11
LAMPIRE BIOLOGICAL LABORATORIES Tel: 215.795.2838 www.lampire.com [email protected] Dear Colleagues, I would like to extend my thanks to you, our clients, for your continued interest in Lampire Biological Laboratories, Inc. Recently, the Lampire Team came together to examine how it might better serve our clients during these challenging economic times. We began by reviewing how we started, where we came from and where we want to go. From Lampire’s inception, customer service has always been a priority. Today, we find this is still one of the most important resources we have to offer our clients. With our expertise, we better understand our client’s needs which allows for internal efficiencies and consequently price savings for our clients. Our relationships with clients have been reciprocal. Over the years, while servicing their needs, clients have become our mentors and promoted company growth and expansion. I hope these mutually beneficial relationships will continue to flourish. At Lampire we are looking optimistically to the future. Our core antibody production business remains strong and continues to expand. We are experiencing growth in many exciting areas; you will notice further development of the Lampire Cell Culture bag, expanded contract manufacturing capabilities and the addition of zebrafish teratogenicity studies. As we release our updated Products and Services Catalog, we will continue to rely on our website, www.lampire.com, to provide our customers with a convenient search and purchase experience, as well as up to the minute product listings, pricing, and promotions. Lampire now owns and operates five separate manufacturing sites for the processing and finishing of products. In the coming year, four of the five sites will be upgraded, receiving either additions or brand new facilities. The Bioprocessing Laboratory has increased our capacity for contract control manufacturing, hybridoma development, cell culture services, protein purification, bulk filtration, and antibody processing. Our ability to produce custom rabbit antibodies has been greatly enhanced, allowing us to offer high quality antibodies at competitive prices with rapid turnaround. Additionally we will soon release the next generation of the efficient, economical and environmentally friendly LAMPIRE Cell Culture Bag. Lampire recently made improvements to our internal Information Technology infrastructure to allow for secure email exchange with clients. Lampire’s enhanced Customer Support and Project Management Department is on call to answer your questions promptly and accurately. The Department may be contacted via email at [email protected] or at 215-795-2838. To contact Technical Support please email at [email protected] or call 215-795-2300. As always, I appreciate any direct client communication and welcome you to bring your questions, comments or concerns to my direct attention anytime via email at [email protected] or at 215-795-2838. Thanks to you, the scientific professionals of industry, academia, and government agencies worldwide, LAMPIRE has grown steadily since its inception in 1977; growth which has been supported by one-on-one relationships with each of our customers. Now more than ever, you can count on our commitment to your satisfaction. If for any reason you are not happy, we'll do our best to make it right. We look forward to continuing to provide cost savings and excellent service to our existing customers and developing relationships with new customers as we move into the future. Sincerely, Gregory F. Krug President

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Page 1: LAMPIRE · Peptides are provided with Mass Spectrometry and HPLC Quality Control data to assure a consistent, reliable product. LBL IMMUNOCHEMICALS & REAGENTS: LAMPIRE offers purified

LAMPIREBIOLOGICAL LABORATORIES Tel: 215.795.2838 www.lampire.com [email protected]

Dear Colleagues,

I would like to extend my thanks to you, our clients, for your continued interest in Lampire BiologicalLaboratories, Inc. Recently, the Lampire Team came together to examine how it might better serve our clientsduring these challenging economic times. We began by reviewing how we started, where we came from andwhere we want to go.

From Lampire’s inception, customer service has always been a priority. Today, we find this is still one of themost important resources we have to offer our clients. With our expertise, we better understand our client’sneeds which allows for internal efficiencies and consequently price savings for our clients. Our relationshipswith clients have been reciprocal. Over the years, while servicing their needs, clients have become ourmentors and promoted company growth and expansion. I hope these mutually beneficial relationships willcontinue to flourish.

At Lampire we are looking optimistically to the future. Our core antibody production business remains strongand continues to expand. We are experiencing growth in many exciting areas; you will notice furtherdevelopment of the Lampire Cell Culture bag, expanded contract manufacturing capabilities and the additionof zebrafish teratogenicity studies.

As we release our updated Products and Services Catalog, we will continue to rely on our website,www.lampire.com, to provide our customers with a convenient search and purchase experience, as well as upto the minute product listings, pricing, and promotions.

