Five Factors to Consider When Scaling Up Biologics Production to Meet Global Commercial Output

Successful biologics production scale-up requires careful attention to five key factors: raw material quality, cost of goods (COGS), manufacturing footprint, regulatory landscape, and supply chain unpredictability. This article delves into the challenges of maintaining product consistency, managing costs, and securing regulatory approvals while ensuring uninterrupted raw material supply. It offers practical insights into process modifications, outsourcing strategies, and risk management techniques to achieve efficient scale-up.

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