CMC Connections explores the strategies, systems, and decisions that define Chemistry, Manufacturing, and Controls across the product lifecycle. This series brings expert insights on regulatory expectations, process development, and scalable manufacturing in the life sciences industry.
Introduction The pharmaceutical industry is witnessing a massive shift from traditional small-molecule drugs to complex large-molecule biologics. Because these therapies are derived from living…
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Raw materials have become one of the fastest-emerging risk factors in modern CMC. As advanced therapies rely on increasingly complex components, variability in critical…
Read more »Navigating CMC Risks, Readiness, and Real-World Manufacturing Challenges The FDA’s new policy to publicly release Complete Response Letters (CRLs) marks a profound shift toward…
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This step-by-step guide explores the critical stages of upstream and downstream processing, regulatory compliance, and the technical hurdles sponsors must navigate to ensure product quality and patient safety."}]
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