Lampire now owns and operates five separate manufacturing sites for the processing and finishing of products.In the coming year, four of the five sites will be upgraded, receiving either additions or brand new facilities.The Bioprocessing Laboratory has increased our capacity for contract control manufacturing, hybridomadevelopment, cell culture services, protein purification, bulk filtration, and antibody processing. Our ability toproduce custom rabbit antibodies has been greatly enhanced, allowing us to offer high quality antibodies atcompetitive prices with rapid turnaround. Additionally we will soon release the next generation of theefficient, economical and environmentally friendly LAMPIRE Cell Culture Bag. Lampire recently madeimprovements to our internal Information Technology infrastructure to allow for secure email exchange withclients.

Lampire’s enhanced Customer Support and Project Management Department is on call to answer yourquestions promptly and accurately. The Department may be contacted via email at [email protected] orat 215-795-2838. To contact Technical Support please email at [email protected] or call 215-795-2300. Asalways, I appreciate any direct client communication and welcome you to bring your questions, comments orconcerns to my direct attention anytime via email at [email protected] or at 215-795-2838.

Thanks to you, the scientific professionals of industry, academia, and government agencies worldwide,LAMPIRE has grown steadily since its inception in 1977; growth which has been supported by one-on-onerelationships with each of our customers. Now more than ever, you can count on our commitment to yoursatisfaction. If for any reason you are not happy, we'll do our best to make it right. We look forward tocontinuing to provide cost savings and excellent service to our existing customers and developing relationshipswith new customers as we move into the future.

Sincerely,

Gregory F. KrugPresident

Page 2: LAMPIRE · Peptides are provided with Mass Spectrometry and HPLC Quality Control data to assure a consistent, reliable product. LBL IMMUNOCHEMICALS & REAGENTS: LAMPIRE offers purified

To provide consistently and competitively, high quality, reliable

products and services in conformity with our customers'

requirements, specifications, and standards.

In pursuit of this mission, we are dedicated to the following:

Treating our customers in a courteous, thoughtful manner;

Fostering innovation and creativity in research;

Producing high quality products at fair prices;

Striving to GET IT RIGHT THE FIRST TIME... EVERY TIME!

OUR MISSION/QUALITY POLICY

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LAMPIREBIOLOGICAL LABORATORIES Tel: 215.795.2838 www.lampire.com [email protected]

CORPORATE CREED

LAMPIRE Biological Laboratories was founded on the principle

that each and every customer is entitled to our best effort at all times and

that each employee consciously and constantly strives to improve that effort.

We believe our customers are the life-blood of our business

and deserve the most courteous and attentive treatment we can give them.

We at LAMPIRE believe every customer deserves

our total commitment to the following:

Quality performance by every employee;

The finest quality research we can conduct;

The best quality care for client animals and otherproprietary biological systems and materials

entrusted to us for production, optimization, or storage;

The highest quality products we can manufacture;

Thoughtful, courteous, quality service with every contact;

Continuous efforts to improve performance by every department.

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ABO

UT LA

MPIRE

ABOUT LAMPIREPRESIDENT’S MESSAGE & MISSION STATEMENT

PRODUCTS & SERVICES OVERVIEWSCIENTIFIC CAMPUSES | HOW TO ORDER

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LAMPIREBIOLOGICAL LABORATORIES Tel: 215.795.2838 www.lampire.com [email protected]

1LAMPIREBIOLOGICAL LABORATORIES Tel: 215.795.2838 www.lampire.com [email protected]

CORPORATE PROFILE

CORPORATE STRUCTUREWith over 35 years of antibody, tissue culture, immunochemistry, and blood product experience, LAMPIRE brings uniqueknowledge and skill to its customers. Since inception, LAMPIRE has grown steadily and currently offers excellent productsand services in the following areas:

LBL CUSTOM ANTIBODIES: LAMPIRE offers easy-to-initiate, pre-packaged POLYCLONAL services andcustom protocols designed specifically for your needs. Each project begins with a review by our expert staff who will helpwith species selection, antigen design, and immunization protocol. Additional services include pre-immune screening,antigen conjugation, titer testing, and antibody purification, and conjugation. Comprehensive MONOCLONAL servicesfrom research- to bulk-scale production, hybridoma development, cell line optimization, serum-free production, supernatantconcentration, antibody purification and characterization, plus cell bank production, testing, and storage. To complement thepolyclonal and monoclonal services, LAMPIRE offers custom peptide design and synthesis. The convenient HARMONY-LINE Services combine peptide synthesis and polyclonal antibody development into a low package price (page 53). Peptidesare provided with Mass Spectrometry and HPLC Quality Control data to assure a consistent, reliable product.

