HeyJaredEvolution of Virus inactivation methods in manufacture of biologics
Viral contamination is a common threat to all animal- and human-derived biopharmaceuticals. A virus is essentially an infectious agent that is capable of infecting a host cell and to copy itself. Viruses consist of nucleic acid (DNA or RNA) in a protein coat/capsid.
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Optimizing Bioprocess System Lifecycle Management for Long-Term Performance and Regulatory Compliance (opens the original)
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In biopharmaceutical manufacturing, success is not only defined by how well a system performs at installation but also by how consistently it operates over time. Lifecycle management has become a critical aspect of maintaining efficiency, compliance, and product quality in facilities producing sterile-formulations. From initial design and validation to ongoing maintenance and upgrades, a structured lifecycle approach ensures that bioprocess systems continue to meet evolving regulatory and operat
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