A fermentation process for the manufacture of virus like
particles (VLPs) in Escherichia coli (E. coli) was transferred
from an external collaborator and rapidly implemented in
Pfizer's cGMP pilot plant. Challenges faced in the transfer were
meeting the high oxygen demand of the original process, and
attempting high density cultivation of E. coli in a bioreactor
system primarily designed as a seed tank for larger-scale
mammalian and microbial culture. These concerns were overcome by
an approach that combined process and equipment
characterization, allowing suitable adaptation of the process to
fit the pilot facility. Technology transfer of manufacturing
processes for recombinant proteins frequently involves the
reassessment of equipment capabilities and corresponding process
requirements. In this context, this article describes the
transfer of a fermentation process for the manufacture of Q-beta
virus like particles (VLPs) in Escherichia coli (E. coli) from
an external collaborator to Pfizer's cGMP pilot plan