) Grade Water . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21 Reagents and Media Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22 Cell Culture Sera . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24 Mycotrim® TC Screening for Cell Culture . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25 Flexible Packaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26

TECHNICAL INFORMATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30 Antibiotics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

INDEX . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38

General Information

1 (800) 437-5706 • 1 (949) 261-7800



General InformationIntroduction

INTRODUCTION TO IRvINE SCIENTIFICIrvine Scientific was established in May 1970 in Fountain Valley, California to produce serum products for the cell culture market. In the fall of 1973, Irvine Scientific reorganized and emerged as a respected entity for cell culture products on the west coast. In the years to follow, Irvine Scientific extended its products, services and operations to become multi-disciplined and international in scope. By the fall of 1977, Irvine Scientific had outgrown its Fountain Valley facility and relocated to its present site in Santa Ana, CA.

In August 1987, a Japanese-based firm, Japan Energy Company (JEC, formerly Nippon Mining Company), acquired an 80% interest in Irvine Scientific. JEC brought new capital to Irvine Scientific and a stated goal to become a leader in the expanding biopharmaceutical field. JEC became the sole shareholder in July 1996. Their solid support has enabled Irvine Scientific to provide its products worldwide to manufacturers of diagnostic and pharmaceutical products, as well as the cytogenetic, reproductive and clinical laboratories.

Today, Irvine Scientific is a diversified company. Irvine Scientific sells products in a variety of markets, including industrial cell culture media, sera products, media for the cytogenetics laboratory as well as a complete product line for assisted reproductive technology. In the late 1980’s Irvine Scientific further expanded and acquired the serum-free cell culture and diagnostic product lines from Hana Biologics, Inc. Most recently, Irvine Scientific has emphasized its manufacturing capabilities for custom media formulations. Irvine Scientific’s efforts are directed toward continued growth of its products and the markets it serves.

QUALITY POLICYIrvine Scientific will strive to be the top performer for our clients across all business units and build relationships of trust with our customers.

We will estabilish, review and communicate our quality objectives throughout our orginization, assure understanding of our objectives, and review our policy to assure its continuing suitability.

Our quality management system will conform to all applicable requirements.

MISSIONIrvine Scientific’s mission is to set the standard for EXCELLENCE through:

• QualityProductsfortheCellCulture,Diagnostics,and Biopharmaceutical Markets• QualityServicewithrespect,courtesy,andloyaltytoourcustomers• QualityPeoplededicatedtocompletecustomersatisfaction• Customersatisfactionisnotourgoal…itisourpolicy!

IRvINE SCIENTIFIC CORPORATE CULTURE MISSIONIn keeping with our commitment of quality, we expect every team member to demonstrate integrity and accountability to one’s self, our colleagues and the business of Irvine Scientific.

We are committed to mutual respect, honesty and leadership by example. Irvine Scientific requires a strong work ethic and open communication at every level.

Integrity: Doing the right thing, in the right way for the right reasonswithout compromise.

Accountability: Owning your responsibilities, actions and the results of your actions, whether good or bad, as individuals and collectively as team members.

Mutual Respect: Showing consideration for one another and appreciation of each other’s contributions to the company.

Honesty: Being truthful.

Leadership by Example: Ensuring that the expectations you have of others are reflected in your own actions.

Work Ethic: Being self-motivated to commit one’s full effort each workday. Workasthoughyouownpartofthecompany!

Open Communications: Speaking candidly, expressing true opinions, and listening effectively throughout all levels of the organization.

2

www.irvinesci.com


Headline for TOC

IntroductionGeneral Information

QUALITY SYSTEMSWe take pride in the fact that our quality systems are second to none by offering:

•Outstandingvalidationsprograms

•Strongtechnicalsupportforcustomers

•Documentationandtraceabilityforallmanufacturedlots

•Unsurpassedregulatorystrength

•Consistentlyexpedientresponsetocustomers

•Excellenttrackrecordforauditsandinspections

•Corporateculturefocusonvaluesandcustomers

ISO 13485 CERTIFICATIONIrvine Scientific has received Certification to the ISO 13485 International Quality Standard. The Certification was achieved after completing anassessment of the quality management system against the comprehensive requirements of the world-class standard to the manufacture of medical devices.

This certification illustrates the commitment of Irvine Scientific to providing quality products to the industrial, research, and laboratory biomedical communities worldwide. More than 90 countries belong to ISO, the International Standards Organization. Many of these countries, including theUnitedStates,thecountriesoftheEuropeanUnion,Japan,CanadaandAustralia, have been working together to harmonize standards governing product registration.The ISO13485QualityStandardhas served as thefoundation for harmonization. Irvine Scientific is pleased to have successfully developed a quality management system that meets rigorous standards and focuses on meeting the expectations of the customers we serve.

FDA CLEARANCEWhererequired,ourproductshavebeenclearedbytheFDAincomplianceto510Ks.DrugMasterFilesforourkeyproductshavebeenfiledwiththeFDAtofurtherassisttheregulatoryneedsofourcustomers.

INTERNATIONAL COMPLIANCEOur products are manufactured to meet Harmonized Standards, where applicable, throughout our manufacturing and quality control process.

CE MARKINGOur products meet European requirements for CE Marking.

3

1 (800) 437-5706 • 1 (949) 261-7800



ORDERINGTelephone, fax, online and mail orders are accepted. Please includea purchase order number and your telephone number on all orders. Confirming purchase orders are NOT required on telephone orders. If a confirming purchase order must be sent, be sure it is clearly marked —“CONFIRMATION,DONOTDUPLICATE”.

Placeordersforitemsinthiscatalogwith:

Irvine Scientific Attention:CustomerServiceDepartment 2511DaimlerStreet SantaAna,CA92705-5588U.S.A.

INTERNATIONAL ORDERSAllinternationalordersmustbepre-paidpriortoshipment.PaymentmustbemadeinU.S.FundsdrawnonaU.S.Bankorbydirectwiretransferto:

MellonBank,Pittsburgh,PA Reference ABA #043000261

and indicate: for credit to Merrill Lynch Account #1011730 for further credit to Irvine Scientific Sales Co., Inc. Account#224-04244.SwiftMELNUS3P

Please add $20 to your wire transfer amount to cover bank fees. Anadditional export documentation fee will be added to orders shipped outside oftheUnitedStates.

ToplaceInternationalorders: Phone 001-949-261-7800 Fax 001-949-261-6522

PRICING AND TERMSIrvine Scientific reserves the right to change prices without notice. Any price reduction will automatically apply to your invoice. Invoices are due in net 30daysinU.S.dollars.Afinancechargeof1.5percentpermonth(annualpercentage rate of 18 percent) will be charged to past due accounts.

LOT RESERvATION POLICYSamples will be provided at no charge for the purpose of testing a particular lot. Reserved lots will be held for three weeks from the date the sample is shipped. Upon completion of your testing, a purchase order for the amount reserved is required to secure product. The reserve will be automatically cancelled at the end of the three weeks unless otherwise notified.

CREDIT CARD ORDERSFor your convenience Irvine Scientific accepts VISA®, MasterCard® and American Express® as payment for your order. Please provide yourcredit card account number and expiration date when you place your order.

SPECIAL QUOTATIONSQuantity discounts are available on standing orders. Products can be bulk-packaged in custom sized containers at specially quoted prices.

TECHNICAL SERvICETechnical assistance is available to answer your questions regarding all Irvine Scientific products. We also provide Material Safety Data Sheets(MSDS) and Certificates of Analysis (CofA). Call 1 (800) 437-5706 for all technical inquiries.

