12
cQrex cell culture ingredients for research, manufacturing and clinical applications

cQrex cell culture ingredients - Evonik Health Carehealthcare.evonik.com/...Brochure-Cell-Culture.pdf · brochure. Boosters When ... cQrex™ cell culture ingredients from Evonik

  • Upload
    dohuong

  • View
    241

  • Download
    1

Embed Size (px)

Citation preview

Page 1: cQrex cell culture ingredients - Evonik Health Carehealthcare.evonik.com/...Brochure-Cell-Culture.pdf · brochure. Boosters When ... cQrex™ cell culture ingredients from Evonik

cQrex™ cell culture ingredientsfor research, manufacturing and clinical applications

Page 2: cQrex cell culture ingredients - Evonik Health Carehealthcare.evonik.com/...Brochure-Cell-Culture.pdf · brochure. Boosters When ... cQrex™ cell culture ingredients from Evonik

Why choose Evonik?

Evonik is the creative industrial group from Germany and one of the world’s leading specialty chemicals compa-nies with more than 33,000 Evonik employees. Media providers around the world and around the corner rely on our cell culture ingredients as we offer a unique combination of development expertise, manufacturing capabilities and service scope. Rooted in parenteral applications to exacting pharmaceutical standards and – with decades of expe-rience in microbial fermentation – at home in biotechnology, Evonik’s Health Care Business Line brings two worlds together in a hotbed of innovation for our customers.

You can count on us for consistent qual-ity from minute to metric ton scale, from lab bench to volume production. Along with the product, we deliver the peace of mind that comes from working with a partner who is a global player with manufacturing facilities in France, Ger-many and China – and technical sales offices essentially everywhere you are.

Our sites are regularly audited and operate under one global quality sys-tem that follows the same standards. And we welcome your scrutiny.

Evonik Health Care’s proven ability to address complex customer demands for

high quality cell culture nutrients comes from over sixty years of experience in manufacturing amino acids combined with advanced R&D capabilities, full back-integrated production and a global reach. It is one of the reasons we've become a preferred partner to the phar-ma and biotech industry.

If you are looking for cell culture ingre-dients, from biopharmaceutical research & development to production and even clincial applications, and need a solution provider with outstanding service and supply reliability, you’ve come to the right place.

cQrex™ IS THE EVONIK BRAND FOR CELL CULTURE SOLUTIONS WITH SCIENTIFICALLY PROVEN BENEFITS

• Highly purified amino acids: the reliable basis for reproducible cell culture media performance

• Chemically defined boosters: peptides and ketoacids overcoming key challenges in mammalian cell culture

• Products on demand: customized media ingredients from functionalized amino acids to complex molecules

• Application services: screenings and booster development at your disposal All products are animal-origin free and readily available at commercial scale.

MORE THAN AN INGREDIENT PROVIDER – A SOLUTION PROVIDER

L+L 17-01-093 Br Cell Culture CD-2.0.indd ––– 03. Mai 2017; 12:13 UhrL+L 17-01-093 Br Cell Culture CD-2.0.indd ––– 03. Mai 2017; 12:13 Uhr

Page 3: cQrex cell culture ingredients - Evonik Health Carehealthcare.evonik.com/...Brochure-Cell-Culture.pdf · brochure. Boosters When ... cQrex™ cell culture ingredients from Evonik

STANDARD QUALITY CONTROL TESTING FOR cQrex™ CELL CULTURE INGREDIENTS

FINISHED PRODUCT TESTING METHODOLOGY

Identification Specific rotation, IR, TLC

Assay USP / EP / JP

Specific rotation USP / EP / JP

Transmittance (replacing appearance test) Appearance of solution: EP

Water content USP / EP / JP

Sulphated ashes USP / EP / JP

Salts (Chlorides, sulphates, ammonia) USP / EP / JP

Heavy metals, iron, arsenic USP / EP / JP

Impurities USP / EP / JP : TLC, HPLC

Endotoxins USP / EP / JP

Microbiology USP / EP / JP

Quality is at the center of everything we do

Small differences in raw material quality can have a major impact on efficient cell cultivation. Evonik combines experience in the manufacture of clinical grade material with expertise in biotechnology to provide excellent solutions for cell culture users.

Our cQrex™ range of products is designed to cover the spectrum of appli-cations from biopharmaceutical R&D and manufacturing to medicinal applica-tions. The highest purity standards are of course imperative to guarantee repro-ducibility and meet the toughest regula-tory standards. Beyond the fact that we do not use any animal derived compo-

nents, our approach to ensuring consis-tency in terms of quality and reproduc-ible performance builds on a quality system that allows a smooth transfer from R&D to regulated production or clinical applications. Evonik Health Care stands for unique transparency: all manufacturing is in-house and with an excellent degree of backward integration.

Naturally, certificates of suitability of Monographs of the European Pharma-copoeia (CEPs) and Drug Master Files (DMFs) are available for most products.

Page 4: cQrex cell culture ingredients - Evonik Health Carehealthcare.evonik.com/...Brochure-Cell-Culture.pdf · brochure. Boosters When ... cQrex™ cell culture ingredients from Evonik

Our products

At the core of our solutions: a knowledge of chemistry, biotechnology and the building blocks of life that is unparalleled in its depth and breadth. Amino Acids

We understand that amino acids are key constituents of cell culture media and feeds. For our partners in the pharma and biotech industries, we can guaran-tee products that meet precise purity standards and fulfill key requirements

for cell culture research, development and production. This we combine with unrivalled supply security. In addition to the proteinogenic L-amino acids we also offer a range of D-, DL- and non-proteinogenic amino acids.

Please contact us with your exact requirements. You can find our full product list on the last page of this brochure.

Boosters

When performance is of the essence, it helps to have the right tools avail-able. The cQrex™ standard booster lineup consists of peptides, keto acids, special amino acid and derivatives. They are designed to stabilize components to prolong longevity, solubilize critical constituents, increase productivity, and help manage the concentration of criti-cal metabolites. All boosters are readily available at commercials scale.

OUR CQrex™ STANDARD BOOSTERS

Name Chemical name

cQrex™ AKG α-Ketoglutaric acid

cQrex™ AQ L-Alanyl-L-glutamine

cQrex™ AAQ N-Acetyl-L-alanyl-L-glutamine

cQrex™ GQ Glycyl-L-glutamine hydrate

cQrex™ GY Glycyl-L-tyrosine dihydrate

cQrex™ Carnosine β-L-alanyl-L-histidine

SOLUBILITY OF cQrex™ BOOSTERS

800

1000

1200

600

400

200

0

Solu

bilit

y in

g/L

[H₂O

, 20°

C, p

H7]

cQrex™ GQ cQrex™ AQ cQrex™ AAQ cQrex™ GY cQrex™ AKG cQrex™ Carnosine

L+L 17-01-093 Br Cell Culture CD-2.0.indd ––– 03. Mai 2017; 12:13 UhrL+L 17-01-093 Br Cell Culture CD-2.0.indd ––– 03. Mai 2017; 12:13 Uhr

Page 5: cQrex cell culture ingredients - Evonik Health Carehealthcare.evonik.com/...Brochure-Cell-Culture.pdf · brochure. Boosters When ... cQrex™ cell culture ingredients from Evonik

cQrex™ GY

Get up to 60 times more tyrosine in a neutral feed than with the free amino acid

cQrex™ AKG

A scientifically proven performance enhancer and protectant against oxidative stress

cQrex™ AQ and GQ

Avoid detrimental effects on cells and product by using stabilizing glutamine. The choice between alanine- and glycine peptides provides flexibility in media design

cQrex™ Carnosine

Prevents and even reverses senescence in primary and stem cell cultivations

cQrex™

The Evonik brand for performance-enhancing cell culture solutions with clearly documented benefits

cQrex™ AAQ

A powerful booster of cell-specific productivity that can prevent lactate accumulation

Customized products

Evonik Health Care’s flexible dipeptide technology can match virtually almost any need – up to metric ton scale. If what you need is a non-natural amino acid as linker in your mAB, count on our expertise in chemistry and biotech-nology to identify a fast and efficient process design. Your desired ingredient is not an amino acid? Take advantage of

our decades-long experience in chemi-cal and pharmaceutical custom manu-facturing – we can develop and scale up almost any compound. Should your desired ingredient be produced by bac-terial fermentation, rest assured that it is in good hands with one of the largest and most respected players in industrial biotechnology.

And if you have developed and patented a new compound and are looking for a partner to ramp up commercialization, you will see that exclusive synthesis and production are among our core capabili-ties as well.

A NEW LEVER IN YOUR CULTIVATION PROCESS

Your cell line & clone

Typical targets• More effective production

of biologicals and viral vaccines• Efficient proliferation of stem cells

Your medium Your process

cQrex™ booster

Page 6: cQrex cell culture ingredients - Evonik Health Carehealthcare.evonik.com/...Brochure-Cell-Culture.pdf · brochure. Boosters When ... cQrex™ cell culture ingredients from Evonik

Value-adding services

Customized services for our product and your targeted development. Have you already selected a production medium? In that case we can assist with testing new reagents and supplements or optimizing commercial media. Custom solutions range from special products, e. g. peptides for cell culture media R&D to special packaging, including 1 kg bags.

In addition, all screening and develop-ment activities can be rationalized by using our capabilities in statistical plan-ning and DoE (Design of Experiments). With technical services that span the gamut, we can add value at every stage on the path to market. And that includes

being at your side every step of the way towards regulatory approval. Here, our deep understanding of regula-tory demands and frameworks – includ-ing a carefully curated Drug Master File – serves to avoid pitfalls and achieve your goal in time.

