Pharmaceutical R&D

The Pharmaceutical Research and Development (PR&D) Analytical Laboratory at the Merck Frosst Centre for Therapeutic Research provides analytical support for a new drug, from pre-development, through formulation development, to the filing of regulatory applications worldwide.

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The bio-analytical team, a part of the analytical group, evaluates the bioavailability of the new compound in several animal species, and also the delivery of the drug from formulated solid dosage forms.

The analytical group as a whole develops methods to evaluate formulations during the development phase. The aim is to ensure that these formulations will deliver the drug to the correct biological sites in humans, to produce the necessary effects. These evaluation protocols also ensure the quality of dosage forms undergoing clinical trials.

Another important function of the group is developing stability testing protocols, to support the regulatory dossier for the new chemical entity. When a product is ready for commercial manufacturing, the analytical team transfers these analytical methods to the manufacturing team at the designated Merck Manufacturing Division, to ensure that, ultimately, quality is maintained.

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Automation is used extensively by the PR&D analytical laboratory to maximize the time available for research-based experiments. While automated tablet processing workstations and dissolution testing provide the data needed to document batch equivalency, chemists are encouraged to pursue innovative research. Scientists have access to the most up-to-date HPLCs equipped with the latest detection devices, such as ultraviolet diode array, mass spectrometry, and evaporative light scattering. Other state-of-the-art equipment includes a capillary electrophoresis system, FTIR, colour monitor, particle sizers, and GC equipped with multiple detectors. In addition, the laboratories have recently installed state-of-the-art triple-quadrupole and ion trap MS equipment. Efficient data management is assured by an automated data transport architecture for all analytical instruments.

The Analytical group also participates in the development of innovative formulations, such as new, fast-release dosage forms, dry powder systems, and sprinkle formulations. All these new formulations require analysis to support drug delivery claims. The team also evaluates any special coatings, such as those added to mask taste or designed to release the drug under specific biological conditions, to prove that they remain unchanged in the long term. Analytical laboratory scientists also test new packaging formats to ensure that the packages maintain the integrity of the product.

Innovation is shared with the broader scientific community through academic collaborations. Relationships with the Université de Montréal and the University of British Columbia have proven to be mutually beneficial, and several members of the analytical team hold academic appointments. To keep abreast of current technology, some members also collaborate with high-tech companies to co-develop and evaluate new, state-of-the-art instruments.