NCE Peptides

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 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) and stability testing
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.

Our facility, which includes GMP-graded cleanrooms, allows us to manufacture APIs, from milligram to gram quantities.

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

 

Zoran Medić - Business Development Manager Biopharma

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