What does it take to produce 25 kg of peptide in production equipment?
When production problems are identified early in the lab, bridging development work can be implemented to ensure scalability of a process. Early targeted development with a focus on improving efficiency by lowering costs and streamlining production is necessary to succeed as a project scales up.
With a tight timeline, targeted development was completed after a proof of concept laboratory production of the naturally occurring Type C Natriuretic Peptide, 22-Amino Acid Cys-bridged cyclic peptide (GLSKGCFGLKLDNIGSMSGLGC), to meet production requirements to manufacture 3 kgs in the pilot plant. Development discussion includes: synthetic route selection to meet low cost of goods and scale up issues related to backbone de-aggregation and C-terminal Cysteine racemization, resin cleavage/de-protection reactions to fit plant materials of construction, dilute large scale oxidation folding reactions, purification using two pass chromatography, and isolation issues. Re-classification of the peptide as a health hazardous category 3B compound added additional challenges which were addressed to ensure safe manufacturing.