Peptide-to-Injectable FIH Clinical Supply

Presented by Dr. Mimoun Ayoub, Global Head Peptides Platform, and Dr. John Cameron, Global Head Injectables Platform.

Key Video Takeaways for Peptide Drug Substance to Injectable Drug Product for FIH Clinical Supply

Challenges in Transitioning to First-in-Human (FIH) Trials: Innovators face hurdles such as scaling peptide API synthesis to GMP standards, synchronizing Drug Substance and Drug Product production, meeting CMC and regulatory requirements, and accessing injectable formulation technologies.
Importance of Speed: Rapid entry into Phase 1 trials offers strategic, financial, and scientific advantages by accelerating milestones, conserving resources, and securing competitive positioning.
Integrated Solutions for Speed & Risk Reduction: CordenPharma enables parallel development of peptide APIs and Injectable Drug Products, provides a single CDMO contract, and leverages a global network for streamlined tech transfers and guaranteed Drug Product slots.
Expanded Capacity & Technology: Purpose-built GMP facilities in Frankfurt, Plankstadt, and Caponago offer advanced peptide development, aseptic filling lines, expanded formulation labs, and continuity into late-stage supply.
Comprehensive Project & Regulatory Support: A single accountable project lead manages global execution, while CordenPharma assists with CMC strategy and regulatory documentation for both APIs and Drug Product.