PERISHABLE PRODUCT PACKAGINGPerishableproductswillbepackedasappropriate in insulatedcartons forsafe arrival. A packaging charge will be added as a separate item on our invoice when products require dry ice or cold packaging. We will not accept responsibility for shipments packaged contrary to our procedures at the customer’s request.

General Information Domestic and International Ordering

United States HeadquartersCorporate Offices 1 (800) 437-5706 Phone 1(949)261-7800 Fax 1 (949) 261-6522E-mail [email protected] www.irvinesci.com

European HeadquartersPhone 3531281-99-20Fax 353 1 281-99-28E-mail [email protected]

4

www.irvinesci.com


Headline for TOC

General Information Shipping

SHIPPINGItemsorderedareshippedwithin48hoursofreceiptoftheorder.Partialshipments may be made when complete orders cannot be shipped. If partial shipments are not acceptable, indication should be made at the time the order is placed.

Orders are shipped via best way unless otherwise specified. To avoid possible damage when shipments are made near a weekend or holiday, we ship frozen or cold packaged products on Monday, Tuesday, or Wednesday. We will not accept responsibility for shipments made contrary to our normal shipping schedule. Special shipping requirements must be clearly indicated at the time an order is placed.

Shipments are FOB origin, freight prepaid. Title to the items sold passes to the purchaser upon delivery of the items to the carrier.

SHORTAGES AND DAMAGESIf a shortage occurs in any shipment received from Irvine Scientific, please notify our Customer Service Department within three business days fora credit or replacement product. Otherwise, the order will be considered complete.

Irvine Scientific provides assistance with filing claims for loss or damaged product.Pleasekeepallpackingmaterialsandcontainersforinspectionbythe carrier.

CANCELLATIONSCancellation of custom prepared products will not be accepted after manufacturing has begun.

RETURNSA Return Goods Authorization number and shipping instructions must be obtained fromourCustomer ServiceDepartment prior to returning anyproduct. All product must be returned in good condition and is subject to a handling and restocking charge of 20 percent plus freight. No product may be returned after 30 days.

Where spoilage occurs in transit, please advise Customer Service and request instructions immediately upon receipt of the shipment. Credit will not be issued on any items that are returned without prior authorization.

CONDITIONSUnless otherwise indicated, the products listed herein are for purposesdescribed only. They are not to be used for administration to humans or for drug purposes. Nothing disclosed herein is to be construed as a recommendation to use products in violation of any patents. The information presented is believed to be accurate. However, said information and products are offered without warranty or guarantee since the ultimate conditions of use and the variability of the materials treated are beyond our control. We cannot be responsible for patent infringements or other violations that may occur with the use of these products.

The information presented in this catalog concerning product specifications, descriptions, price, returns, and conditions is effective the date the catalog is printed and supersedes all previous publications. Please visit ourwebsite, www.irvinesci.com, for up-to-date information, including media formulation charts.

INTENDED USEUnless otherwise indicated, the products listed herein arefor in vitro diagnostic use or research use only. Not for drug use. Consult labeling.REDUCE•RE-USE•RECYCLE

Irvine Scientific is concerned with the environmental impact of our packaging materials and we encourage our customers to dispose of these materials responsibly.Effectivere-useandrecyclingofthesecomponentsdependsonyou.Pleaseusethefollowingguidelinestohelpusprotectourenvironmentfor future generations:

Packaging Material Re-use Recycle Glass-Type 1 Borosilicate Auroclave or expose to Not currently recyclable dry heat (121°C for 15 min 15 psi)

Plastic-PET DisinfectwithSodiumHypochlorite Disinfectedbottlescanberecycledwith (bleach)orquaternaryammonium consumerPET base.3xrinsewithDIwater. Incineration(resultsinCO₂+H₂O)

Plastic-PETG DisinfectwithSodiumHypochlorite Disinfectedbottlescanberecycledwith (bleach)orquaternaryammonium consumerPET(sodabottles) base.3xrinsewithDIwater. Incineration(resultsinCO₂+H₂O)

Plastic-HDPE Disinfect Disinfectedbottlescanberecycledwith consumerHDPE

Bubblewrap-PE PackagingMaterial LocalRecyclingCenter

PolystyreneFoam(EPS) MailBoxes,Etc. RecycleEPS CFC Free Recycle Hot Line 1(800) 944-8448 for the nearest collection site

5

1 (800) 437-5706 • 1 (949) 261-7800


General InformationShipping

Irvine Scientific’s Global Presence

ARGENTINAAUSTRALIAAUSTRIABAHRAINBANGLADESHBELGIUMBOLIVIABRAZILCANADACHILECHINACOLOMBIACOSTARICACYPRUSCZECHREPUBLICDENMARKDOMINICAN REPUBLIC ECUADOR EGYPT ESTONIA FINLAND FRANCE GERMANYGREECEGUAMGUATEMALAGUYANAHONDURASHONGKONGHUNGARYICELANDINDIAINDONESIAIRELANDISRAELITALYJAMAICAJAPANJORDANKOREAKUWAITLATVIALEBANONLIBYALITHUANIALUXEMBOURGMALAYSIAMEXICONETHERLANDSNEWZEALANDNIGERIANORWAYPANAMAPARAGUAYPERUPHILIPPINESPOLANDPORTUGAL PUERTORICO RUSSIA SAUDIARABIA SINGAPORE SOUTHAFRICA SPAINSWEDENSWITZERLANDTAIWANTHAILANDTURKEYU.A.E.UKRAINEUNITEDKINGDOMUNITEDSTATESURUGUAYVENEZUELA

For the local distributor of Irvine Scientific products in your country,pleasecontactourUSACustomerServiceDepartmentorvisitourwebsite:www.irvinesci.comPhone:001-949-261-7800Fax: 001-949-261-6522

6

www.irvinesci.com


7

Cell Culture ProductsContents

Custom Media Progam . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

Prototype Media Progam . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

Serum-Free Media . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

Classical Media . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

Salt Solutions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

Protein Hydrolysates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

Water for Injection (WFI) Grade Water . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

Reagents and Media Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

Cell Culture Sera . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

Mycotrim® TC Screening for Cell Culture . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

Flexible Packaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26

1 (800) 437-5706 • 1 (949) 261-7800


8

Cell Culture ProductsCell Culture Media

Media Formulas reflect Irvine Scientific’S active support of the Society for In Vitro Biology (SIVB, formerly the Tissue Culture Association) standards committee to standardize media formulations. Media and other cell culture products are prepared to comply with the standard committee recommendations when available and applicable, or to conform with published formula. Extensive literature references are available to enable the user to trace the sources and changes of all components of formulas used by Irvine Scientific.Unpublished improvements or correctionsmade by theoriginal author or a principal user are available when known. When such changes vary from the original beyond the limits established by the SIVB committee, Irvine Scientific assigns a new catalog number and modifies the description to clearly reflect that change. Authors and users are requested to communicate such corrections to our technical personnel.

Powdered Cell Culture Media and Balanced Salts are prepared in accordance with the original formula for liquid when feasible. Anhydrous salts are substituted on an equimolar basis. All powders are vacuum dried beforemilling.Powdersarepackedinscrewcappedcontainersandshouldbe stored dry according to product labeling. Small aliquots may be removed for use if appropriate concern formoisture is exercised.Powderedmediais checked for particle size uniformity and complete solubility. Irvine Scientific uses special procedures to achieve thorough distribution of trace compounds in powdered media.

