Genetic Engineering & Biotechnology News

JUL 2017

Genetic Engineering & Biotechnology News (GEN) is the world's most widely read biotech publication. It provides the R&D community with critical information on the tools, technologies, and trends that drive the biotech industry.

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Genetic Engineering & Biotechnology News | GENengnews.com | JULY 2017 | 29 required will not only increase proportionally with the increased scale of vector manufactur- ing, but also, the associated quality require- ments will be increased, moving from materi- als made to "traceable" standards to those made to GMP-grade standards (Figure 2). For early-phase development, non-GMP-grade plasmids may be used for the production of material for proof-of principle clinical studies. However, this may not be the case for com- mercial vectors, where GMP-grade plasmids may be required. One consequence of this will be the potential need for manufacturers to align with suppliers that have large-scale GMP capabilities to ensure the timely and se- cure delivery of plasmid supplies to support late clinical and commercial production. At the end of the supply chain is the pro- duction of the viral vector drug product. For early-stage development, relatively little fo- cus is given to either the product formulation or the filling process. There is often good reason for this, as material for such develop- ment studies is in very short supply, with all available material often directed into clinical studies to demonstrate product efficacy. The result of this is that the basic formu- lations used in early-stage development are carried forward into late-stage trials, with the products 0.2-µm filtered and hand filled into glass vials and stored at –80°C. Future development activities in the AAV field will need to be focused on identifying formulations that provide long-term stabil- ity, potentially moving to +2–8°C storage, and generating meaningful stability data. Fully defining the drug product manufactur- ing process will also ensure the retention of product titers and activity throughout the manufacturing process, including activities such as inspection and labeling. In conclusion, we are in exciting times with a number of these potentially life-changing products coming through to clinic. However, if we are to bring these products efficiently to the market, developers will need to adopt pragmatic and informed solutions for the manufacturing challenges that lie ahead. Bioprocessing Tony Hitchcock is technical director at Cobra Biologics. Website: www.cobrabio.com. Tutorial CHEMICAL GLYCOSYLATION OF PEPTIDES BACHEM Bachem and GlyTech, Inc. Two pioneers in their respective fields collaborating to advance innovation in drug development. ADVANTAGES OF CHEMICAL GLYCOSYLATION • Homogeneous products: chemical synthesis yields well-defined glycopeptides • Most chemically synthesized peptide drugs can be easily adapted to glycosylation • Competitive production costs OH OH H 3 C H 3 C OH OH OH OH OH OH HO NH NH HO HO O O O O O O O O O Improving the Pharmacokinetic Profile of Drugs MORE THAN 50 GLYCANS ARE AVAILABLE www.bachem.com GENengnews.com

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