LBL IMMUNOCHEMICALS & REAGENTS: LAMPIRE offers purified immunoglobulins, secondaryantibodies, and conjugates of these products in research and bulk scale. Each lot is produced within the guidelines of astringent Quality System to assure consistent product characteristics and performance.

LBL BLOOD & BIOLOGICS: LAMPIRE is an industry leader in the collection of donor- and abattoir-derived,animal tissues and organs and offers an extensive array of products. The company maintains closed herds for the productionof donor whole blood, serum, and plasma. A variety of species are available including alligator, bovine, chicken, donkey,goat, horse, porcine, and sheep. Bovine-derived products are traceable for U.S. origin. Human whole blood, serum, plasma,and disease state plasma are subject to the quality control measures required by FDA-licensed collection facilities.

LBL TECHNOLOGY: The LAMPIRE Cell Culture Bags are an efficient, economical and environmentallyresponsible cell culture alternative to many other traditional systems such as flasks and roller bottles. These microscopically-transparent, single-use bags facilitate the handling and expansion of many different cell culture types from standardhybridoma cells/antibody production to customized cell propagation and recombinant protein production. Ranging in sizefrom 50ml up to 2 liter, the presterilized bags can be filled to the full capacity for higher productivity per incubator space.The LAMPIRE Cell Culture Bags are equipped with a wide access port for easy media delivery, sampling and harvesting.The high gas permeability of the bag material maximizes cell growth and yields over extended growth periods. LAMPIRECell Culture Bags are easy to use from start to finish-- easy to fill, easy to observe cell growth, easy to maintain, and easydisposal.

LAMPIRE's 400-acre animal facility in Everett, PA - featuring our state-of-the-art polyclonal production unit.

©2012 LAMPIRE® Biological Labs, Inc.

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CORPORATE PROFILE

LAMPIREBIOLOGICAL LABORATORIES Tel: 215.795.2838 www.lampire.com [email protected]

Markets ServedLAMPIRE has earned primary vendor status with pharmaceutical, diagnostic, biotechnology, and medical devicecorporations worldwide. Commitment to Quality and Customer Service has established LAMPIRE as a key resource forclients through the research and development, scale-up, and optimization stages of product development and subsequentproduction. LAMPIRE also serves academia and government research agencies involved in the areas of immunology, cellbiology, cell signaling, pathology, molecular biology, microbiology, and clinical medicine.

Commitment to ValueLAMPIRE strives to offer excellent products at competitive prices. Our ability to accomplish this is the result ofproduction efficiencies and the strategic location of facilities in eastern and central Pennsylvania.

Professional TeamLAMPIRE's staff of trained professionals includes Ph.D. scientists and certified Laboratory Animal Technicians to assureyour project's success and establish lot-to-lot consistency of finished products.

Ph.D. Scientists are actively involved in all facets of LAMPIRE's products and services: From the development and production of stock inventory items to the design of custom antibody and immunoassay development projects.Staff Veterinarians provide animal healthcare supervision, preventive medicine, and nutrition analysis.AALAS Certified Staff: Laboratory Animal Technologists participate in continuous cGMP training.Institutional Animal Care and Use Committee (IACUC) physically inspects each facility, meets on a regular basis to examine all protocols to ensure compliance with the Animal Welfare Act, and follows the IACUC "Guidefor the Care and Use of Laboratory Animals."Customer Support is always available and pleased to answer your questions, Monday through Friday from 8:30 a.m. to 6:00 p.m. Eastern Time.

SCIENTIFIC CAMPUSESFounded with a single facility in 1977, LAMPIRE Biological Laboratories now consists of five high-tech facilitiesthroughout Pennsylvania, each dedicated to a unique discipline of biotechnology, and has expanded to the West Coast.The following pages illustrate merely a small portion of the expertise and capabilities housed at LAMPIRE.

Corporate Headquartersand Animal Facility:Ottsville, PA is home to LAMPIRE'scorporate headquarters and a 40-acre,small- and large-animal facility thatfeatures environmentally-controlledanimal suites, processing laboratories,and donor herd housing.