Quality Assurance is carefully maintained. Irvine Scientific facilities and procedures are subject to inspection by the Federal Food and DrugAdministration andCaliforniaDepartmentofHealthServices.Weoperate our facility under the guidelines specified by the Current Good Manufacturing Practices (cGMP’s) for Medical Devices and ISO 9001InternationalQuality Standard. Inspection of our facilities is available toqualified customers by appointment.

Chemicals used in Irvine Scientific Cell Culture products conform to at least ACS, USP, or NF standards when available. Certificates of Analysis are obtained from manufacturers or vendors. Samples of components are tested for endotoxin, identity, efficacy and toxicity as appropriate.

Water is processed onsite by a state-of-the-art WFI system. The system is validated according to FDA, PDA and USP 24 guidelines for water for injection. The water system is routinely monitored for microbial levels, endotoxin, pH, conductivity and resistivity and total organic carbon (TOC) levels.

Sterility testing of all media are done in accordance with Code of Federal Regulations (CFR) Title 21, Part 610.12 or United StatesPharmacopeia (USP) 25. Random samples are filtered through 0.45micron membranes. The membranes are incubated at 30°-35°C in fluid thioglycollate and at 20°-25°C in soybean-casein digest media and observed regularly for 14 days.

Growth Promoting Characteristics of media are tested in parallel with control media on appropriate cell lines for a minimum of three serial passages. Rate of growth, cell density, morphology, and evidence of toxicity or cytopathic effects are observed throughout testing. All products must meet rigid standards of performance prior to release.

Endotoxin is measured using the LAL gel clot or kinetic chromogenic methodology.Productscontainingproteinareheattreatedinboilingwaterfor 2 minutes to denature the enzymes that interfere with the enzyme cascade reaction for endotoxin detection. (Associates of Cape Cod – LAL Methodology Workshop, 10/94)

pH is measured at a 1X concentration in accordance with finished product specifications. Due to the constraints imposed duringmanufacturing, 10X and powdered media may require some adjustment when diluted or dissolved for filtration. The user is reminded that a medium in free exchange with CO₂ in an incubator may establish a final pH different from the initial pH. With pH-sensitive cells, the user should always check aliquots of the final media with a meter as visual estimation can be deceptive.

25 mM HEPESisusedinHEPESbufferedmediatomaximizebufferingcapacity while minimizing toxicity. The osmolality is adjusted by appropriate reduction of sodium chloride. Sodium Bicarbonate is included in 1X liquid media when specified. It is omitted from all powders. Required amounts of sodium bicarbonate are provided in the product description for powdered or liquid media.

L-Glutamine is heat labile and therefore is stored frozen and added fresh just prior to use. Irvine Scientific generally omits L-Glutamine from liquid media to allow the investigator control of this variable. However, selected media are available with L-Glutamine. All but selected powdered media contain L-Glutamine. Required amounts of L-Glutamine are provided in the product description. L-Glutamine may precipitate upon freezing and thawing but redissolves with slight warming and agitation.

Packaging - Liquids are routinely packaged in 100 mL, 500 mL and 1000mLplasticPETbottles.2000mLbottlingisavailableuponrequest. 10 and 20 L bags are standard packaging for selected media. 50, 100, 200, and500Lbags are also available for any liquid. Powderedmedia are instandard packages of 5, 10, and 50 L sizes. Custom packaging is available upon request.

PleasecontactyourIrvineScientifictechnicalsalesrepresentativeforspecialorders.

www.irvinesci.com


9

Cell Culture ProductsMedia Programs

Custom Media Program

THE IRvINE SCIENTIFIC DIFFERENCEAt Irvine Scientific our Custom Media Program is specific to yourunique cell culture requirements, with communication being an essential factor every step of the way. Our ongoing personal service and technical support ensures that your questions and concerns are addressed during the order process, manufacturing and even after your product is received. Our organization is structured to provide customer accessibility to our key team members, and effective communication among all our internal departments.

EXCEEDING YOUR QUALITY EXPECTATIONSOur stringent supplier qualifications and material inspections assure a final product that exceeds all quality requirements. We achieve lot-to-lot consistency through highly detailed manufacturing procedures, precise tolerances on all measures, and strict in-process acceptance ranges. Our facility was one of the first in the country to receive ISO 13485 certification.

COLLABORATE WITH OUR EXPERTSOur research and development team focuses on serum-free media for industrial applications with an emphasis on producing therapeutics. Our team offers these flexible service options:• Designingamediumtomatchyourcustomrequirements• Optimizingyourexistingmediumtoimproveresults• Extendingyourexistingproprietarymediumintolarge-scaleproduction

WHAT YOU CAN EXPECT• Flexibilityofformulaownership• 4-6weeksfordeliveryofproduct• State-of-the-artWFIgradewatersystem• Consistencyinsmallandlargebatches• Packagingoptionsforliquidandpowderform• WorldClasscGMPmanufacturingfacility• Liquid and powder manufacturing capacities to satisfy your large-scale production

For more information about your specific volume and packaging requirements, please contact your local Territory Manager at 1 (949) 261-7800 or (800) 437-5706.

Prototype Media Program

At Irvine Scientific, we understand our Industrial Cell Culture customer’s need for small volume lots to further research and development. Our Prototype Media Program is designed to produce small volume R&Dquality lots within 1-2 weeks, one of the fastest turn-around times in the industry.

QUALITY CONTROLLimited QC testing can be provided by customer request including pH, osmolality and endotoxin. Additional testing is also available upon request.

RAW MATERIALSThe raw materials used in the Prototype Media Program are the samematerials used in Irvine Scientific’s cGMPmanufacturing facility. Thesecomponents have passed strict in-process controls and stringent raw material qualifications.

PERSONAL ATTENTIONIrvine Scientific links your prototype request to our experts in Industrial Cell Culture. Our responsiveness and attention to each request sets us apart from the competition. We welcome the opportunity to design a new culture medium that meets your specific requirements or optimize an existing medium to achieve improved performance.

For more information about your specific volume and packaging requirements, please contact your local Territory Manager at 1 (949) 261-7800 or 1 (800) 437-5706.

1 (800) 437-5706 • 1 (949) 261-7800


10

Cell Culture ProductsSerum-Free Media

Catalog Number Description Size

IS CHO™ contains bovine-derived components and features rapid adaptation from serum-containing media.

91109 ISCHO™LIQUIDSERUM-FREEMEDIUM 1000mL Storage: 2° to 8°C

IS CHO-V™ has been formulated without animal-derived components.

94101 ISCHO-V™POWDERSERUM-FREEMEDIUM 10L Storage: 2° to 8°C

9197 ISCHO-V™LIQUIDSERUM-FREEMEDIUM 1000mL Storage: 2° to 8°C

ISCHO-CD™isachemically-definedformulathatcontainsnoanimal-derivedcomponentsorhydrolysates.Improvedperformanceforconsistency,regulatory requirements, and downstream processing.

