CordenPharma's Early-Phase Peptide Centre of Excellence
Products
Information
In addition to the largest worldwide capacity of commercial SPPS peptide production up to batch sizes exceeding 400 kg (> 35 Amino Acids), and a yearly capacity of > 2 Metric Tons of Peptide, CordenPharma's multi-pronged approach to becoming the #1 peptide CDMO supplier extends to small-scale capabilities, which started with expansions of non-GMP peptide capacity back in Q4 2020. Now CordenPharma's Peptide Centre of Excellence in Frankfurt, Germany is in the process of adding GMP manufacturing capacity to serve early-phase customers with first-in-human supplies. The manufacturing line, which started construction at the end of 2022, will be available in H1 2024 and will consist of: • 2 SPPS lines, 1 cleavage line and 1 liquid-phase reactor • Downstream process capabilities including HPLC, concentration equipment (thin film, nanofiltration), and isolation equipment (filter & freeze dryer) • Clean room concept and utilities The manufacturing area will be supported by a new fully-fitted QC laboratory that will support API release and stability studies. This fully compliant area will receive local authority approval in Q2 2024, and will accommodate production up to kg scale supporting customers' regulated toxicology studies, Phase 1 human clinical trials, and Phase 2 resupply batches. This newly built capacity, together with CordenPharma's well-established injectable Fill and Finish services at CordenPharma Caponago, Italy, will jointly launch a unique, fully-integrated Drug Substance / Drug Product peptide offering in Q4 2023. Customers targeting First-In-Human clinical trials will be fully supported - from end of discovery phase to first GMP clinical supply - with a customized approach directed by experts in peptide chemistry, formulation, and CMC preparation and strategy. We believe this end-to-end approach will increase our customers' chance of success in their IND submission, all while minimizing their time to clinical trial.
