GMP Grade Advanced Intermediates, and Customized Solutions

Reagents, Tools, and Services
for Pharma Manufacturing
GMP Grade Advanced Intermediates, and
Customized Solutions
Our Expertise, Your Success
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
Production of recombinant Trypsin:
Fraction containers
MycoTOOL Test:
A PCR-based Mycoplasma Detection Kit
3
Recombinant Proteases, GMP Grade
for Use in API Production
4
Liberase Enzymes, GMP Grade:
Leading Performance in Tissue Dissociation
5
Cofactors, Gluten- and Animal Component-free
for Biocatalytic Synthesis
6
Custom Development and Manufacturing
7
Products are for further processing only.
The MycoTOOL Test is for general laboratory use. Not for use in diagnostic procedures.
Trademarks
GENTLYASE, LIBERASE, and MYCOTOOL are trademarks of Roche.
Dispase is a trademark of Godo Sushei Co., Ltd., Tokyo, Japan.
Other product names and trademarks are the property of their respective owners.
MycoTOOL Test: A PCR-based Mycoplasma Detection Kit
Release testing approved by the EMA (European
­Medicines Agency) for several pharmaceutical
products.
Obtain 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 MycoTOOL 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 MycoTOOL Test
In July 2009, the European Medicines Agency
(EMA) accepted release testing with the
MycoTOOL 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 MycoTOOL Test is for for general laboratory use.
Not for use in diagnostic procedures.
3
Recombinant Proteases, GMP Grade
for Use in API Production
Proteases, animal component-free and produced
according to cGMP guidelines:
Recombinant Trypsin, GMP Grade
Recombinant Carboxypeptidase B (recCpB), GMP Grade
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). Our production process is
completely animal component-free, fully validated,
and fulfills all current Good Manufacturing Practice
(cGMP) guidelines.
Application fields:
1400 1200 mAU
1000 800 600 400 200 0 0
5
10
15
20
Minutes
25
30
35
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 Superdex 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
Liberase Enzymes, GMP Grade:
Leading Performance in Tissue Dissociation
Mammalian component-free and produced
according to cGMP regulations:
Liberase Enzyme Blend,
Collagenase I and II,
Neutral Proteases Thermolysin, and
Gentlyase Enzyme
Obtain 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 Gentlyase 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).
Our high-quality Liberase enzyme blends are
available in research grade and products manu­
factured in compliance with cGMP 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:
30 Thermolysin
25 Collagenase II
Collagenase I
20 15 10 mAU
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
(Gentlyase)
5 0 Ia
-5 -10 -15 -20 0
2
4
6
8
10
12
14
16
18
20
22
Minutes
Figure 2: HPLC analysis of 3 validation lots of
Liberase MNP-S. The blend with Collagenase I + II and
Thermolysin shows very high purity and intactness of the
proteases compared to the classical quality.
5
Cofactors: Gluten- and Animal Component-free,
for Biocatalytic Synthesis
One 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., pharma­
ceuticals, cosmetics, and food additives).
Our 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 DIN ISO 9001:2008
standard
Products manufactured according to current
Good Manufactering Practice (cGMP) 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
Our portfolio currently includes:
Crystalline NAD
NH2
O P O P O
O
O
N
O
O

OH
O
N
N
N
OH OH
NH2
O
N
OH OH
6
-Nicotinamide-adenine dinucleotide (NAD)
NAD, free acid, crystallized or lyophilized
NADH, disodium salt, food grade
NADP, sodium salt, biocatalytic grade
NADP, monosodium salt (available soon)
Custom Development and Manufacturing
Benefit from Roche experience in pharmaceutical
production techniques.
Our 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 cGMP
upon request
Activated sugars, kilogram-scale
Animal component-free ingredients (e.g., animal
component-free sugars as ingredients for
high-level culture media)
One-stop solutions (e.g., transferase enzymes
together with the appropriate substrate)
Chromatography columns for purification of biosubstances:
Preparing the column for large-scale production
Our 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 Non-Disclosure
Agreements
N
F
N N
G
S
S
S
S
S
G
G
G
G
N
N
N
M
M
N
G
S
M N
G
N
N
G
S
M
M
G
S
N
M
N
N
F
Glycan structures on amino acid chain
Our 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
Published by
Roche Diagnostics GmbH
Sandhofer Straße 116
68305 Mannheim
Germany
© 2011 Roche Diagnostics. All rights reserved.
06480136990  0211
Your Roche Custom Biotech Customer Service
Europe, Middle East, Africa,
and Latin America
Roche Diagnostics Deutschland GmbH
Sandhofer Straße 116
68305 Mannheim, Germany
Phone +49 621 759 8580
Fax
+49 621 759 8610
[email protected]
United States
Roche Diagnostics Corporation
Roche Applied Science
9115 Hague Road
P.O. Box 50414
Indianapolis, IN 46250-0414, USA
Phone +1 800 428 5433, ext. 14649 (toll-free)
Fax
+1 317 521 4065
[email protected]
Canada
Roche Diagnostics
201, Boulevard Armand-Frappier
HV 4A2 Laval, Québec, Canada
Phone +1 450 686 7050
Fax
+1 450 686 7012
[email protected]
Japan
Roche Diagnostics K.K.
Roche Custom Biotech
Applied Science
6-1, Shiba 2-chome
Minato-ku, Tokyo 105-0014, Japan
Phone +81 3 5443 5285
Fax
+81 3 5443 7934
[email protected]
Asia Pacific
Roche Diagnostics Asia Pacific Pte. Ltd.
Regional Sales and Market Development
298 Tiong Bahru Road
# 16-01/06 Central Plaza
Singapore, 168730
Phone +65 6371 6638
Fax
+65 6371 6601
[email protected]
custombiotech.roche.com