94111 ISCHO-CD™POWDERCHEMICALLY-DEFINEDMEDIUM 10L Storage: 2° to 8°C

91119 ISCHO-CD™LIQUIDCHEMICALLY-DEFINEDMEDIUM 1000mL Storage: 2° to 8°C

ISCHO-CD4™isachemicallydefinedformulathatcontainsnoanimal-derivedcomponentsorhydrolysates. 94104 ISCHO-CD4™POWDERCHEMICALLY-DEFINEDMEDIUM 10L Storage: 2° to 8°C

91100 ISCHO-CD4™LIQUIDCHEMICALLY-DEFINEDMEDIUM 1000mL Storage: 2° to 8°C

ISCHOFEED-CDisananimal-componentfreeandchemically-definedfeedmediasupplementdesignedtoenhancecellgrowthperformancebyreplenishing nutrients required to extend the life of CHO cell cultures. This product is specifically formulated with low salt concentrations to minimize the effects of high osmolality.

91108 ISCHOFEED-CD™ 500mL,Liquid Storage: 2° to 8°C

IS CHO MEDIASerum-free growth media designed for long term, high density growth of CHO cells and high expression levels of recombinant proteins. All products come without L-glutamine, hypoxanthine, or thymidine.

www.irvinesci.com


11



ISCHO-CDXP™isthecorecomponentoftheISCHO-CDXP™CultureSystem.Itisagrowthmediumthatsupportsexcellentcellgrowthandproduction of recombinant CHO cell lines.

91120 ISCHO-CDXP™LIQUIDCHEMICALLY-DEFINEDMEDIUM 1000mL Storage: 2° to 8°C

94110 ISCHO-CDXP™PowderChemically-DefinedMedium 10L,powder Storage: 2° to 8°C

ISCHO-CDXP™WithHydrolysateBlendXP™containstheHydrolysateBlendXP™forconvenience.

91121 ISCHO-CDXP™WITHHYDROLYSATEBLENDXP™LIQUIDMEDIUM 1000mL Storage: 2° to 8°C

94113 ISCHO-CDXP™WITHHYDROLYSATEBLENDXP™POWDERMEDIUM 10L,powder Storage: 2° to 8°C

ISCHOFEED-CDXP™isafeedsupplementmatchedtothegrowthmedium.

91122 ISCHOFEED-CDXP™LIQUIDFEEDSUPPLEMENT 500mL Storage: 2° to 8°C

94114 ISCHOFEED-CDXP™POWDERFEEDSUPPLEMENT 5L,powder Storage: 2° to 8°C

ISHydrolysateBlendXP™isanultra-filteredhydrolysatesupplementthatcanbeaddedtothegrowthand/orfeedmedia.

94109 ISHYDROLYSATEBLENDXP™ 10gm,powder Storage: 15° to 30°C

IS CHO-CD XP™ Culture SystemISCHO-CDXP™CultureSystemiscomprisedofagrowthmedium(ISCHO-CDXP™),afeedmedium(ISCHOFEED-CDXP™),andahydrolysatesupplement(ISHydrolysateBlendXP™).Thecomponentsareserum-freeandanimal-componentfree.Whenusedwithouthydrolysatesthecomponentsare also chemically-defined. The system components can be used individually or in various combinations according to the needs of specific CHO culture processes. The kit contains a set of the most commonly used medium configurations.

1 (800) 437-5706 • 1 (949) 261-7800


12



91101 IS293LIQUIDSERUM-FREEMEDIUM 1000mL Storage: 2° to 8°C

91107 IS293-V™LIQUIDSERUM-FREEMEDIUM 1000mL requires supplementation with Iron Chelate* (cat# 9343) @ 1mL/L Storage: 2° to 8°C

*Available at no charge with purchase of medium

HEK-293 / ADENOvIRUS MEDIAIS 293 serum-free medium is optimized for the culture of HEK-293 cells for the production of adenovirus or recombinant proteins. This medium can also be used for growth of HeLa cells, myelomas, hybridomas, and human breast carcinoma cells. All products come without L-glutamine.

www.irvinesci.com


13



9194 ISBAC™LIQUIDSERUM-FREEMEDIUM 1000mL Storage: 2° to 8°C


91104 ISMAB-CD™LIQUIDCHEMICALLY-DEFINEDMEDIUM 1000mL chemically-defined formula contains no animal-derived components or hydrolysates protein-free without L-glutamine Storage: 2° to 8°C

91105 IS GRO®LIQUIDSERUM-FREEMEDIUM 1000mL without L-glutamine Storage: 2° to 8°C

91103 ISPRO®LIQUIDSERUM-FREEMEDIUM 1000mL without L-glutamine Storage: 2° to 8°C

9343 IRON CHELATE 20 mL *Available at no charge with purchase of medium use 1 mL per liter of medium Storage: 2° to 8°C

INSECT CELL CULTURE MEDIAIS BAC™ is a serum-free and protein-free medium which supports the growth of Spodoptera frugiperda (Sf 9 and Sf 21) and Trichoplusia ni (BTI-TN-5B1-4 or High Five™ cells) for the production of recombinant proteins using the Baculovirus Expression Vector System (BEVS).

HYBRIDOMA MEDIAThese serum-free media were designed for the growth of hybridoma cells and the production of monoclonal antibodies. IS MAB-V™ is free of animal-derived components;contains5mg/Lproteintomaintainhighdensityculturesofhybridomacells.ISMABCD™isachemically-definedmediumformulatedwithcomponents of non-animal origin designated to address customer concerns relating to consistency, regulatory requirements and downstream processing. ISGRO™contains50mg/Lproteintopromoterapidadaptationandgrowthofhybridomacells.ISPRO™promotesgrowthandmonoclonalantibodyproduction at a low protein concentration (1 mg/L).

1 (800) 437-5706 • 1 (949) 261-7800



T151 HB 101®LIQUIDKIT 1Lkit and each liquid kit consists of T151 (1 ea) and T000 (2 ea) T000 T T151 - HB 101®LYOPHILIZEDSUPPLEMENT 10mL T000-HBBASALLIQUID 500mL Storage: 2° to 8°C

T151 HB 101®POWDERKIT 10Lkit and each powder kit consists of T151 (10 ea) and T007 (1 ea) T007 T T151 - HB 101®LYOPHILIZEDSUPPLEMENT 10mL T007-HBBASALPOWDER 10L Storage: 2° to 8°

T shipped with dry ice

HB 101®

Designedtosupportthegrowthofmurineandhumanhybridomas,myelomas,lymphoblastoidcells,SP2/0hybrids,P3hybrids,someNS-1cellslines,endothelialcellsandmurinecellhybrids.Proteinconcentrationapproximately780µg/mL.

14


www.irvinesci.com


15

Cell Culture ProductsClassical Media


9195 CLICK’SMEDIUM(EHAAMEDIUM) 500mL with 1350 mg/L sodium bicarbonate without Mercaptoethanol without L-glutamine, add 20 mL/L (200 mM) Storage: 2° to 8°C


9024 DMEHIGHGLUCOSEWITHOUTL-GLUTAMINE 500mL with 4500 mg/L glucose 1000 mL with 3700 mg/L sodium bicarbonate without sodium pyruvate without L-glutamine, add 20 mL/L (200 mM) Storage: 2° to 8°C

9031 DMEHIGHGLUCOSE 500mL with L-glutamine 1000 mL with 4500 mg/L glucose with 3700 mg/L sodium bicarbonate without sodium pyruvate Storage: 2° to 8°C

9041 DEFICIENTDMEHIGHGLUCOSE 500mL with 4500 mg/L glucose with 3700 mg/L sodium bicarbonate without sodium pyruvate without phenol red without L-glutamine, add 20 mL/L (200 mM) Storage: 2° to 8°C

DME DULBECCO’S MODIFICATION OF EAGLE’S BASAL MEDIUM (BME)Withafourfoldincreaseinaminoacidsandvitamins,alongwithadditionalnutrients,DMEprovidessupportforgrowthofawidevarietyofcelllines.Originally used for embryonic mouse and virally infected hamster cells.

