As manufacturing processes become increasingly complex and decentralized, there are likely to be more stages where bulk freezing of drug substances could benefit product stability, quality, and overall process efficiency.
Freezing drug substance after or during production is done to slow chemical/biological degradation and preserve stability. Freezing also restricts microbial growth, extends the shelf-life, and prevents contamination from extractables and leachables by limiting exposure of drug to its container.
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