“Maximizing Value from Strain and Process Development for Production of Pharmaceuticals” was the title of a presentation given by Dr. Reinhardt Rosson at the Global Pharma R&D Summit. Designed to be both a technical and a business partnering meeting, the Summit was held at the Anaheim Marriott, October 23-25, 2006. Dr. Rosson spoke on the morning of October 24th. His presentation focused on how implementation of non-cGMP fermentation and recovery development programs could be used in the development of pharmaceuticals. It could be especially useful for companies with limited resources. An abstract of the presentation appears below.
Fermentation and recovery process development outside the constraints of cGMP can be an effective tool within the greater framework of cGMP product manufacture. Outsourcing these early phases of process development can lead to high-yield, lower-cost processes at the hands of experienced project teams focused on, and dedicated to, your project. Bio-Technical Resources assembles experienced project teams to move client projects quickly through these initial development stages, transfer the technology to the client's manufacturing site or CMO, and support scale-in and scale-up within the site's cGMP framework. Examples of successful programs for the microbial production of antibiotics, steroids and proteins will be described.
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