Peptide APIs

Peptide APIs

GMP Process
Peptide therapeutics have emerged as an increasingly important area of research as they offer high selectivity, efficacy, and specificity compared to traditional small molecule drugs. Currently, there are > 60 peptide approved drugs on the market along with > 400 peptides drugs in various stages of clinical development.

CEM & AmbioPharm’s partnership allows for an ideal production of Peptide based API’s. Using CEM’s unique microwave peptide synthesis technology, production processes for peptide NCE’s can rapidly be developed. Additionally, cost effective production processes can be developed for generic peptides as well. AmbioPharm’s U.S. based Manufacturing site has completed US FDA Inspections and can support production of the simplest to most complex peptide NCE’s.

Rapid Development of Production Process for Peptide New Chemical Entities

Rapid Development of Production Process for Peptide New Chemical Entities
  • Extremely rapid process optimization times
  • Production efficiencies from a higher synthesis quality

CEM’s Microwave SPPS Technology makes synthesis of peptides much easier and faster. Rapid optimization of the manufacturing process takes place at small scale and is easily transferred to Production Scale. The unique process generally leads to higher purities with more efficient use and selection of reagents. Additionally, higher purities result in an easier purification process.

A Microwave Assisted cGMP-Ready Process for Eptifibatide

Learn More about CEM’s Unique SPPS Technology
Improve Existing Production Processes for Generic Peptides

Improve Existing Production Processes for Peptide APIs
  • CEM’s Microwave SPPS Technology Improves Synthesis
  • AmbioPharm’s Cost Efficient Manufacturing and Raw Material Supply

An improved production process for established Peptide APIs reduces the cost of drug production which is clearly beneficial. CEM’s Microwave SPPS Technology makes synthesis of peptides much easier and faster. Additionally, AmbioPharm’s access to raw materials and solvent recovery systems further reduces manufacturing costs. The result is an ideal combination of technologies for optimizing production processes for peptide manufacturing.