Reagents, Tools, and Services for Pharma Manufacturing. GMP Grade Advanced Intermediates, and Customized Solutions

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1 Reagents, Tools, and ervices for Pharma Manufacturing MP rade Advanced Intermediates, and Customized olutions

2 ur Expertise, Your uccess Roche Custom Biotech offers a growing portfolio of generic and customized products and services for Pharma and Biotech processing and applications. Building on decades of biotechnology experience, state-of-the-art facilities and technologies based on Roche expertise we offer high performance and quality combined with supply security. A comprehensive documentation facilitates your submission to regulatory authorities. Table of Contents MycoTL Test: A PCR-based Mycoplasma Detection Kit 3 Recombinant Proteases, MP rade for Use in API Production 4 Liberase Enzymes, MP rade: Leading Performance in Tissue Dissociation 5 Cofactors, luten- and Animal Component-free for Biocatalytic ynthesis 6 Production of recombinant Trypsin: Fraction containers Custom Development and Manufacturing 7 Products are for further processing only. The MycoTL Test is for general laboratory use. ot for use in diagnostic procedures. Trademarks ETLYAE, LIBERAE, and MYCTL are trademarks of Roche. Dispase is a trademark of odo ushei Co., Ltd., Tokyo, Japan. ther product names and trademarks are the property of their respective owners.

3 MycoTL Test: A PCR-based Mycoplasma Detection Kit Release testing approved by the EMA (European Medicines Agency) for several pharmaceutical products. btain rapid results in hours instead of days. Test cellular and non-cellular samples with high sensitivity. Choose a versatile, widely-accepted test kit. Mycoplasmas are frequent causes of contamination in biopharmaceutical production, cell therapy and tissue engineering. Traditional culture-based methods are difficult to interpret and timeconsuming, requiring up to 28 days to complete. The Roche MycoTL Test is a sensitive method for detecting mycoplasma contamination, helping to improve efficiency, quality, and safety in the manufacturing of pharmaceutical and biological products. Approvals with the MycoTL Test In July 2009, the European Medicines Agency (EMA) accepted release testing with the MycoTL Test for a pharmaceutical product from Roche. The Ministry of Health, Labour and Welfare of Japan (MHLW), and the EMA approved the same test concept for pharmaceutical product testing at a global pharmaceutical manufacturer. The MycoTL Test is for for general laboratory use. ot for use in diagnostic procedures. 3

4 Recombinant Proteases, MP rade for Use in API Production Proteases, animal component-free and produced according to cmp guidelines: Recombinant Trypsin, MP rade Recombinant Carboxypeptidase B (reccpb), MP rade Achieve reproducible performance and eliminate the risk of viral and microbial contamination in your final product using these highly pure recombinant proteases (see Figure 1). Both proteases are specifically designed for use as critical raw materials in the production of Active Pharmaceutical Ingredients (API). ur production process is completely animal component-free, fully validated, and fulfills all current ood Manufacturing Practice (cmp) guidelines. mau Minutes Application fields: API production and processing (e.g., insulin production) Vaccine production and processing Detachment of adherent cells (rectrypsin) Cell dissociation (rectrypsin) Peptide mapping (rectrypsin) Peptide and protein sequencing (rectrypsin) MAB processing (reccpb) Figure 1: Purity of recombinant Trypsin in the final formulation (HPLC uperdex 75 analysis). Contact us for more information about other highly purified, animal component-free proteases, such as Endoproteinase LysC, which is suitable for use in insulin manufacturing. 4

