Combining smart peptide science and flexible manufacturing capabilities conform GMP
From early R&D to clinical peptides supply, Pepscan’s team of experts is passionate about devising a customized synthesis plan to meet your needs. We assist you in progressing your peptide project through the various stages of development towards clinical application and commercialization. The drive for excellence and our state-of-the-art facilities ensures we consistently deliver high-quality results on time and within budget.
Key benefits of working with Pepscan include:
- Short timelines for the different phases of production conform GMP due to flexible in-house peptide expertise
- A best practice template for process, analytical methods and documentation greatly reduces development efforts and time
- Synthesis protocols that are fully optimized by experts in peptide chemistry during a (non-released) pilot batch project
- A range of different analyses under GMP (e.g. H2O, residual solvents (ACN/TFA, etc.), peptide content)
- A full range of peptides services, from peptide discovery, lead optimization, R&D production up to clinical API production (clinical phase 1 & 2).
Scientific and operational excellence
Pepscan employs some of the industry’s finest chemists capable of applying their expertise in the fields of peptide synthesis, scaling up and analysis. We tailor peptides to your needs and specifications, ensuring through streamlined project management and strict procedures conform GMP rapid and high-quality clinical peptide manufacturing.
At the start, every project undergoes a rigorous process research and development analysis. Once we have identified what we believe is the optimal process, we review the detailed plan in consultation with you and your team. As additional service, we deliver a CMC report that can be used for IMPD/IND filing.
Our facility in the Netherlands, which includes a GMP-graded cleanroom, allows us to manufacture clinical API’s, from milligram to gram quantities. For kilogram scale, Pepscan has established an integrated supply chain alliance with a leading European partner.
Our portfolio of clients ranges from new innovative scale-up companies to established large pharma companies. We have a proven track record in producing clinical peptides for use in Phase I and II trials conform to GMP standards, including:
- Production scale ranging from mg-scale up to (multi)gram-scale.
- Step-wise multiple disulfide bond formation
- Incorporation of non-natural building blocks
- Peptide (fluorescent) labelling