Cedarburg Hauser has a proven track record developing and manufacturing complex APIs. We have successfully worked with our clients on a variety of projects including API conjugates, prostaglandins, natural products and pharmaceutical intermediates.
The confidential nature of our business prevents us from disclosing all of the details of these projects, however, we can share the type of work we did and the overall achievements help give a sense of our track record of success. Please take a moment to review these case histories and then contact us to discuss your project.
A cost-effective and industrially scalable process for the GMP manufacturing of exemestane was developed by scientist at Cedarburg Hauser. The resulting process is scalable from grams to 100+ kg and improved overall yield from < 30% in the patent literature to 48-52%. The purity of the API was also improved from 90-99% in the patent literature to 98-102%, meeting ICH guidelines.
Cedarburg Hauser successfully developed, optimized, scaled and manufactured a potent, controlled substance polymeric conjugate API. Working closely with our client we were able to meet their aggressive timeline and generate 1.3 kg of the target API conjugate under GMP conditions. The material was high purity and the final optimized process produced an overall yield of 52%.
Cedarburg Hauser successfully produced a peptide conjugate API under GMP conditions at 25 times the scale achieved prior to our involvement, providing enough material for our client’s phase II clinical trial. We were also able to develop a second conjugate for toxicology studies, phase I clinical trials and reference standards.
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%.
Other Case Studies
Process Transfer and Optimization for an Anti-Cancer Agent
New Process Development for the Flavor Industry
New Process Development for a Commercial Prostaglandin
Enhancement and Isolation Process Development of a Natural Product