Pharmaceutical R&D

The Clinical Supplies department at the Merck Frosst Centre for Therapeutic Research prepares experimental dosage forms of all new drug candidates discovered in the Research Centre, to support clinical trials of the drug in humans. Thus it is an integral part of the entire drug development process. Closely linked with the Formulation and Process Development group, Clinical Supplies is where process scale-up takes place. The knowledge and experience gained in preparing these experimental dosage forms is part of the technology transfer that takes place from research to manufacturing in the run up to the launch of a new drug.

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Clinical Supplies comprises two functional groups: manufacturing and packaging, which work together to supply clinical studies being conducted worldwide. Manufacturing takes over from the work of the formulation development team, and produces batches of experimental dosage forms on a pilot scale according to the standards of good manufacturing practices (GMP). The packaging operation can be viewed as the first crucial step in the clinical trials of a potential drug: supplies must be correctly packaged according to the protocol of each study, generally in a blinded fashion, before being shipped to their destination.

Preparing clinical trial supplies can present interesting challenges. Early Phase I trials involve small numbers of patients and small batches of drug. As the development program moves into Phase III, the number of patients can exceed 10,000 and the Clinical Supplies team needs to produce significantly larger batches of drug. Because of this, the manufacturing process is constantly evolving and scale-up issues need to be addressed. The group also has the challenge of developing and producing the matching placebos required to conduct blinded studies. Packaging for blinded studies requires precise methodology and a wide range of approaches, from bottles to blister cards, to mixed product allocations. Each patient kit assembled by Clinical Supplies is unique-assigned and distributed to one specific patient who could be located anywhere in the world.

Clinical supply activities continue long after the launch of a new drug. SINGULAIR® (montelukast sodium) developed here at Merck Frosst and currently marketed worldwide, still represent about 50% of the clinical supply effort in the form of post-marketing trials, and the development of new indications and new formulations.

Throughout the drug development program Clinical Supplies not only provides the product needed to carry out each clinical study, but also establishes the link between product development and clinical research that is essential for drug approval.

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