Quality and Compliance: How Regulation Is Reshaping the Biologic Excipient Market
Excipients may be inactive ingredients, but they are far from unregulated. In biologics, excipient quality directly affects drug safety, and regulators increasingly expect manufacturers to demonstrate control over excipient supply chains, impurities, and performance. These expectations are reshaping the biologic excipient market, pushing suppliers toward higher purity grades, better...
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