Company: BioMarin Pharmaceuticals
Liaison(s): Kim Fellows-Peake
BioMarin Pharmaceutical Inc., of Novato, California, develops, manufactures and commercializes biopharmaceuticals for the treatment of rare diseases. BioMarin has successfully launched four products and is actively engaged in joint ventures and partnerships. With commercial operations in over forty countries and a robust clinical pipeline, BioMarin is a key player in the rare (orphan) disease market, providing access to treatments for patients with historically unmet medical needs. Cold chain refers to a temperature-regulated supply chain, encompassing storage, handling, shipping, and distribution activities. Cold chain is a fast-growing part of the healthcare logistics industry, and providers are adapting to meet the ever-changing regulatory demands. In addition, biotechnology companies ship high-value and temperature sensitive products, often in experimental or developmental phases of clinical trials, the latter comprising the majority of industry costs. Cold chain compliance, although a non-revenue generating activity, is essential to the operation of modern biotechnology companies. Currently, BioMarin has a very product-specific approach to the clinical product cold chain and is looking for a template strategy that will provide a consolidated, integrated and up-to-date solution to their cold chain needs. The BioMarin TMP team approached this project in two phases. First, the team determined the current landscape of pharmaceutical cold chain through conference attendance and interviews of subject matter experts, and gathered BioMarin’s requirements for their cold chain. The BioMarin TMP then applied these requirements through a decision matrix of vendor solutions to identify the most appropriate primary and tertiary containers for shipping of bulk clinical products. The project’s second phase focused on qualification testing of the container candidates, analysis of cargo carriers, as well as an examination of commercial cold chain requirements (bulk drug substance and vial shipping). Ultimately, our team provided a comprehensive, commercial-ready list of solutions to meet BioMarin’s cold chain needs for their pipeline products.