Wednesday, August 13, 2008 - 11:00 AM
S116

Contract fermntation checklist : 100,000+ liter scale

Flint Harding III, Corporate Development, Martek Biosciences Inc., 1416 N. Williamsburg County Hwy., PO Box 5000, Kingstree, SC 29556

Martek Bioscience’s Kingstree, SC  fermentation plant has been involved with contract manufacturing projects since 1994.   During this time the operations staff developed and refined versions of a “check list” or “start report”  which was used to facilitate the technical transfer and define responsibilities between plant operations and clients.   The checklist covered a wide variety of topics related to contract manufacturing such as process safety, regualtory requirements,  laboratory testing, raw material procurement,  process technical transfer,  and final product packaging and labeling. The talk will focus on a few items which particularly related to large scale fermentation and will also serve to as an introduction other talks in the “Challenges and Solutions in Large Scale Fermentation” session overall.