SB3000’s Chief R&D Officer has advocated on behalf of the company’s continuous manufacturing technology
Speaking at the ‘Innovative Chemistry for Peptide Manufacturing and Analysis’ conference, SB3000’s Chief R&D Officer Jens Bukrinski argued the company’s continuous manufacturing μLOT technology could reduce the pharmaceutical industry’s use of toxic chemicals by as much as 100 times.
Batch manufacturing has long been the standard for peptide pharmaceutical manufacturing, but it is hugely inefficient, SB3000 says, requiring massive facilities and vast quantities of toxic raw materials. Peptide manufacture is one of the most wasteful and least green chemical processes, and peptide synthesis is almost universally carried out in toxic solvents, the company says. Typically, more than 4000 kg of solvents are required to produce just one kilo of drug.
SB3000 says its μLOT continuous manufacturing enabling technology uses a chemical production line which can be constantly monitored in real time, uses just a tenth of the solvent required in batch processing.
The FDA is actively encouraging a move to continuous manufacturing in the pharma industry. It’s said continuous manufacturing will reduce drug shortages, minimise batch manufacturing scale-up issues, and enable shorter process times, improve quality control, generate smaller footprints, and increased flexibility in scale.
Bukrinski said during his presentation: “μLOT allows for continuous manufacturing of peptides at large scale, with hugely reduced environmental impact. For example, liraglutideiii is currently manufactured as a recombinant peptide in yeast. If manufactured synthetically with current batch SPPS it would generate 16,000 tons of toxic waste per year. Switching to continuous manufacturing using μLOT would cut toxic waste by 100 times to just 160 tons toxic waste per year.”