TECHNICAL

MILLING• Pin mill• Hosokawa / jet mill

PACKAGING We offer various solutions to meet customer requirements

MIXING / BLENDING

• Paddle dryer• Cone dryer• Vacuum mixing dryer• Slanting dryer

ANALYTICAL SERVICES

• Amino acid analyses• Malvern particle size measurements• Microbiological measurements • Cell culture media testing• Mass spectrometry

New formulation

Evalution of results

Analysis of culture supernatant

Theoretical optimization• Data modelling• Calculation of nutrient concentrations

Empirical optimization• Screening experiments• Stepwise fortifications• Design of experiments

Cultivation

L+L 17-01-093 Br Cell Culture CD-2.0.indd ––– 03. Mai 2017; 12:13 UhrL+L 17-01-093 Br Cell Culture CD-2.0.indd ––– 03. Mai 2017; 12:13 Uhr

Page 7: cQrex cell culture ingredients - Evonik Health Carehealthcare.evonik.com/...Brochure-Cell-Culture.pdf · brochure. Boosters When ... cQrex™ cell culture ingredients from Evonik
Page 8: cQrex cell culture ingredients - Evonik Health Carehealthcare.evonik.com/...Brochure-Cell-Culture.pdf · brochure. Boosters When ... cQrex™ cell culture ingredients from Evonik

■ Innovative products of compelling quality ■ Animal origin free – guaranteed ■ cGMP compliance, ISO certification

(9001, 14001) ■ 6 decades of experience in the production

of pharmaceutical grade products ■ Positive track record for inspections, from

customers to authorities (FDA, ANSM)

■ All products are available from lab to production scale ■ Experienced and qualified staff ■ Full support from R&D to production

and clinical application ■ The ideal combination of chemical and

biotechnological expertise ■ The stability and staying power of a global player ■ The dedication of an effective service provider

Order your cQrex™ sample kit now!

Interested? Ask for our sample kit!

■ The sample kit allows you to test our substances in your system, as no cell line is quite the same

■ For standard amino acids, individual samples can be supplied upon request

COMBINATION OF OUR CURRENT LINE-UP OF BOOSTERS IN ONE KIT:

Product Solubility in water (20 °C, pH 7)

Quantity in kit

cQrex™ AQ (L-Alanyl-L-glutamine) 720 g/L 10 g

cQrex™ GQ (Glycyl-L-glutamine hydrate) 154 g/L 10 g

cQrex™ GY (Glycyl-L-tyrosine dihydrate) 34 g/L 10 g

cQrex™ AAQ (N-Acetyl-L-alanyl-L-glutamine) >500 g/L 5 g

cQrex™ AKG (α-Ketoglutaric acid) >1000 g/L 5 g

L-carnosine (β-L-alanyl-L-histidine) >300 g/L 10 g

Please contact us: [email protected]

cQrex™ cell culture ingredients from Evonik – our qualifications in a nutshell

L+L 17-01-093 Bestellkarte Cell Culture 200x287mm_RZ.indd ––– 03. Mai 2017; 12:54 UhrL+L 17-01-093 Bestellkarte Cell Culture 200x287mm_RZ.indd ––– 03. Mai 2017; 12:54 Uhr

Page 9: cQrex cell culture ingredients - Evonik Health Carehealthcare.evonik.com/...Brochure-Cell-Culture.pdf · brochure. Boosters When ... cQrex™ cell culture ingredients from Evonik

This information and all further technical advice are based on our present knowledge and experience. However, it implies no liability or other legal responsibility on our part, including with regard to existing third party intellectual property rights, especially patent rights. In particular, no warranty, whether express or implied, or guarantee of product properties in the legal sense is intended or implied. We reserve the right to make any changes according to technological progress or further developments. The customer is not released from the obligation to conduct careful inspection and testing of incoming goods. Performance of the product described herein should be verified by testing, which should be carried out only by qualified experts in the sole responsibility of a customer. Reference to trade names used by other companies is neither a recommendation, nor does it imply that similar products could not be used. cQrex™ – trademark of Evonik Industries AG and its subsidiaries.

Evonik Nutrition & Care GmbH Health Care Business Line Pharma & Food Ingredients Kirschenallee 64293 Darmstadt Germany

[email protected] www.evonik.com / cQrex

To receive a cQrex™ sample kit please enter your full and correct address in the below form. We will get in contact with you as soon as we have recieved the card and send your personal sample kit within the next weeks. Please use the postal address above or send us an email to order your kit: [email protected]. First name Postal code/City

Last name State

Company/Institution Country

Street Phone

Address line 2 E-mail address*

*We will collect, process and utilize your personal data (e.g. communication details and photos, if applicable) exclusively for organizing and implemen-ting events in the Evonik Group, as well as for our Health Care newsletter (HC Bulletin). The confidentiality of your personal information is of particular concern to us. Entering this data is voluntary. We ensure that the stored data are protected against unauthorized access.

cQrex™ sample kit – Only one step away.

