CordenPharma Peptides, Oligonucleotides, Lipids 
& Carbohydrates Platform

Your Expert Partner for Bio-Organic APIs

Platform Manager
Dr. Mimoun Ayoub
Director, Global Peptides, Oligonucleotides, Lipids, Carbohydrates & Injectables Platforms, 
CordenPharma International
  • Proven track record delivering world class manufacturing services from early stage to commercial supply, including complex products (e.g., Linaclotide, Enfuvirtide, Mifamurtide, Eptifibatide, Glatiramer), 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.
  • A unique combined expertise in Peptides, Oligonucleotides, Carbohydrates and synthetic Lipids, offering access to a wide range of products, including conjugates, 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.

Platform Description

The CordenPharma Peptides, Oligonucleotides, Lipids & Carbohydrates Platform is comprised of Bio-organic APIs & Excipients (Oligonucleotides, Peptides, Lipids & Carbohydrates). CordenPharma experts manufacture Peptide APIs using solid-phase, solution-phase, and hybrid solid-solution phase technology at all scales. The wide range of down-stream processing capabilities, including preparative HPLC purification at any scale, benefits oligonucleotide manufacturing at any stage of development. CordenPharma is additionally well-known for expertise in synthetic Lipid and Carbohydrate manufacturing. 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 three cGMP peptide API facilities: CordenPharma Colorado (USA), CordenPharma Brussels (BE), CordenPharma Switzerland (CH). In addition to the GMP facility process development teams and to increase the R&D throughput, CordenPharma’s Frankfurt, Germany R&D Center supports all facilities with process design, development and non-GMP synthesis.

CordenPharma’s stream-lined 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.

CordenPharma is also recognized as an expert in:
  • Pegylated Peptides
  • GLP-1 Peptides & Long Peptide Sequences
  • Cyclic Peptides; Peptides with multiple (up to 4) disulfide bridges
  • Fatty Acid & Carbohydrate Conjugated Peptides
  • Arginine-rich Peptides
  • Peptide Mimetic Synthesis
  • Short Peptides (up to 12 residues), often with no preparative HPLC purification

Oligonucleotide Manufacturing

Leveraging decades of experience in peptide manufacturing with the existing wide range of downstream capabilities at multiple facilities, CordenPharma Colorado offers Oligonucleotide process development, scale-up and cGMP manufacturing at multiple scales, supporting early stage to Phase II / III, (with commercial supply expected by the end of 2017).
 
  • Process Development & Small-scale > scale-up to 10 mmol per run (small-scale equipment can also support early-stage supply)
  • Scale-up and Small to Medium-scale > scale up to 60 mmol per run (supported by OligoPilot 400 equipment)
  • Oligonucleotide Process Equipment >  allows fully-automated manufacturing at a scale-up to 1800 mmol per batch
  • Downstream Processing Capabilities > For each of the above mentioned process stages, multiple sets are available for streamlined and cost-effective manufacturing

Lipid Manufacturing

CordenPharma is a well-known expert in synthetic Lipid process development, scale-up and large scale manufacturing, including custom lipids and standard lipids (Glycero-Phospholipids, Sphingolipids, Cationic Lipids), for which CordenPharma holds several Drug Master Files (DMFs).
 
CordenPharma supports customers’ needs for Custom Lipids as Drug Delivery Systems (e.g., oligonucleotide drug delivery) or as APIs. Over the past several years CordenPharma has developed substantial expertise in Custom Lipid Synthesis (particularly in cationic lipids manufacturing). These lipid manufacturing services complement our offering of oligonucleotide API and Drug Product services.

Carbohydrate Manufacturing

CordenPharma has gained extensive experience in complex Carbohydrate synthesis, including but not limited to Carbohydrate-based Vaccines and Carbohydrate Conjugates for Receptor Targeting (such as siRNA drug delivery to various tissues). Most of these complex building blocks are available from inventory, which allows for quick delivery.

Facilities Included in Platform