PEPTIDE NCES
With over 50 years of expertise in peptides, a track record in process development, large-scale manufacturing and outstanding product quality we are the leading partner in tides.
Bachem’s arsenal of industry-leading talent, cutting-edge equipment and historical legacy enables us to offer a full range of integrated services to bring our partner’s breakthroughs to market.
WHAT BACHEM OFFERS
We produce research grade peptides as well as GMP-grade material, from simple peptides to the most complex peptidomimetics or synthetic proteins. Our pipeline of customer peptide NCE projects includes both analytical services and process development:
Analytical services
- Product characterization
- Development and validation of analytical methods
- Stability studies
- Identification of impurities
Process development, characterization and qualification
- For all phases of clinical trials
- Commercial supply
A clear plan for developing the Chemistry, Manufacturing, and Control (CMC), of peptide and oligonucleotide drug substances, affords our partners a risk-mitigated approach to any clinical and commercial milestones. Our interactions with regulatory authorities and sponsors around the world lends itself to a general plan (below), which is custom-tailored to every project.
Innovation is part of our DNA and is more important now than ever, as it’s common to see modified or augmented peptide constructs. Peptides with unnatural amino acids, PEGylation, lipidation, glycosylation, imaging agents and structural constraint, are only a few examples of what we encounter with today’s peptide-based entities.
Bachem strives for innovation by optimizing our supply chain, manufacturing unnatural amino acid derivatives in-house, and meticulous characterization at intermediate stages. We also carefully evaluate peptide synthesis methodology; including liquid phase peptide synthesis, solid phase peptide synthesis, or hybrid approaches.
Modern synthetic innovations like Molecular Hiving™, or downstream innovations like continuous chromatography, and an overall green-conscious process, are examples of pioneering commercial manufacturing technology for peptides, which Bachem is proud to have in our toolbox.
It’s only getting better at Bachem – with a research committee dedicated to evaluating the newest trends and technologies, and collaborating with academic groups and industry non-profits, rest assured that our customers have access to the latest and great in peptides.
The Bachem facilities are regularly inspected and approved by national and international regulatory authorities like FDA, Swissmedic and others and we have available our certificates of GMP compliance, licenses and other documents.
