Solid Phase Peptide Synthesis Capacity Expansion

Edition 1 / September 2018

Author
Dr. Matthieu Giraud
Director, Global Peptides, Lipids & Carbohydrates Platform,
CordenPharma International

Solid Phase Peptide Synthesis Expansion Strengthens Offerings in Brussels & Colorado

Manufacturing of Peptides at CordenPharma Colorado

A growing number of therapeutic peptides in pipeline and therapeutic indication expansions for peptides are the key drivers for capacity expansion by leading CDMOs (Contract Development & Manufacturing Organizations) in the global peptide API market. Although the early peptides were hormones, therapeutic peptides are now being developed for almost every therapeutic category ranging from anti-inflammatory to cancer therapeutics. Furthermore, CDMOs are focusing on internal and external capacity expansion and integration into the pharma supply chain, which ultimately increases contract manufacturing activities for peptide APIs across the globe.

The global peptide API market is estimated to be valued at US $1,700 Million in 2018, and likely to expand at a CAGR of 7.7% over the forecast period (2018–2025) to reach US 2,900 Million by 2025.

CordenPharma has assembled a wealth of experience (over 30 years for our EU site CordenPharma Brussels (BE) and over 20 years for our North American site CordenPharma Colorado (US)) and expertise in the development of peptide manufacturing under the Peptides, Lipids & Carbohydrates Platform, using both LPPS (Liquid Phase Peptide Synthesis) and SPPS (Solid Phase Peptide Synthesis) technologies.

Our Colorado facility, with approximately 250 employees, has grown a strong focus in the development and manufacturing of APIs from laboratory scale to commercialization at tons scale, thanks to our unique large scale SPPS capabilities. CordenPharma Colorado owns the largest SPPS equipment available, which is used in the manufacturing of peptide fragments up to a ton per batch. The purification of the final peptide can be performed at any scale from 5 cm to 100 cm columns, with 100 cm being the largest worldwide high pressure reverse phase column. To avoid the tedious and poor productivity of the final isolation step by lypohilization, their development team gained an unmatched expertise in peptide precipitation that has been successfully transferred to production in commercial products. The site has a long track record in large scale manufacturing, where all potencies including picogram levels can be reached.

CordenPharma Brussels specializes in the development and manufacturing of peptides using both LPPS and SPPS technologies. In the 1980s, nearly all peptides entering clinical development were fewer than 10 amino acids long (Oxytocin 1962, Leuprolin 1984, Octreotide 1988). The average peptide length has increased with each subsequent decade, largely due to improvements in peptide synthesis and manufacturing technology. A broadened range of popular molecular targets, including B class GPCRs that are activated by larger peptide ligands, has also played a role. Development candidates are more equally distributed in the various length ranges up to 40 amino acids, meaning that they are mostly being produced by SPPS. To follow the market dynamic and better support our customers, CordenPharma is investing in expanded capabilities in CordenPharma Brussels by increasing its SPPS capacity with automated equipment. CordenPharma facilities are regularly inspected by all major regulatory agencies and routinely supply to all regulated markets.

With an integrated network of multiple cGMP manufacturing facilities across Europe and North America, and a unique combined expertise in Peptides, Carbohydrates & synthetic Lipids leveraging our deep pharma legacy, CordenPharma provides access to a wide range of products in a full vertical offering, from back integration of early intermediates and large scale API production to finished dosage Drug Product development & manufacturing.