CLICK’S MEDIUM (EHAA MEDIUM)

1 (800) 437-5706 • 1 (949) 261-7800


IMDM ISCOvE’S MODIFIED DULBECCO’S MEDIUM AmodificationofDulbecco’sBMEusinghighglucoseandpyruvate,additionalaminoacids,25mMHEPES,seleniumandothercomponents.Designedfor serum free growth of primary hemopoietic cells in culture. Additionally supports the growth of lymphocytes, hybridomas and a variety of hybrid cells.

McCOY’S MEDIUM 5A (Iwakata and Grace Modification) A general medium for primary and established cell lines using increased glucose, additional vitamins, high phosphate and peptone.



9058 HAM’S F-12 500 mL with 1176 mg/L sodium bicarbonate without L-glutamine, add 5 mL/L (200 mM) without linoleic acid Storage: 2° to 8°C

9052 HAM’SF-12/DMEHIGHGLUCOSE1:1MIXTURE 500mL with 3151 mg/L glucose 1000 mL with 1200 mg/L sodium bicarbonate without L-glutamine, add 12.5 mL/L (200 mM) without linoleic acid Storage: 2° to 8°C

9077 HAM’SF-12K(KAIGHN’SNUTRIENTMIXTUREF-12) 500mL with 2500 mg/L sodium bicarbonate 1000 mL without ascorbic and linoleic acids without L-glutamine, add 10 mL/L (200 mM) Storage: 2° to 8°C


9032 ISCOVE’SMODIFIEDDULBECCO’SMEDIUM 500mL with25mMHEPESbuffer 1000mL with 3024 mg/L sodium bicarbonate without alpha-thioglycerol without L-glutamine, add 20 mL/L (200 mM) Storage: 2° to 8°C


9090 McCOY’SMEDIUM5A 500mL with 3000 mg/L glucose with 2200 mg/L sodium bicarbonate without L-glutamine, add 7.51 mL/L (200 mM) Storage: 2° to 8°C

HAM’S NUTRIENT MIXTUREOriginallydevelopedforcloningChineseHamsterOvaryandlungcells.Useful,withserumsupplements,foravarietyofserumfreeapplicationsincluding the growth of myeloma and hybridoma cells.

16

www.irvinesci.com


Catalog Number Description Size 9126 MEM 1X EARLE’S SALTS 500 mL with 2200 mg/L sodium bicarbonate 1000 mL without non-essential amino acids without L-glutamine, add 10 mL/L (200 mM) Storage: 2° to 8°C

9130 MEM NEAA 1X EARLE’S SALTS 500 mL with 2200 mg/L sodium bicarbonate with non-essential amino acids without L-glutamine, add 10 mL/L (200 mM) Storage: 2° to 8°C


9144 ALPHAMEMEARLE’SSALTS 100mL with 2200 mg/L sodium bicarbonate 500 mL with deoxyribonucleosides with ribonucleosides without L-glutamine, add 10 mL/L (200 mM) Storage: 2° to 8°C

9142 ALPHAMEMEARLE’SSALTSWITHOUTNUCLEOSIDES 100mL with 2200 mg/L sodium bicarbonate 500 mL without nucleosides without L-glutamine, add 10 mL/L (200 mM) Storage: 2° to 8°C

ALPHA MEM MEDIUM A Modified Eagle’s Minimum Essential Medium supplemented with amino acids, vitamins, and nucleosides. Designedforgrowthofamouse-hamsterhybridomacellline,8-A(Stannersetal,1971).

MEM EAGLE’S MINIMUM ESSENTIAL MEDIUMAn uncomplicated medium useful for a wide range of species and cells.


17

1 (800) 437-5706 • 1 (949) 261-7800


18



9160 RPMIMEDIUM1640 100mL with 2000 mg/L sodium bicarbonate 500 mL without L-glutamine, add 10.3 mL/L (200 mM) 1000 mL Storage: 2° to 8°C

9161 RPMIMEDIUM1640W/L-GLUTAMINE 100mL with 2000 mg/L sodium bicarbonate 500 mL Storage: 2° to 8°C 1000 mL

9159 RPMIMEDIUM16401XHEPES* 100mL with25mMHEPESbuffer 500mL without L-glutamine, add 10.3 mL/L (200 mM) *Osmolality modified, see formulation Storage: 2° to 8°C

9157 RPMIMEDIUM16401XHEPES*W/L-GLUTAMINE 500mL with25mMHEPESbuffer *Osmolality modified, see formulation Storage: 2° to 8°C

RPMI MEDIUM 1640Designedforgrowthofhumanleukemiacellsineithermonolayersorsuspensionandusefulforawidevarietyofsuspensionandmonolayerculturesandfor hybridomas.

www.irvinesci.com


19

Cell Culture ProductsSalt Solutions

HBSS - HANKS’ BALANCED SALT SOLUTION


9220 HBSS1X-HANKS’BALANCEDSALTSOLUTION 100mL with calcium and magnesium salts 500 mL with phenol red with sodium bicarbonate Storage: 15° to 30°C

9228 HBSS1X-HANKS’BALANCEDSALTSOLUTION 100mL with phenol red 500 mL with sodium bicarbonate without calcium and magnesium salts Storage: 15° to 30°C

9230 HBSS10X-HANKS’BALANCEDSALTSOLUTION 500mL with phenol red without calcium and magnesium salts without sodium bicarbonate Storage: 15° to 30°C

PBS - DULBECCO’S PHOSPHATE BUFFERED SALINE SOLUTION


9236 PBS1X-DULBECCO’SPHOSPHATEBUFFERED 500mL SALINESOLUTION 1000mL with calcium and magnesium salts without phenol red without sodium bicarbonate Storage: 15° to 30°C

9240 PBS1X-DULBECCO’SPHOSPHATEBUFFERED 100mL SALINESOLUTION 500mL without calcium and magnesium salts 1000 mL without phenol red without sodium bicarbonate Storage: 15° to 30°C

9242 PBS10X-DULBECCO’SPHOSPHATEBUFFERED 500mL SALINESOLUTION without calcium and magnesium salts without phenol red without sodium bicarbonate Storage: 15° to 30°C

9281 POTASSIUMCHLORIDESOLUTION0.075N 100mL 5.59 g potassium chloride/liter of water 500 mL Storage: 15° to 30°C

1 (800) 437-5706 • 1 (949) 261-7800


20

Cell Culture ProductsProtein Hydrolysates

PROTEIN HYDROLYSATESProteinhydrolysateshavelongbeenusedinserum-freecellculturemediaassupplementstoimprovegrowthorproduction.Thesehydrolysatesarespecificallydesigned for cell culture applications where low endotoxin levels and high clarity are required. All contain pure sources of soluble amino acids, peptides, vitamins and essential elements. Incoming raw material testing and specifications for these products have been carefully designed to ensure consistency. Growth testing is performed using CHO cells to ensure superior performance.


