Drug development and production rely on stringent quality controls, reproducibility, and verification. Biopharmaceuticals, including protein-based therapie



Summary

Drug development and production demand rigorous quality controls, reproducibility, and verification. Biopharmaceuticals, particularly protein-based therapies, face unique challenges due to their complex structures and biological sources. Analytical testing ensures identity, purity, potency, and safety throughout the manufacturing process. These tests cover everything from raw materials to final product release and require sophisticated instrumentation and techniques. Maintaining consistency batch-to-batch and ensuring patient safety are paramount. Consequently, analytical testing is crucial for regulatory compliance and overall success in biopharmaceutical development and manufacturing.

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