Case Study: Protocol Design for a Temperature-Sensitive Biologic
Designing a stability protocol for a temperature-sensitive biologic drug requires a nuanced approach, integrating regulatory expectations, product-specific vulnerabilities, and real-world distribution challenges. In this case study, we examine the development of a customized stability protocol for a recombinant monoclonal antibody (mAb) intended for subcutaneous administration, with known sensitivity to temperature excursions and mechanical agitation. This…
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