96850 OPTIMIZEDHYDROLYSATEMIXTUREFORCHOCELLS 1kg

96857 ULTRAFILTEREDSOYHYDROLYSATE 1kg

96863 ULTRAFILTEREDYEASTHYDROLYSATE 1kg

www.irvinesci.com


21

Cell Culture ProductsWater for Injection (WFI) Grade Water

WATER FOR INJECTION (WFI) GRADE SYSTEMCell culture performance is highly dependent on water purity. Irvine Scientific’s proprietary, state-of-the-art WFI system incorporates a pre-treatment system,avaporcompressionstill,andaWFIdistributionloop.WatertreatmentstepsincludeKDFfiltrationforchlorineremoval,hardnessremovalby theprimary softening system, ahigh intensityUV light bank for chlorine/chloraminesdestruction, a polisher cation exchange system for the removalof ammonia, and a MECO® vapor compression pharmaceutical distillation unit for chemical and microbial purification. We continuously monitor for microbiallevels,endotoxin,conductivity,pH,andTotalOrganicCarbon(TOC).OurWFIsystemproducesfinishedwaterthatexceedsUSPguidelines as well as stringent new European standards.

WFI System PerformanceParameter USPstandard ISAvgperformancepH 5.0-7.0 5.49 ± 0.13Bioburden 10 cfu/100mL 0 cfu/100mLEndotoxin <0.25EU/mL <0.05EU/mLTOC < 500 ppb 50.8 ± 21.3 ppbConductivity <2.1µS/cm <0.71±0.13µS/cm

IrvineScientificoffersWFIgradewaterin1Land10Lcarboyswitha1-yearshelflife,20Lcarboys2-yearshelflife.OurWFIgradewatermeetsQCtesting requirements up to the expiration date. This includes TOC which is guaranteed to be < 500 ppb at time of fill and at time of expiration.


9309 WATERFORINJECTION(WFI)GRADEWATER* 1L suitable for cell culture, in vitro diagnostic 20 LC and further manufacturing use meetsUSPcriteriaforpackagedWFI Storage: 15° to 30°C *WFIGRADEWATERmaynotbesoldforuseinreproductiveproceduresorA.R.T.purposes.Notforparenteraluse.

1 (800) 437-5706 • 1 (949) 261-7800



22

Cell Culture ProductsReagents and Media Components

CELL CULTURE REAGENTS


9304 NON-ESSENTIALAMINOACIDS100X 100mL for MEM (Minimum Essential Medium - Eagle) Storage: 2° to 8°C

9317 L-GLUTAMINESOLUTION 100mL T 29.2 mg/mL (200 mM) 500 mL in normal saline Storage: below -10°C

9319 HEPESBUFFERSOLUTION1M 100mL 238.3 g/L in water Storage: 2° to 8°C

LIQUID ANTIBIOTICS


9355 GENTAMICINSULFATESOLUTION 20mL 50 mg/mL gentamicin (base) in water recommend: 1 mL/L medium Storage: 15° to 30°C.

www.irvinesci.com


23

Cell Culture ProductsReagents and Media Components

1Trypsin1:250(PorcineParvovirusTested)1gramwilldigest250grams of Casein under N.F. test for Casein digestive power in pancreatinT shipped with dry ice

ENZYMES


9314 EDTASOLUTION0.526mM (versene solution 1:5000) 100 mL 0.2g/LEDTAtetrasodiumsalt phosphate buffered saline solution without calcium and magnesium salts without phenol red Storage: 15° to 30°C

9336 TRYPSIN(1:250)12.5%10XSOLUTION 100mL T 25 g/L trypsin in normal saline dilute in a balanced salt solution without calcium and magnesium salts without phenol red Storage: Below -10°C

9340 TRYPSINEDTA1XSOLUTION 100mL T 0.5 g/L trypsin (1:250)1 and 0.2g/LEDTAtetrasodiumsaltinnormalsaline with phenol red Storage: Below -10°C

9341 TRYPSINEDTA1XSOLUTION 100mLT 0.5 g/L trypsin (1:250)1 and 500 mL 0.2g/LEDTAtetrasodiumsaltin hanks’ balanced salt solution with phenol red without calcium and magnesium salts without sodium bicarbonate Storage: Below -10°C

9342 TRYPSINEDTA10XSOLUTION 100mL T 5.0 g/L trypsin (1:250)1 and 2.0g/LEDTAdisodium2H20innormalsaline without phenol red Storage: Below -10°C

1 (800) 437-5706 • 1 (949) 261-7800


24

Cell Culture ProductsCell Culture Sera


BOvINE CALF SERUM


2014 FORMULAFEDBOVINECALFSERUM 500mLT iron supplemented 1 L less than 16 weeks Storage: Below -10°C

FETAL BOvINE SERUM


3000A FETALBOVINESERUM 100mL T cell culture grade 500 mL includes extensive documentation Storage: Below -10°C

3003 HEATINACTIVATEDFETALBOVINESERUM 100mLT Storage: Below -10°C 500 mL

NEWBORN BOvINE SERUM


6000 NEWBORNBOVINESERUM 500mLT less than 7 days 1 L Storage: Below -10°C

HORSE SERUM


4023 DONORHORSESERUM 100mLT controlled standing herd 500 mL Storage: Below -10°C

www.irvinesci.com


25

Cell Culture ProductsMycotrim® TC Screening for Cell Cultures


T500-000 MYCOTRIM® TC 12 flasks/box Storage: 2° to 8°C for in vitro diagnostic use control sold separately

MYCOTRIM® TC Providesbothpresumptiveanddefinitiveindicationsofmycoplasmacontaminationinaone-stepprocedure.TheMYCOTRIM® TC flask, which contains both agar and broth media, is inoculated with 1.0 mL of test specimen. Within four days after inoculation, contaminated cultures may show a color change. The color change provides presumptive indication of mycoplasma contamination. Low titers of contaminants may require longer growth periods or reinoculation with the mycoplasma enriched broth. Microscopic observation provides definitive positive evidence of mycoplasma contamination.

1 (800) 437-5706 • 1 (949) 261-7800


26

Cell Culture ProductsFlexible Packaging

Irvine Scientific offers a wide range of options for your packaging needs. Our flexible packages are sourced from approved vendors offering the highest quality of bags. We have developed solid relationships with our suppliers, which ultimately provides our customers with competitive pricing and faster turn around times to meet their custom packaging needs.

Our Bags are Gamma Irradiated with 25-38 kGy. Whether you are interested in custom filled or empty bags, we will provide you with a vendor Certification of Analysis and a Certification of Radiation to meet your QualityandRegulatorydocumentationrequirements.

Standard flexible packaging is available in the following sizes:• 10Land20Lmediabags• 50L,100Land200Lmanifoldassemblies

Customflexiblepackagingupto1000Lisalsoavailable.Pleasecontactourindustrial cell culture technical department to receive more information about our standard and custom flexible packaging options.

Customer Benefits are realized with this disposable packaging, especially when dealing with large volumes of media. The time and expense of cleaning and sterilization are eliminated. The film used in our bags have been specifically designed to provide a gas barrier layer, which means your media’s integrity is not jeopardized. And, of course, all of our bags have passedUSPClassVItesting,whichiscontainedinthevalidationpacketthatwe are more than glad to share with you.

www.irvinesci.com


27

Cell Culture ProductsQuality Systems

QUALITY ASSURANCEProducts manufactured by Irvine Scientific are classified as medical devices by the Food and Drug Administration (FDA). They are produced in compliance with the FDA’s current Good ManufacturingPractices (cGMP’s), utilizing detailed production protocols and qualitycontrol test procedures.

Serum processing facilities within Irvine Scientific are specifically designed and routinely monitored for adherence to environmental controls. Production and testing is performed by our highly trainedprofessional staff using approved methodologies. All products must meet rigid standards of performance prior to release for sale.

