APRIL 202519CHEMICAL INDUSTRY REVIEWCOMPLEXITIES IN THE DEVELOPMENT PROCESS FOR PHARMACEUTICAL MANUFACTURINGBy Erik Lemay, Head of Global External Manufacturing, ServierCXO INSIGHTSThe pharmaceutical manufacturing process is extremely complex, comprising numerous steps from raw material acquisition, active pharmaceutical ingredient (API) synthesis, formulation, packaging, and distribution. At each stage, rigorous quality control measures are employed to ensure the product's integrity and even more critically, patient safety.At Servier, we are committed to ensuring all our products meet the highest standards of quality, safety, and efficacy for the patients we serve. We offer a full range of drug substance and drug product manufacturing, development, and packaging services for distribution in the U.S. and worldwide. We recently enhanced our supply chain organization to meet the increasing complexity driven by the development of our product portfolio, with many new fixed dose combinations and new flows and supplies. Our research and development in oncology, one of our core therapeutic areas, is concentrated on hard-to-treat cancers, including glioma, or brain tumors, as well as hematologic and pediatric cancers. In the case of glioma, manufacturing brain-penetrant oncology treatments presents unique challenges due to the complex nature of both cancer therapeutics and the biological barriers that protect the brain. One example is vorasidenib, Servier's investigational oral, selective, and brain-penetrant dual inhibitor of mutant IDH1 and IDH2 enzymes for the potential treatment of low-grade glioma, where therapeutic progress has been stagnant for decades. Due to accelerated clinical trial enrollment and proof of efficacy, Servier is working fast to determine filing timelines and availability of clinical supply. The formulation of vorasidenib is complex, and in order to ensure that the product meets the highest quality, safety, and efficacy standards, it is critical we have a series of safety and performance tests in place throughout the supply chain process. Our supply chain organization is fully integrated into Servier, with multiple partners across business development, manufacturing, distribution, clinical and commercial partners, and global operations. This ensures a high level of regulatory and safety compliance across the global Servier network, as well as efficiencies that provide reductions in cost and time to market.Erik Lemay is the Global Head of External Manufacturing for Servier and is responsible for the end-to-end delivery of Servier's global portfolio of products that are manufactured at CMO partners. Erik Lemay
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