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This whitepaper examines peptide crystallization scale-up from a CMC perspective, with emphasis on how early crystallization hits are translated into controlled, reproducible processes. Using NPH insulin as a case study, it highlights the importance of solid-form definition, nucleation control, crystal growth, isolation behavior, and product-quality attributes. The discussion frames peptide crystallization not as a simple lab success, but as a process-development challenge that directly influences manufacturability and product performance.
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