CordenPharma

Peptides Platform

Peptides Platform

• Proven track record delivering world class manufacturing services from early stage to commercial supply, including complex products (e.g., Linaclotide, Enfuvirtide, Mifamurtide, Eptifibatide, Glatiramer, GLP analogues), for leading pharmaceutical companies.
• Proprietary process technologies for cost-effective manufacturing and a robust CMC dossier by reducing the number of chemical steps, increasing purity and decreasing raw material costs, while considering green approaches to reduce our carbon footprint impact.
• A unique expertise in Peptides offering access to a wide range of products to meet customer needs.
• Fully-integrated service offering > from APIs to finished dosage and pharmaceutical services (clinical trial kits preparation, randomization and logistics).
• Backward integration for key starting materials > securing the supply chain in terms of costs & quality.
• Multiple manufacturing locations across Europe & the USA offering flexibility of supply while supporting our Business Contingency Plan (BCP).

Platform Description

The CordenPharma Peptides Platform is comprised of Bio-organic Peptide Active Pharmaceutical Ingredients (APIs).

CordenPharma experts manufacture Peptide APIs using solid-phase, solution-phase, and hybrid solid-solution phase technology at all scales. The wide range of downstream processing capabilities, including preparative HPLC purification, benefits manufacturing at any stage of development.

To complete the fully-integrated service offering, CordenPharma supports customers with Fill & Finish and Pharma Packaging / Logistic services (clinical trial kits, randomization & logistics).

Platform Capabilities

Peptide Manufacturing

With streamlined process development, scale-up and large-scale manufacture, CordenPharma’s Peptide expertise is supported by our two cGMP peptide API facilities CordenPharma Colorado (USA) and CordenPharma Brussels (BE). In addition to the GMP facility process development teams and to increase R&D throughput, CordenPharma’s Frankfurt Peptide Centre of Excellence supports all facilities with process design, development and non-GMP synthesis.

CordenPharma’s streamlined process development and scale-up approach is enhanced by equipment design which mimics large-scale production to avoid/limit deviations associated with the equipment engineering. We have designed state-of-the-art equipment to efficiently respond to customer needs at any scale and stage of development, ultimately resulting in cost-effective Peptide manufacturing.

CordenPharma are also recognized experts in:

• Complex Peptides & Peptidomimetics
• Peptide Conjugations (PEGs, Proteins, Lipids, Carbohydrates)
• Cyclic & Multiple Disulfide Bridge Peptides
• Short Peptides (up to 12 residues), often without HPLC purification
• Green Process Design for REACH Regulation Trend & Cosmetic Market (green solvents)
• Innovative engineering approaches to significantly reduce the solvent consumption of the Solid-Phase Peptide Synthesis (SPPS) steps (by up to 60-70%)
• Design of Experiments (DoE) for Peptide Synthesis
• Scale-Up Know-How