GMP Peptides

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. 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 clinical trial into a success story.

Key benefits of working with Pepscan as your CMO include:

  • With our strong track-record and flexible GMP-conform manufacturing capabilities, we can enable you to start your first or second phase clinical trial 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)
  • 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. 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 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, 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.

Stability testing

To support you in your preparations for IMPD or IND filing we offer as an additional service to deliver a CMC report. This report includes all the technical details related to your product. We also offer to test your product’s stability. We are experienced in stability testing, using our qualified equipment, according to the Q1A principles of the ICH guidelines. Data on new drug substances’ stability is a crucial part of the dossier needed to take the next step in filing for IMPD or IND.

Our portfolio

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

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.

To find out more about our clinical peptide synthesis or request a quote, contact us.

 

Zoran Medić - Business Development Manager Biopharma