Products

Examples of successful API development and cGMP manufacturing projects I have delivered working as group leader within a pharmaceutical CDMO setting.

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Anti-cancer drug product

Drug substance – cGMP – Phase I – 9-kg scale

The goal of this fixed-price project was to transfer and optimize a low-yielding, kilogram-scale cGMP process to enable the scalable production of a more stable salt form of the drug substance. Through my optimization efforts, I succeeded in doubling the overall yield of the chemical process and producing and releasing the amount of drug substance requested by the client. En route, I effectively overcame intrinsic quality issues related to the appearance of black-particles and nitrosamine contamination in the drug substance. I also characterized a previously unknown incompatibility between the drug substance and one of the process solvents, successfully modifying the chemical process to mitigate the risk to the final batch quality. Finally, I optimized a key palladium scavenging process replacing an expensive polymer-based palladium scavenger with inexpensive and more scalable L-cysteine. The result was a 100-fold reduction in the residual Pd content to within the <10 ppm target in the released batch with a corresponding 10-fold saving in the chemical costs for that specific step. Beside my role as project lead, I also wrote and led the negotiations for all signed, process and manufacturing-related proposals and work orders associated with this project.

COVID-19 vaccine

cGMP starting materials – Phase I – 300-mg scale (per peptide)

The goal of this project was to supply eight 14-mer peptides (Target: 400-mg/peptide) for the in-house cGMP manufacture of an experimental (Phase I) COVID-19 vaccine. Initially, I produced non-cGMP batches of each peptide in sufficient quantity (100 mg-scale) and quality high-quality (>92 a/a% purity; highest single impurity <2a/a%) from the development work to enable the production of a successful non-GMP technical batch of the COVID-19 vaccine. Under tight production timelines, my team managed to overcome a number of unforeseen setbacks during production to produce and release sufficient quantities of each cGMP peptide (150-350 mg) within four months of the start of the development work. This ensured the on-time delivery of these GMP starting materials for the successful production of the cGMP batch of the COVID-19 vaccine. Beside my role as project lead, I also drove production in the lab working beside a lab chemist, and wrote and led the negotiations for all signed, process and manufacturing-related proposals and work orders associated with this project.

Peptides for personalized medicine

Drug substances – cGMP – Phase I – 50-mg scale (per peptide)

The goal of this fixed-price program was the on-demand supply of cGMP libraries of synthetic, anti-cancer peptides to critically ill cancer patients for an ongoing clinical trial. In view of the patients’ critical state, production timelines were extremely short emphasizing the need for right-first time manufacturing. Ultimately, two cGMP campaigns were successfully delivered on time, each time according to the pre-agreed timelines. Beside my role as project lead, I also drove production in the laboratory working beside a lab chemist, and wrote and led the negotiations for all signed, process and manufacturing-related proposals associated with this project.

Immunomodulatory cell therapy

Drug substance – cGMP – Phase I – 25-g scale

The goal of this fixed-price project was the supply of an aliquoted, cGMP-grade drug substance for a Phase I clinical study. This project was noteworthy for it’s small scale and extremely short timelines. The entire project, from development work through to the released material, was achieved on time, according to the pre-agreed three-month pre-agreed timeline and within budget.

API route scouting

Drug substance – discovery – lab-scale

The goal of this fixed-price project was the development of a new, patentable synthetic route to a known, commercial steroidal drug. A senior bench chemist from a different team developed the initial scouting route based on routes disclosed in the patent literature. My team then successfully completed this initial route. In the next phase, my team optimized the initial route, resulting in a doubling of the overall yield, a reduction in the total number of synthetic steps by two steps, and the discovery of a new, patentable route. Beside my role as project lead, I also wrote the signed work-order for the optimized route.