Drug Substance manufacturing scale-up and first GMP production
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Summary
The project focused on the scale-up and manufacturing of a lead molecule’s Drug Substance (DS) to support initial clinical development. It involved overseeing the optimization, scale-up, and successful manufacturing of non-GMP batches (2-5 kg) for pre-clinical toxicology studies. The culmination of the project was the successful manufacturing of the first 6 kg GMP batch. This step secured the required quality material for the clinical trial and demonstrated the scalability and control over the manufacturing process.
Oversight of DS program development and optimization
Manufacturing of non-GMP batches for pre-clinical studies
Successful scale-up to pilot and GMP production
Review of the manufacturing's control strategy
Coordination of manufacturing at a CDMO
QA check of the manufacturing documentation
Delivery of the company’s first 6 kg GMP batch
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Marek Cichocki
Founder
20 years of experience in the pharmaceutical industry.