LAMPIREBIOLOGICAL LABORATORIES Tel: 215.795.2838 www.lampire.com [email protected]

2

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CORPORATE PROFILE

LAMPIREBIOLOGICAL LABORATORIES Tel: 215.795.2838 www.lampire.com [email protected]

3

400-Acre Small and LargeAnimal Facility:Located in Everett, PA, this site houses awide variety of domestic farm animals usedfor custom antisera, donor sera, and red cellproduction programs. Featured at this site isLAMPIRE's state-of-the-art, small-animalvivarium. The 11,000 sq. ft. facility featureswall-to-wall epoxy-quartz flooring, 24-hourmonitoring of temperature and humidity,separate air handling systems for animalquarters and cage washing areas, positive air pressure inside the facility to minimize the risk of contamination,and two back-up generators in the event of power failure. The facility houses 1,500 rabbits and complementsLAMPIRE's original 40-acre antibody development site in Ottsville, PA.

Everett Bio-Processing Center:A state-of-the-art 18,000 square footlaboratory facility. Our new facilityoffers immunochemistry service,specialty organ and tissue processing,processing of blood products, largefreezer and refrigeration storagecapability, and high techcommunication.

Biotechnology Research and Resource Center:LAMPIRE's state-of-the-art Biotechnology Center islocated in Pipersville, PA. This 18,000 sq. ft. facilityfeatures Class 10,000 clean room manufacturing andtesting laboratories, cell banking services, plus tissueculture and purification laboratories, as well asenvironmentally-controlled suites for contractmanufacturing, plus conatins our newly expanded High-Tech Vivarium.

Processing Laboratory:Raw materials are processed at our facility inCoopersburg, PA, where antibody purification,blood processing and bulk filtration are performed.The facility houses a clean room for controlledprocedures and services and dedicated processingareas for abattoir collections.

LAMPIREBIOLOGICAL LABORATORIES Tel: 215.795.2838 www.lampire.com [email protected]

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CORPORATE PROFILE

LAMPIREBIOLOGICAL LABORATORIES Tel: 215.795.2838 www.lampire.com [email protected]

High-Tech Husbandry Pharm FacilitiesLAMPIRE combines the latest techniques in animal husbandry with state-of-the-art facilities to provide a uniqueenvironment for the consistent production of high quality antisera and blood products. At LAMPIRE, the farms are referredto as "pharms" due to their significant contribution to the global pharmaceutical market. All species are housed at twogeographically separate sites, a design that helps assure animal safety and minimizes the risk of herd contamination. Bothanimal facilities are located in the Northeastern United States, which enables a high level of animal and product safety:

Risk management programs are in place to prevent production interruption;Animals are housed in a biosecure, Tested Specific Pathogen-Free (TSPF) environment.

Documentation & Animal TraceabilityWith increased worldwide attention regarding the identification and traceability of biological raw materials containedwithin drugs, vaccines, and medical devices, LAMPIRE continues to lead as a global supplier of animal-based products. Toensure the disease-free status of all LAMPIRE animals, a rigorous screening program is part of a Quality System whichincludes serological screening, quarantine programs, feed history, health records, and documented animal lineage.LAMPIRE's ability to provide a high level of traceability and disease assurances enables the worldwide shipment ofanimal-based products, including bovine, for

Medical device production worldwide;Key reagents for the development of coagulation-related and in vitro diagnostic products;Human blood replacements in the demonstration of surgical support equipment in hospital operating rooms and surgical suites throughout the United States;Tissue culture reagents for media production.

Whether it is a one-time collection for research use or the routine supply of a critical raw material for the production of amedical device or pharmaceutical, LAMPIRE's staff will provide documentation needed to meet applicable FDA andEuropean guidelines. The ability to provide documentation on each animal, including place of birth and diet, provides theclient with complete traceability.

All LAMPIRE animal facilities are AAALAC-accredited, EC No. 1774/2002 Regulation-compliant, USDA-registered, andhold NIH Animal Welfare Assurance from the Office of Laboratory Animal Welfare (NIH-OLAW). Animals are uniquelyidentified and are monitored to ensure continued good health and production capabilities. These data are documented inindividual health records as part of a donor blood production program.