COLLECTIONAlltissueculturegradeanimalseraarecollectedWITHINTHEUNITEDSTATES inUSDA inspected facilitieswhere animals are examined ante-and post-mortem; or from controlled standing herds (equine) maintained under conditions specified by the Code of Federal Regulations (CFR) Title9,Part117.3.

Irvine Scientific’s Quality Control laboratory prequalifies sera by testingsamples for endotoxin, hemoglobin, total protein, and osmolality. Equine sera are tested at the donor level for Equine Infectious Anemia (EIA) by the Coggins Method prior to purchase.

All raw serum is frozen immediately after collection and the serum temperature is monitored throughout storage and processing to maintain quality.

PROCESSINGApproved filtration and filling protocols include in-process testing for both filter integrity and product quality. Serum is passed through a series of filters including 0.1 micron filters for removal of mycoplasma. Aseptic filling and capping is performed within a Class 100 environment. Product is labeled and immediately frozen for storage. Finishedproduct testing is performed on all lots in accordance with written standard operating procedures and finished product specifications as a requirement for final release.

Dialyzed Sera: Serum is dialyzed against normal saline using a 20,000 MW cutoff membrane. All dialyzed sera are sterile-filtered and tested using procedures for standard serum products. Any serum product can be dialyzed uponrequest.Pleaseinquireforpricequotation.

Heat Inactivated Serum: Serum is heat inactivated in bulk according to approved methodologies at a thermostatically controlled temperature of 56°C ± 1°C for 30 minutes. Filtration and filling are performed using procedures for standard serum products. Heat inactivation can also be performed on bottled serum upon request. Please inquire for price quotation.

QUALITY CONTROL TESTINGQuality Control samples are examined for bacterial and fungal contamination throughout a 14 day incubation on fluid thioglycollate and soybean-casein digest media per CFR Title 21, part 610.12.

Mycoplasma detection utilizes the DNA bisbenzamide fluorochrome stain (Hoechst 33258) in a method described by Barile from growth support cells.

Various cell lines are grown over several passages in control basal media supplemented with control serum in parallel to control basal media supplemented with the test serum. Cells are examined for rate of growth, cell density, morphology, and evidence of toxicity or cytopathiceffects(CPE).

Endotoxin is measured utilizing the LAL gel clot methodology. Test samples are screened for inhibition/enhancement. All sera are heat treated in boiling water for a minimum of 2 minutes to denature the enzymes that interfere with the enzyme cascade reaction of detecting endotoxin (Associates of Cape Cod - LAL Methodology Workshop, 10/94). EndotoxintestresultsarereportedinEndotoxinUnitspermilliliter(EU/mL) in accordance with the most current United States Pharmacopeia(USP)<85>BacterialEndotoxinsTest.

IgG testing is performed on fetal bovine serum, utilizing a radial immunodiffusion methodology.

Hemoglobin testing is performed utilizing a colorimetric methodology. Test results are a measurement of total hemoglobin and not specific hemoglobin fractions.

Biochemical testing includes pH, osmolality, Total Protein, GammaGlobulin,FolicAcid,ProteinElectrophoresis (FBSonly) and a completechemistry panel.

Viral testing is performed at a veterinary diagnostic laboratory to meet requirements as specified in CFR Title 9, Part 113. Testing includescytopathic observation, Hemadsorption, Inclusion bodies, FA staining and Serum Antibody.

SAMPLESSamples of serum can be provided for the purpose of testing a particular lot. Reserved lots will be held for three weeks from the date the sample is shipped.Uponcompletionof testing,apurchaseorder for theamountreserved is required to secure the serum. The reserve is automatically cancelled at the end of the three weeks unless an extension is granted. Minimum quantity for lot reservation is 10 liters.

1 (800) 437-5706 • 1 (949) 261-7800


28

Technical InformationContents

Antibiotics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

28

www.irvinesci.com


This table is provided as a guide in antibiotic selection. A comprehensive pharmacology text should be consulted for information on antibiotic incompatibilities and all other properties not included in this table.

Product Catalog # Inhibits1 Functional Mechanism Suggested Conc2 Stability at 37Þ C3 Storage

Gentamicin Sulfate Solution,

50 mg/mL H2O

9355 POS,NEG,Mycoplasma

Binds to ribosome at 30S subunit,interfering with

bacterial protein synthesis

1 mL/L 5Days 15° to 30°C

1 POS=GramPositiveBacteria NEG=GramNegativeBacteria

2 ConcentrationforSolutions=mLliquid/Lmedium ConcentrationforPowdersisreportedinmilligramsofantibiotic/Lmedium;

the appropriate quantity to add per liter of medium should be adjusted by the antibiotic content of the lot of powder.

3 DatafromTCAManual

Technical InformationAntibiotics

29

1 (800) 437-5706 • 1 (949) 261-7800



30

Irvine ScientificIndex

9144 ALPHAMEMEARLE’SSALTS 179142 ALPHAMEMEARLE’SSALTSWITHOUTNUCLEOSIDES 179195 CLICK’SMEDIUM(EHAAMedium) 159041 DEFICIENTDMEHIGHGLUCOSE 159031 DMEHIGHGLUCOSE 159024 DMEHIGHGLUCOSEwithoutL-GLUTAMINE 154023 DONORHORSESERUM 249314 EDTASOLUTION0.526mM 233000A FETALBOVINESERUM 242014 FORMULAFEDBOVINECALFSERUM 249355 GENTAMICINSULFATESOLUTION 229058 HAM’S F-12 169052 HAM’SF-12/DMEHIGHGLUCOSE1:1MIXTURE 169077 HAM’SF-12K(KAIGHN’SNUTRIENTMIXTUREF-12) 16T151 HB101®LYOPHILIZEDSUPPLEMENT 14T007 HB101®POWDERKIT 14T000 HBBASALLIQUID 149230 HBSS10X-HANKS’BALANCEDSALTSOLUTION 199228 HBSS1X-HANKS’BALANCEDSALTSOLUTION 199220 HBSS1X-HANKS’BALANCEDSALTSOLUTION 193003 HEATINACTIVATEDFETALBOVINESERUM 249319 HEPESBUFFERSOLUTION1M 229343 IRON CHELATE 1391101 IS293LIQUIDSERUM-FREEMEDIUM 1291107 IS293-V™LIQUIDSERUM-FREEMEDIUM 129194 ISBAC™LIQUIDSERUM-FREEMEDIUM 1391108 ISCHOFEED-CD™ 1091120 ISCHO-CDXP™ 1194110 ISCHO-CDXP™ 1194114 ISCHO-CDXP™ 1191121 ISCHO-CDXP™W/HYDROLYSATEBLENDXP™ 1194113 ISCHO-CDXP™W/HYDROLYSATEBLENDXP™ 1191100 ISCHO-CD4™LIQUIDCHEMICALLY-DEFINEDMEDIUM 1094104 ISCHO-CD4™POWDERCHEMICALLY-DEFINEDMEDIUM 10

