BioPharm International - October 2021

BioPharm-October 2021-Regulatory-Sourcebook

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18 BioPharm International eBook October 2021 Selecting the Right CMC Strategy for Biologics Smaller biopharma companies must do due diligence with their CMC strategy for BLA filings. O nce a biopharmaceutical company discovers a novel biologic, advancing it from the bench to the bedside is a complex and arduous process. While clinical trials make up a sig- nificant portion of the cost and complexity of clinical development, an equally critical and multifarious component of a biomanufacturer's investigational new drug application (IND) or biologics license application (BLA) is its chemistry, manufacturing, and control (CMC) strategy. CMC involves a series of plans, tests, audits, and reports that describe the compound in question, its manufactur- ing process, and the manufacturing facility in which it is made. In an IND or BLA, a manufacturer must define the methods for manufacturing and administering the com- pound as well as characterize the product's chemical and therapeutic properties. In addition, the manufacturer must establish a strong, reliable, and effective product testing protocol for stability testing and forced degradation testing, for instance, and describe the design, qualification, opera- tion, and maintenance of their manufacturing and support facilities. In fact, these CMC processes require so much effort to produce that companies will often develop one or more strategies that they can apply to various product pipe- lines to bring drugs to the market efficiently. Because there is no one-size-fits-all approach to CMC, the strategy is often tailored to each compound's specific platform and method of delivery. This is especially true for biologics, including those for rare disease or personalized medicine, because each one is unique to the indication and often involves a shortened development timeline. KHANH NGO COURTNEY, PhD, is senior director of Biologics, Avomeen. KHANH NGO COURTNEY Regulatory Sourcebook CMC Strategies PESHKOVA - STOCK.ADOBE.COM

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