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India Host Cell Protein Testing: Ensuring Biopharmaceutical Quality
Host cell protein (HCP) testing is an essential part of biopharmaceutical production, ensuring the purity and safety of biologic drugs. In India, the growing biopharmaceutical industry has driven a rising demand for advanced HCP testing solutions. These tests detect residual proteins from host cells used in recombinant drug manufacturing, as their presence can impact drug safety and efficacy.
Indian biotech firms and contract research organizations (CROs) are increasingly adopting enzyme-linked immunosorbent assays (ELISA) and mass spectrometry-based HCP analysis. These methods provide precise quantification and identification of impurities, ensuring compliance with international regulatory standards.
Government initiatives promoting biotechnology, along with growing export demand for biologics, have spurred investment in high-quality analytical infrastructure. Local laboratories are expanding capabilities through collaborations with global reference labs and adoption of validated testing kits.
As India strengthens its position in the global biologics market, robust HCP testing practices are crucial for maintaining quality and regulatory acceptance.…