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Manufacture Contract Manufacturing Services, Standards & Regulation, Bioprocessing - Single Use Systems

When Standardization Meets Customization

sponsored by Pall Biotech

Figure 1: A 3-D representation of Pall Biotech's Gene Therapy platform in the Pall Solution Builder environment.

Pharmaceutical companies can spend upwards of $2 billion developing a drug (1), but by the time it is ready to be commercialized, more than half of its patent exclusivity period is likely to have elapsed. When you also consider that only a small minority of the Phase I drugs reach the commercial scale (around 14 percent) (2), companies must take full advantage of their marketable drugs to recover their investment costs – this means getting to market as quickly as possible upon receiving Phase III approval. 

An important factor in maximizing speed to market is scale up. During Phase II and III studies, companies will be manufacturing small quantities of clinical material and, typically, using equipment that will not support anticipated drug demand during commercialization. Scaling a bioprocess to accommodate larger flow rates and higher output volumes can be a lengthy and sometimes difficult task. Many of the challenges are as a result of making trade-offs between the availability of fundamental technologies (such as instrumentation, pumps and tubing) and optimally operating processing equipment within their designed ranges – this can be a fine (and time consuming) balance. 

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About the Author

Jeremy Rautenbach

Global Product Manager for Integrated Solutions at Pall Biotech.

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