5 Liberase Enzymes, MP rade: Leading Performance in Tissue Dissociation Mammalian component-free and produced according to cmp regulations: Liberase Enzyme Blend, Collagenase I and II, eutral Proteases Thermolysin, and entlyase Enzyme btain outstanding performance in cell isolation using a unique, stable Liberase blend, consisting of two proteases (Collagenase I + II) and an additional neutral protease (Thermolysin or entlyase enzyme, a recombinant Dispase). A new manufacturing process, combined with Roche Custom Biotech protease enzyme technology, generates ultrapure second-generation products for increased cell yield and cell viability. These Liberase enzyme blends are manufactured free of any mammalian or avian tissue-derived raw materials. An optimized enzyme fermentation and purification procedure results in high lot-to-lot consistency (see Figure 2). ur high-quality Liberase enzyme blends are available in research grade and products manufactured in compliance with cmp regulations as well as sterile according to Pharmacopoeia. This broad portfolio of Liberase enzymes ensures a smooth transition from research to the application. Human islets isolated using Liberase MTF Application fields: Dissociation of pancreas, adipose tissue, liver, tumors, umbilical cord, and other tissues Human islet, adult stem cell, and hepatocyte isolation Tissue engineering e.g., cartilage Cell detachment and anti-clumping in cell culture (entlyase) mau Thermolysin Collagenase II Collagenase I Ia Minutes Figure 2: HPLC analysis of 3 validation lots of Liberase MP-. The blend with Collagenase I + II and Thermolysin shows very high purity and intactness of the proteases compared to the classical quality. 5

6 Cofactors: luten- and Animal Component-free, for Biocatalytic ynthesis ne of the long-standing challenges in biocatalysis is the need for continuous regeneration of essential cofactors and the availability of bulk quantities of high-quality product that enable a wide range of enzymes to be used in environmentally friendly synthesis of chiral fine chemicals (e.g., pharmaceuticals, cosmetics, and food additives). ur proven cofactors are gluten- and animal component-free, and are available in bulk quantities to make your large-scale enzymatic conversions faster and more reliable. Production according DI I 9001:2008 standard Products manufactured according to current ood Manufactering Practice (cmp) available upon request Proven high purity with high lot-to-lot consistency Large lot sizes with rapid availability Customized filling, labeling, and packaging tailored to your individual requirements Crystalline AD ur portfolio currently includes: AD, free acid, crystallized or lyophilized ADH, disodium salt, food grade ADP, sodium salt, biocatalytic grade ADP, monosodium salt (available soon) H 2 P P H H H H 2 H H -icotinamide-adenine dinucleotide (AD) 6

7 Custom Development and Manufacturing Benefit from Roche experience in pharmaceutical production techniques. ur extensive experience in the development and production of biotech products is always available to you. Take advantage of custom services and new developments designed e.g., for the next generation of therapeutic protein and antibody manufacturing. For application in glycobiotechnology we are currently developing products for an easier and cost effective way of in vitro glycosylation: Transferase enzymes, manufactured under cmp upon request Activated sugars, kilogram-scale Animal component-free ingredients ( e.g., animal component-free sugars as ingredients for high-level culture media) ne-stop solutions ( e.g., transferase enzymes together with the appropriate substrate) Chromatography columns for purification of biosubstances: Preparing the column for large-scale production ur personalized service features: Tailor-made contract manufacturing with an flexible, customer-focused approach (e.g., strategy, scale, specifications, regulatory requirements, time frame, patents) Broad tool box of capabilities and technologies combined with detailed technical advice from Roche experts at all stages of development and production Complete confidentiality via on-disclosure Agreements F M M M lycan structures on amino acid chain M M M F ur dedicated Roche Custom Biotech key account management, located throughout the world, is eager to support your requirements and promptly answer any inquiries and requests. Please feel free to contact our experts. Products are for further processing only. 7

8 Published by Roche Diagnostics mbh andhofer traße Mannheim ermany 2011 Roche Diagnostics. All rights reserved Your Roche Custom Biotech Customer ervice Europe, Middle East, Africa, and Latin America Roche Diagnostics Deutschland mbh andhofer traße Mannheim, ermany Phone Fax United tates Roche Diagnostics Corporation Roche Applied cience 9115 Hague Road P.. Box Indianapolis, I , UA Phone , ext (toll-free) Fax Canada Roche Diagnostics 201, Boulevard Armand-Frappier HV 4A2 Laval, Québec, Canada Phone Fax Japan Roche Diagnostics K.K. Roche Custom Biotech Applied cience 6-1, hiba 2-chome Minato-ku, Tokyo , Japan Phone Fax Asia Pacific Roche Diagnostics Asia Pacific Pte. Ltd. Regional ales and Market Development 298 Tiong Bahru Road # 16-01/06 Central Plaza ingapore, Phone Fax custombiotech.roche.com

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