By Bachem AG
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Bachem becomes global innovator in large-scale peptide production
Bubendorf, Switzerland: – Peptide technology specialist Bachem AG has become a leading global innovator in the science of industrial-scale peptide production, harnessing several revolutionary technologies.
This innovation reflects the potential of peptides and oligonucleotides to expand the range of conditions that can be targeted with drugs, leading to them becoming increasingly in demand for investigation in clinical trials or in therapeutic products. In turn, this has created need to produce ‘tides ever more efficiently and cost-effectively.
Breaking through barriers
Large-scale manufacturing of ’tide-based active pharmaceutical ingredients (APIs) faces many technological challenges, ranging from decreasing yields when synthesizing molecules with more building blocks to the sustainability issues involved in using enormous quantities of solvents for synthesis and purification.
Bachem has determined to make chemical production of APIs more efficient and sustainable by applying new solutions to all steps of the manufacturing processes, either as process optimizations or in step-change new technologies.
Automation of SPPS
Implementation of new level of automation and digitalization of solid-phase peptide synthesis (SPPS) to meet the predicted rise in demand for capacity and compliance.
This automation has realized numerous benefits such as increased capacities through more flexible, reliable, and scalable manufacturing processes, higher quality APIs with improved ‘first-time right’ rates, optimized equipment usage, reduced operating times, paperless documentation, simplified GMP compliance, and improved data security and integrity.
This new technology allows fewer washing and filtration steps when compared to classic peptide synthesis, allowing production of shorter peptides without hazardous solvents, with more efficient scale-up and enhanced process controls and resulting in a reduction of up to 60% in the use of organic solvents.
This CMR free process can synthesize peptides without the use of DMF, NMP, or any other hazardous solvents and reagents, with fewer equivalents of Fmoc amino acid derivatives and coupling reagents required. It also allows direct in-process control via HPLC liquid chromatography or other methods.
Chemo-enzymatic Peptide Synthesis (CEPS)
Bachem is collaborating with EnzyTag to investigate applications for CEPS that involves using peptiligase enzymes as a scalable alternative for the large-scale manufacturing of larger linear peptides with more than 40 amino acids or even the production of small proteins. This is also a more economical manufacturing method for cyclic peptide drugs and (bio)conjugates.
CEPS technology can enable regio- and stereoselective synthesis of peptides that cannot be efficiently manufactured in conventional SPPS steps. Protection of side-chain functionalities is not necessary, as side reactions and racemization are absent.
Multi-column Countercurrent Solvent Gradient Purification (MCSGP)
Incorporation of MCSGP into the downstream process helps to overcome the bottleneck of the enormous amounts of solvents involved in the production of peptides and oligonucleotides. Bachem has set up the first continuous chromatography system for center-cut purification of peptides and oligonucleotides at industrial scale.
Compared to single-column batch purification, solvent consumption is typically decreased by over 30%, thus contributing to a higher level of sustainability. The process has a higher capacity and often reaches the target product purity often with a higher yield, typically 10% more.
Towards Green Chemistry
Along with CEPS and Molecular Hiving™, MCSGP is a significant step towards green chemistry and also increases the capacity, quality, and sustainability of the purification process in a scalable way that is particularly useful for large-scale production. It can also run 24/7 under automated control, significantly decreasing purification campaign cycle times.
Bachem is a leading, innovation-driven company specializing in the development and manufacture of peptides and oligonucleotides. The company, which has over 50 years of experience and expertise, provides products for research, clinical development, and commercial application to pharmaceutical and biotechnology companies worldwide and offers a comprehensive range of services.
Bachem operates internationally with headquarters in Switzerland and locations in Europe, the US and Asia. The company is listed on the SIX Swiss Exchange.
For further information, see www.bachem.com.
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