91119 ISCHO-CD™LIQUIDCHEMICALLY-DEFINEDMEDIUM 1094111 ISCHO-CD™POWDERCHEMICALLY-DEFINEDMEDIUM 1091122 ISCHO-FEED-CDXP™ 1191109 ISCHO™LIQUIDSERUM-FREEMEDIUM 109197 ISCHO-V™LIQUIDSERUM-FREEMEDIUM 1094101 ISCHO-V™POWDERSERUMFREEMEDIUM 1091105 ISGRO®LIQUIDSERUM-FREEMEDIUM 1394109 ISHYDROLYSATEBLENDXP™ 1191104 ISMAB-CD™LIQUIDCHEMICALLY-DEFINEDMEDIUM 1391103 ISPRO®LIQUIDSERUM-FREEMEDIUM 139032 ISCOVE’SMODIFIEDDULBECCO’SMEDIUM 169317 L-GLUTAMINESOLUTION 229090 McCOY’SMEDIUM5A 169126 MEM 1X EARLE’S SALTS 179130 MEM NEAA 1X EARLE’S SALTS 17T500-000 MYCOTRIM®TC 256000 NEWBORNBOVINESERUM 249304 NON-ESSENTIALAMINOACIDS100X 2296850 OPTIMIZEDHYDROLYSATEMIXTUREFORCHOCELLS 209242 PBS10X-DULBECCO’SPHOSPHATEBUFFEREDSALINESOLUTION 199236 PBS1X-DULBECCO’SPHOSPHATEBUFFEREDSALINESOLUTION 199240 PBS1X-DULBECCO’SPHOSPHATEBUFFEREDSALINESOLUTION 199281 POTASSIUMCHLORIDESOLUTION0.075N 199160 RPMIMEDIUM1640 189159 RPMIMEDIUM16401XHEPES 189157 RPMIMEDIUM16401XHEPESW/L-GLUTAMINE 189161 RPMIMEDIUM1640W/L-GLUTAMINE 189342 TRYPSINEDTA10XSOLUTION 239340 TRYPSINEDTA1XSOLUTION 239341 TRYPSINEDTA1XSOLUTION 239336 TRYPSIN(1:250)12.5%10XSOLUTION 2396857 ULTRAFILTEREDSOYHYDROLYSATE 2096863 ULTRAFILTEREDYEASTHYDROLYSATE 209309 WATERFORINJECTION(WFI)GRADEWATER* 21

ALPHABETICAL INDEXCatalog Number Description Page No.

Catalog Number Description Page No.

www.irvinesci.com


Headline for TOC

31

Irvine ScientificIndex

2014 FORMULAFEDBOVINECALFSERUM 243003 HEATINACTIVATEDFETALBOVINESERUM 244023 DONORHORSESERUM 246000 NEWBORNBOVINESERUM 249024 DMEHIGHGLUCOSEwithoutL-GLUTAMINE 159031 DMEHIGHGLUCOSE 159032 ISCOVE’SMODIFIEDDULBECCO’SMEDIUM 169041 DEFICIENTDMEHIGHGLUCOSE 159052 HAM’SF-12/DMEHIGHGLUCOSE1:1MIXTURE 169058 HAM’S F-12 169077 HAM’SF-12K(KAIGHN’SNUTRIENTMIXTUREF-12) 169090 McCOY’SMEDIUM5A 169126 MEM 1X EARLE’S SALTS 179130 MEM NEAA 1X EARLE’S SALTS 179142 ALPHAMEMEARLE’SSALTSWITHOUTNUCLEOSIDES 179144 ALPHAMEMEARLE’SSALTS 179157 RPMIMEDIUM16401XHEPESW/L-GLUTAMINE 189159 RPMIMEDIUM16401XHEPES 189160 RPMIMEDIUM1640 189161 RPMIMEDIUM1640W/L-GLUTAMINE 189194 ISBAC™LIQUIDSERUM-FREEMEDIUM 139195 CLICK’SMEDIUM(EHAAMedium) 159197 ISCHO-V™LIQUIDSERUM-FREEMEDIUM 109220 HBSS1X-HANKS’BALANCEDSALTSOLUTION 199228 HBSS1X-HANKS’BALANCEDSALTSOLUTION 199230 HBSS10X-HANKS’BALANCEDSALTSOLUTION 199236 PBS1X-DULBECCO’SPHOSPHATEBUFFEREDSALINESOLUTION 199240 PBS1X-DULBECCO’SPHOSPHATEBUFFEREDSALINESOLUTION 199242 PBS10X-DULBECCO’SPHOSPHATEBUFFEREDSALINESOLUTION 199281 POTASSIUMCHLORIDESOLUTION0.075N 199304 NON-ESSENTIALAMINOACIDS100X 229309 WATERFORINJECTION(WFI)GRADEWATER* 219314 EDTASOLUTION0.526mM 239317 L-GLUTAMINESOLUTION 22

9319 HEPESBUFFERSOLUTION1M 229336 TRYPSIN(1:250)12.5%10XSOLUTION 239340 TRYPSINEDTA1XSOLUTION 239341 TRYPSINEDTA1XSOLUTION 239342 TRYPSINEDTA10XSOLUTION 239343 IRON CHELATE 139355 GENTAMICINSULFATESOLUTION 2291100 ISCHO-CD4™LIQUIDCHEMICALLY-DEFINEDMEDIUM 1091101 IS293LIQUIDSERUM-FREEMEDIUM 1291103 ISPRO®LIQUIDSERUM-FREEMEDIUM 1391104 ISMAB-CD™LIQUIDCHEMICALLY-DEFINEDMEDIUM 1391105 ISGRO®LIQUIDSERUM-FREEMEDIUM 1391107 IS293-V™LIQUIDSERUM-FREEMEDIUM 1291108 ISCHOFEED-CD™ 1091109 ISCHO™LIQUIDSERUM-FREEMEDIUM 1091119 ISCHO-CD™LIQUIDCHEMICALLY-DEFINEDMEDIUM 1091120 ISCHO-CDXP™ 1191121 ISCHO-CDXP™W/HYDROLYSATEBLENDXP™ 1191122 ISCHO-FEED-CDXP™ 1194101 ISCHO-V™POWDERSERUMFREEMEDIUM 1094104 ISCHO-CD4™POWDERCHEMICALLY-DEFINEDMEDIUM 1094109 ISHYDROLYSATEBLENDXP™ 1194110 ISCHO-CDXP™ 1194111 ISCHO-CD™POWDERCHEMICALLY-DEFINEDMEDIUM 1094113 ISCHO-CDXP™W/HYDROLYSATEBLENDXP™ 1194114 ISCHO-CDXP™ 1196850 OPTIMIZEDHYDROLYSATEMIXTUREFORCHOCELLS 2096857 ULTRAFILTEREDSOYHYDROLYSATE 2096863 ULTRAFILTEREDYEASTHYDROLYSATE 203000A FETALBOVINESERUM 24T000 HBBASALLIQUID 14T007 HB101®POWDERKIT 14T151 HB101®LYOPHILIZEDSUPPLEMENT 14T500-000 MYCOTRIM®TC 25

NUMERICAL INDEXCatalog Number Description Page No.

Catalog Number Description Page No.

1 (800) 437-5706 • 1 (949) 261-7800



Irvine Scientific

32

©2009 Irvine Scientific P/N 40536 Rev.7

Irvine Scientific2511 Daimler Street, Santa Ana, CA 92705-5588Phone: 1 800 437 5706 · Fax: 1 949 261 6522www.irvinesci.com

Irvine Scientific - IrelandUnit 31, Newtown Business & Enterprise Park Newtownmountkennedy · Co. Wicklow · IrelandPhone: +353 1 281 99 20 · Fax: +353 1 281 99 28

Industrial Cell Culture Product Catalog

Documents

Industrial Cell Culture Product Catalog...TECHNICAL SERvICE Technical assistance is available to answer your questions regarding all Irvine Scientific products. We also provide Material