Biosecurity and Quarantine ProceduresBiosecurity relates directly to the overall herd maintenance and production programs. LAMPIRE's programs specificallyaddress the housing of all animals and involve controlled access to production herds. Animal housing, personnel andanimal flow, facility cleaning, and feeding operations are all integral parts of facility design.

In addition to daily observation, all LAMPIRE animals are monitored by accredited, staff veterinarians. The overallmonitoring program involves several protective measures:

Quarantine procedures;Serological screening;Monthly veterinarian health assessments;Monthly production reports and health reports;Programs detailing the access of personnel, vehicles, and animals run under the auspices of the facility management staff and attending veterinarians.

LAMPIRE also has the ability to isolate animal herds upon customer request. Under such conditions, designated animalscome in contact only with other animals that are part of the same program.

Other benefits relating to facilities, staffing, animal screening, and housing includeBiosecure facility design, which includes primary and secondary enclosures;Highly trained and qualified full-time animal and maintenance staff;Documented treatment, sanitation, and animal monitoring programs;Immunization and vaccination protocols;Controlled access systems and procedures for facility access and egress;Documented feed procedures and programs.

LAMPIREBIOLOGICAL LABORATORIES Tel: 215.795.2838 www.lampire.com [email protected]

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CORPORATE PROFILE

LAMPIREBIOLOGICAL LABORATORIES Tel: 215.795.2838 www.lampire.com [email protected]

5

Feed and Water ControlFeed, forage, and water are tested routinely at LAMPIRE, helping to maintain animal health and product consistency. Inaccordance with the FDA Feed Ban, Federal Register June 5, 1997; 21 CFR Part 589 ruminants at LAMPIRE BiologicalLaboratories are fed in accordance with the following FDA Guidances:

FDA Guidance for Industry 67: Small Entities Compliance Guidance For Renderers;FDA Guidance for Industry 68: Small Entities Compliance Guidance For Protein Blenders,

Feed Manufacturers, and Distributors;FDA Guidance for Industry 70: Small Entities Compliance Guidance For Feeders of Ruminant Animals

Note: All animal feed used at LAMPIRE is certified free of ruminant-derived proteins. Current feed programs include semi-annualfeed analyses.

Quality SystemLAMPIRE maintains a Quality System designed to address the requirements of both federal and international standards,including FDA's Good Manufacturing Practice for Blood and Blood Components (21CFR606) and FDA's Medical DeviceQuality System Regulation (21CFR820). The intent of this system is to achieve LAMPIRE's quality and service objectivesby providing products and services that meet our customers' requirements.

Facility Registrations and AccreditationsLAMPIRE's facilities maintain worldwide accreditation. Our facilities are registered with AAALAC, USDA, FDA MedicalEstablishment, FDA Blood Establishment, NIH, and the European Community (EC). Our registration and accreditationnumbers are listed below.

AAALAC: 001032FDA: 2523369 (Medical Device)

2550014 (Medical Device and Blood Establishment)EC No. 1774/2002 Regulation Compliant: PA-TEC-0001

PA-TEC-0002PA-TEC-0003PA-TEC-0005

NIH Office of Lab Animal Welfare (OLAW): A3997-01USDA: 23-R-0122

23-B-0020

European Community Regulation (EC) No.1069/2009 & Regulation (EU) No. 142/2011LAMPIRE is in compliance with the European Community Regulation (EC) No. 1069/2009 and Regulation (EU) No.142/2011. These regulations establish the requirements for importation of animal-sourced materials into the EuropeanUnion (EU). These regulations apply to products used for technical purposes such as the development of pharmaceuticals,in vitro diagnostics, medical devices and laboratory reagents. LAMPIRE was the first company in the state of Pennsylvaniaand one of the first donor-animal blood products and antibody facilities in the United States to comply with this guideline.