L+L 17-01-093 Bestellkarte Cell Culture 200x287mm_RZ.indd ––– 03. Mai 2017; 12:54 UhrL+L 17-01-093 Bestellkarte Cell Culture 200x287mm_RZ.indd ––– 03. Mai 2017; 12:54 Uhr

Page 10: cQrex cell culture ingredients - Evonik Health Carehealthcare.evonik.com/...Brochure-Cell-Culture.pdf · brochure. Boosters When ... cQrex™ cell culture ingredients from Evonik

Product Information

cQrex™ cell culture ingredients

AMINO ACIDS AND THEIR SALTS

CAS No. GMP grade

Glycine 56-40-6

L-Alanine 56-41-7

L-Arginine-L-aspartate 7675-83-4

L-Asparagine monohydrate 5794-13-8

L-Aspartic acid 56-84-8

L-Glutamic acid 56-86-0

L-Isoleucine 73-32-5

L-Leucine 61-90-5

L-Lysine hydrochloride 657-27-2

L-Lysine-L-aspartate 27348-32-9

L-Lysine-L-glutamatedihydrate 5408-52-6

L-Lysine-L-malate 71555-10-7

L-Lysine monohydrate 39665-12-8

L-Methionine 63-68-3

L-Proline 147-85-3

L-Serine 56-45-1

L-Threonine 72-19-5

L-Tryptophan 73-22-3

L-Valine 72-18-4

Potassium L- glutamate hydrate 6382-01-0

BOOSTERS

CAS No. GMP grade

cQrex™ AQ (L-Alanyl-L-glutamine) 39537-23-0

cQrex™ GQ (Glycyl-L-glutamine hydrate)

211446-46-7

cQrex™ GY (Glycyl-L-tyrosine dihydrate)

39630-46-1

cQrex™ AAQ (N-Acetyl-L-alanyl- L-glutamine)

121574-43-4

L-Alanyl-L-proline 13485-59-1

cQrex™ Carnosine (β-L-alanyl-L-histidine) 305-84-0

cQrex™ AKG(α-Ketoglutaric acid) 328-50-7

Evonik Nutrition & Care GmbH | cQrex™ cell culture ingredients

L+L 17-01-093 BD Cell Culture_200x287mm_RZ.indd ––– 03. Mai 2017; 12:27 Uhr

Page 11: cQrex cell culture ingredients - Evonik Health Carehealthcare.evonik.com/...Brochure-Cell-Culture.pdf · brochure. Boosters When ... cQrex™ cell culture ingredients from Evonik

This information and all further technical advice are based on our present knowledge and experience. However, it implies no liability or other legal responsibility on our part, including with regard to existing third party intellectual property rights, especially patent rights. In particular, no warranty, whether express or implied, or guarantee of product properties in the legal sense is intended or implied. We reserve the right to make any changes according to technological progress or further developments. The customer is not released from the obligation to conduct careful inspection and testing of incoming goods. Performance of the product described herein should be verified by testing, which should be carried out only by qualified experts in the sole responsibility of a customer. Reference to trade names used by other companies is neither a recommendation, nor does it imply that similar products could not be used. cQrex™ – trademark of Evonik Industries AG and its subsidiaries.

Evonik Nutrition & Care GmbH Health Care Business Line Pharma & Food Ingredients

[email protected] www.evonik.com / cQrex

Evonik Nutrition & Care GmbH | cQrex™ cell culture ingredients

Page 12: cQrex cell culture ingredients - Evonik Health Carehealthcare.evonik.com/...Brochure-Cell-Culture.pdf · brochure. Boosters When ... cQrex™ cell culture ingredients from Evonik

This information and all further technical advice are based on our present knowledge and experience. However, it implies no liability or other legal responsibility on our part, including with regard to existing third party intellectual property rights, especially patent rights. In particular, no warranty, whether express or implied, or guarantee of product properties in the legal sense is intended or implied. We reserve the right to make any changes according to technologi-cal progress or further developments. The customer is not released from the obligation to conduct careful inspection and testing of incoming goods. Performance of the productdescribed herein should be verified by testing, which should be carried out only by qualified experts in the sole responsibility of a customer. Reference to trade names used by other companies is neither a recom-mendation, nor does it imply that similar products could not be used.

cQrex™ – trademark of Evonik Industries AG and its subsidiaries.

EVONIK NUTRITION & CARE GmbH Health Care Business Line Pharma & Food Ingredients

[email protected]/cQrex