CMC Development
Combining smart peptide science and flexible manufacturing capabilities conform GMP
Your New Chemical Entity (NCE) peptide projects has changing needs and requirements when it proceeds in CMC development. We assist you in progressing your peptide project through the various stages of development towards clinical application and commercialization.
Our employees are closely involved in the challenges of our customers and go that extra mile to consistently ensure in-time delivery of results and products. The lean processes and structures we have in place meet pharmaceutical industry standards and gives us the agility to make your NCE project into a success story.
Key benefits of working with Pepscan as your CMO include:
- With our strong track-record and flexible Good Manufacturing Practice (GMP)-conform manufacturing capabilities, we can enable you to start your project with confidence.
- 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) and stability testing
- When a peptide development program progresses successfully, at some point large(r) quantities of certain peptides will be required to advance a project to the next phase in development. To address this need, Pepscan offers an upscaling service.
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. Dedicated and experienced peptide specialists meet your needs by drafting a customized synthesis plan that will be executed in our small-scale facility in Lelystad, the Netherlands. We tailor peptides to your needs and specifications, ensuring through streamlined project management and strict procedures conform GMP rapid and high-quality peptide manufacturing.
At the start, every project undergoes a rigorous, though quick, 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.
Pepscan offers GMP-compliant synthesis services for peptide NCEs and commercial peptides. In Lelystad, processes are tailored to your peptide(s), optimized and scaled up. The resulting drug substances are fully suitable for use in clinical trials Phase 1 and 2 (according to EudraLex, volume 4, part II). For Phase 3 and commercial supply, we produce in an FDA/Swissmedic-inspected plant in Switzerland.
Portfolio and specialties
Our portfolio of clients ranges from new innovative scale-up companies to established large pharma companies. We have a proven track record, 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
Pepscan has a proven track record in the field of radiopharmaceuticals and synthesized precursors for radiolabeled peptides suitable for a wide range of applications, lipidated peptides and antimicrobial peptides.
