Introduction: The Strange Mirror of Biopharma and Food Biopharma has long viewed itself as the high temple of fermentation. From the earliest recombinant insulin made in E. coli to monoclonal antibodies expressed in CHO cells, the industry has prided itself on scientific rigor, regulatory discipline, and painstaking optimization. Each bioreactor is treated like a cathedral of sterility […]
Tag: GRAS
Beyond E. coli: Unlocking Non-Traditional Hosts in Biologics Manufacturing
Introduction: Why “Beyond E. coli” Matters For decades, E. coli has been the undisputed workhorse of microbial biomanufacturing. From recombinant insulin in the 1980s to a vast array of enzymes, antibody fragments, and research proteins, E. coli has set the standard for scalability, cost efficiency, and genetic tractability. Yet as the biologics landscape becomes increasingly complex—spanning full-length antibodies, […]
Harnessing Bacillus as a Manufacturing Platform: A CDMO Perspective
Among microbial expression hosts, Bacillus has carved out a unique niche in biomanufacturing. Unlike Gram-negative bacteria such as E. coli, Bacillus subtilis and related species are naturally endotoxin-free, simplifying downstream purification and expanding their appeal for therapeutic proteins, enzymes, and next-generation biologics. For a Contract Development and Manufacturing Organization (CDMO), mastery of Bacillus systems requires balancing its advantages—secretion capability, GRAS status, industrial […]