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Regulatory Landscape and Quality Assurance


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Challenges and Developments


Additionally, the rise of biologics—therapeutic products derived from biological sources—has necessitated a shift in API production strategies. Biologic APIs require specialized processes and facilities compared to traditional small-molecule APIs, leading many companies to invest in biopharmaceutical capabilities.


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Conclusion


- Regular Monitoring Continuous monitoring of water chemistry is essential. Parameters such as conductivity, pH, and microorganism levels should be regularly checked to assess the need for chemical adjustments.


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