Author Archives: Kenneth Clapp

Process economy and production capacity: Comparing single-use and stainless steel strategies for microbial fermentation

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In recent years, single-use technology has been migrating into many unit operations.  With the commercial availability of such systems end users have a new option for process development and production that does not rely on operational complexities and utility requirements of conventional sterilize-in-place (SIP) or autoclavable systems. However, just as for cell culture processes, single-use technology may not apply to each and every fermentation or microbial process.  It is the responsibility of practitioners to properly assess their own applications, select…

December 9, 2015

A Faster, Flexible Alternative to Conventional Outsourcing for Biologics

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          For many developers of new biologics, outsourcing clinical or commercial manufacturing with a contract manufacturing organization (CMO) makes good sense. Dozens of capable CMOs offer ready capacity to companies who can’t afford the time, capital or risk involved in building their own biomanufacturing capacity. Of course, the convenience of instant access to a CMO’s infrastructure comes at a steep price: Many CMOs use proprietary cell lines, media, and other technology that will limit a drug…

August 1, 2011

Rapid Optimization of Single-Use Bioreactor Performance

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          Whether evaluating conventional stainless steel or single-use bioreactors, every system must accomplish the same thing: control a bioprocess for an intended result. The result may be biomass, product titer, substrate conversion, or any number of complex, process-specific productivity measures. Each system shares the same basic elements, including a bioreactor vessel and a gas addition subsystem. The vessel uses an agitation subassembly, gas sparger, and in some cases, gas overlay elements. These must be properly engineered…

July 1, 2010