cqrex cell culture ingredients - evonik health...
Post on 05-May-2018
242 Views
Preview:
TRANSCRIPT
cQrex™ cell culture ingredientsfor research, manufacturing and clinical applications
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
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.
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
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
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
■ 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: cQrex@evonik.com
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
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
cQrex@evonik.com 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: cQrex@evonik.com. 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
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
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
cQrex@evonik.com www.evonik.com / cQrex
Evonik Nutrition & Care GmbH | cQrex™ cell culture ingredients
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
cQrex@evonik.comwww.evonik.com/cQrex
top related