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CordenPharma Frankfurt Receives GMP Certification for Early to Mid-Stage Clinical Peptide Manufacturing

News
16 Jan 25

(CordenPharma Photo) CordenPharma Frankfurt Managing Director Dr. Karsten Meyenberg speaks to employees in the new GMP-certified peptide manufacturing area.

CordenPharma is pleased to announce that on 15 January 2025, our CordenPharma Frankfurt, Germany site successfully received GMP certification from the German Regulatory Authority Hessisches Landesamt für Gesundheit und Pflege (HLfGP)!

The GMP certificate comes after a 14 November 2024 inauguration celebration of the newly expanded facility, and represents an important milestone reflecting the exceptional quality of our work, the unwavering dedication of our team, and our commitment to providing innovative solutions in peptide development and manufacturing.

The state-of-the-art facility is purpose-built to support early- to mid-stage peptide development and clinical supply projects, specifically targeting Phase I and Phase II clinical programs, by providing cutting-edge technologies and a valuable track record of analytical method development & validation for efficient progression through clinical trials to commercialization.

(CordenPharma Photo) CEO Dr. Michael Quirmbach and CordenPharma Frankfurt Managing Director Dr. Karsten Meyenberg join the team at the site’s GMP inauguration celebration on 14 November 2024.

Highlights of the GMP-Certified facility include:

  • State-of-the-art GMP peptide manufacturing suites to meet the highest quality and regulatory standards.
  • Enhanced capacity for peptide development and small to mid-scale manufacturing, enabling accelerated timelines.
  • Seamless synergy across our facility network from small to large-scale peptide drug substance manufacturing, with integrated supply support for injectable drug product development & manufacturing tailored for IND/IMPD submissions.
  • Commitment to innovation, efficiency, and sustainability in supporting complex drug development.

This GMP certification positions the Frankfurt site as a vital asset for supporting customers’ early- to mid-stage clinical demands efficiently and swiftly, and through an internal process transfer to our large-scale site in Colorado, ensures a streamlined supply from early stage to commercialization.

Fully integrated with ongoing large-scale peptide expansions in Europe and Boulder, Colorado, the GMP-certified site also leverages forward integration with our robust Lipid NanoParticle (LNP) GMP manufacturing, Oral Solid Dosage peptide development, and broad capabilities in sterile injectable development and manufacturing, driving forward our commitment to providing seamless solutions across the pharma supply chain.

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