LAMPIREBIOLOGICAL LABORATORIES Tel: 215.795.2838 www.lampire.com [email protected]

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OrderingThere are several convenient ways to place an order. Use the one that best suits your needs:

Corporate Headquarters: Western United States Regional Office: World Wide Web:Phone: 215.795.2838 Phone: 760.944.1220 www.lampire.comFax: 215.795.0237 Fax: 760.944.1270Email: [email protected] Email: [email protected]: P.O. Box 270 Post: P.O. Box 270

Pipersville, PA 18947 Pipersville, PA 18947USA USA

General Ordering GuidelinesMinimum order is $40.Every effort will be made to fulfill orders for same-day shipment if called or faxed in to our Customer Support Staff by 11 am Eastern Time. Orders placed after 11 am Eastern will be shipped the following day.Orders placed after 11 am Eastern that must be shipped the same day will incur a $55 Rush Fee.Payment is in US Dollars, due Net 30 days from the date of the invoice.Prices are subject to change without notice.The following credit cards are accepted: VISA, Mastercard, American Express.Returns: No returns are accepted without prior arrangement with our Customer Support Staff.

When ordering, please provide the following information:Contact Name & Phone Number"Bill to" and "Ship to" AddressCatalog Number and Product or Service DescriptionQuantity and Unit SizePurchase Order Number (PO #) or credit card information (When submitting a confirming PO#, please mark it as such.)Comments or Special InstructionsPreferred Freight Carrier and Account Number

ShippingFreight charges will be billed to your account with your designated carrier or may be pre-paid and added to your invoice. Please provide your FedEx, UPS, DHL, or other preferred carrier account number at the time of order placement. If none exists, please inform our Customer Support Staff and alternate arrangements will be made.If no Freight Carrier is specified at the time of confirmation of your order, a $20 surcharge will apply to cover the costs of contacting an appropriate carrier for delivery. A nominal "Box/Ice" fee is charged to defer material and handling costs. This charge varies based on the size of the shipment, but is generally between $11.75 and $25.00 per box. In addition, dry ice is added when required.

InvoicingInvoices are mailed directly to the Accounts Payable or Bill To address designated on your Purchase Order.Project Initiation Fees are invoiced upon receipt of your order.For polyclonal antibody projects, a Board/Maintenance invoice is issued monthly, summarizing the charges accrued during that calendar month. Also, Project Termination Fees are invoiced with the final monthly Board/Maintenance charge or upon written notice of exsanguination or animal disposal.International shipments incur a $110 documentation fee.CITES documentation carries with it a charge of $330.

ORDERING, SHIPPING & INVOICINGORDERING, SHIPPING & INVOICING

LAMPIREBIOLOGICAL LABORATORIES Tel: 215.795.2838 www.lampire.com [email protected] LABORATORIES Tel: 215.795.2838 www.lampire.com [email protected]

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LAMPIRE IACUC Questionnaire Form - Monoclonal Projects

LAMPIRE BIOLOGICAL LABORATORIES Tel: 215.795.2838 Fax: 215.795.0237 www.lampire.com [email protected]

6001002 Rev New

2. Species and Number of Animals

□Mice □Rat(s) □Other:________

Qty:_______ Qty:_______ Qty:_______

3. IACUC (Institutional Animal Care and Use Committee) RequirementsLampire Biological Laboratories, Inc., in compliance with federal regulations, presents each animal-use project to IACUC (InstitutionalAnimal Care and Use Committee) for approval prior to project initiation. Criteria for acceptance of a project are established in 9CFR,Chapter 1: Animal and Plant Health Inspection Service, USDA, Subchapter A – Animal Welfare. To expedite initiation of your project, please complete the following questions and assurances as thoroughly as possible. If yourcompany or institution is a USDA-registered facility with an IACUC of its own, Lampire may accept an approved Animal-Use Proposalfrom that committee. If any questions arise during our IACUC review of your project, a committee member will contact you forclarification.

Please briefly state your rationale for the appropriateness of the species of animals used for this activity: (i.e., "The use of animals is one of the best known ways to develop antibodies, mice or rats are appropriate species to produce Monoclonal Antibodies.")

Your signature below indicates that this project does not unnecessarily duplicate previous experiments or projects, the number ofanimals has been minimized and alternatives to animal use have been considered.

_____________________________________ ___________________Client Signature Date

_____________________________________Print Name

4. Project Approval (LAMPIRE use only)

_______________________________ ___________Lampire IACUC Approval Date

_______________________________ ___________Lampire Project Management Approval Date

_______________________________ ___________Lampire Technical Support Approval Date

Print a copy of the completed form for your records.

Submit completed form via EMAIL or fax completed form to 215-795-0237

1. General Information Company / Institution: Project Name / Number:

Investigator Name: PO#

Contact Name:

E-mail:

Phone:

Fax: