Process Chemistry

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The work of the Process Chemistry de partment at the Merck Frosst Centre for Therapeutic Research begins when basic research has identified a potential new drug candidate. The mission of the synthetic organic chemists in the department is to discover the ideal synthesis of the chemical entity, taking into account factors such as safety, environmental considerations, yield and cost-effectiveness. As the drug development process unfolds, many departments within Merck Research will require supplies of bulk drug. It is the responsibility of Process Chemistry to discover, design and develop a chemical synthesis that can meet these ever increasing supply demands.

Fulfillment of this mission involves investigating and choosing an appropriate synthetic pathway and gaining an in-depth understanding of the chemical reactions and work-up parameters of the process. The identification of key parameters enables the process to be streamlined to maximize the yield and quality of the product.

Once development of the process is completed at bench scale (grams), it is scaled up in our preparative laboratory facilities to produce between 1 and 5 kg of bulk drug for use in safety and clinical studies.

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If results look promising in these initial studies, the synthetic process is refined and optimized further, in conjunction with engineering specialists, to ensure that the compound is suitable for pilot plant scale production (100s of kg) or factory scale production (1000s of kg).