CASE STUDY:
Development and GMP Manufacture of an Anti-Cancer Peptide Conjugate

Challenge

Accomplishment

Why Cedarburg Hauser was Selected

• The scientific expertise related to conjugating peptides to potent compounds.
• The scientific expertise with potent compounds required to successfully complete the challenging process chemistry, optimization and scale-up.
• The appropriate training and laboratory controls for safe handling of the potent materials.

Details

Cedarburg Hauser was initially contracted to optimize the client’s research-stage synthetic reactions up to the 100g scale and provide material for the clients research use.  As a result of a successful outcome in initial scale-up chemistry the client chose to commission Cedarburg Hauser for further process development and cGMP manufacture.   

The process optimization of the conjugate API required the development of a preparative reverse phase HPLC protocol that initially relied upon a very expensive chromatographic resin.  Although acceptable quality product could be reproducibly isolated, the purification required frequent resin changes and the historical overall process yield was only 45-50%.  

Cedarburg Hauser initially produced 200g quantities under cGMP using the initial purification process.  Through careful study, Cedarburg Hauser scientists were able to identify and optimize key chromatographic parameters that resulted in an improved separation, a significantly increased resin life, and an overall process yield increase to 65-70%.   The conjugate API was delivered on schedule and exceeded the customer requested amount by >10%.  Scale of the chemistry has been increased to excess of 600g per batch and chromatography to > 200 g per batch.

Cedarburg Hauser’s analytical team also developed and qualified methods to monitor both reaction progress and intermediates ensuring a high purity for the final API and performed successful full release testing.  Additionally, our quality assurance team monitored and released the final API to the custody of the client. Lastly, the methods developed by Cedarburg Hauser were stability indicating and the customer chose to conduct product stability studies to ensure acceptable product quality.

FIND OUT MORE ABOUT THE KEY SERVICES, AREAS OF EXPERTISE AND TECHNOLOGIES WE USED TO DELIVER A SUCCESSFUL OUTCOME FOR OUR CLIENT