Process Research and Key Raw Material Sourcing
IND filed in less than one year
Project timeline 4-6 months |
Case Studies
1, 2, 3, 4 |
One of our clients is a large biotech firm. They had in-licensed a drug project from a small biotech firm. The process to manufacture the API was supposed to be an established process on the gram scale, and thus their management expected cGMP material to be ready for testing in 6 months. Cychem secured a CRO who could scale the process up, develop analytical testing methods, and make the first API material under cGMP for toxicity and clinical testing.
Upon checking the client's process, the CRO found that the process was highly variable and not suitable to produce material for the IND filing and clinical testing. Our CRO was able to identify and test an alternative route within 6 weeks. The new route had one less reaction step, and could be readily scaled to kilo quantities. The new process required a starting material (a liquid ketone) which was available from catalog houses. However, the impurity profile consisted of isomeric ketones which carried through to the API and were therefore not acceptable.
Cychem worked with three custom manufacturers who had the potential capabilities, and found that only one had the sufficient distillation capability on a pilot scale to produce the desired purity. They were able to provide the first kilos in time for our CRO to provide the first cGMP API material within the 6-month target date.
After 4 years, the drug is in PIII clinical trials and the process developed by our CRO is still being used. Our manufacturer of the ketone is still the primary supplier of this key intermediate.
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Case Study 4 >> |
