by David S. Kahn and Kent H. Kyburz
Volume 6, Issue 1 (Spring 2007)
Key questions for any company planning to build a new facility include processes to be followed for effective design, commissioning, and qualification. Pilot plants need to be flexible, but as flexibility increases, so does complexity and cost. The scope of the new clinical trial pilot plant for bioprocess operations at Eli Lilly and Company (K360) was based on specific technology platforms and extensive benchmarking. Global regulatory issues had to be considered in the design as well because the material it produces will be used worldwide. The K360 plant has the capability to produce mammalian, bacterial, and yeast-based protein and peptide products following typical processes for growth in bioreactors. The protein or peptide of interest is recovered following fermentation and then purified in the facility. The plant’s output is bulk active pharmaceutical ingredient (API)…
Citation:
Kahn DS, Kyburz KH. Design of a Biotech Clinical Trial Manufacturing Facility. BioProcess J, 2007; 6(1): 25-28. http://dx.doi.org/10.12665/J61.Kahn