Practical Guide: Mastering Process Validation and Quality Control to Produce Products that Scale from Clinic to Commercial
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Process validation is essential in biopharmaceutical drug production to ensure product consistency, safety, and quality at every clinical stage, and to effectively reach commercial approval. It minimizes risks, reduces costs, and facilitates a smoother transition from earlier clinical stages to large-scale production, ensuring that drugs are made efficiently safe and effective for patients.
Ensuring Biologic Stability with Tailored and Cutting-Edge Lyophilization Solutions
April 14th 2025Explore how tailored lyophilization solutions, integrated with quality-by- design principles and advanced modeling, help optimize stability, reduce costs, and enhance global accessibility for biopharmaceuticals.
Top 10 Cleanroom Problems That Can Be Prevented via Preventative Maintenance
April 14th 2025Cleanrooms require strict environmental control to maintain sterility, prevent contamination, and ensure seamless operations. Without a proactive preventative maintenance (PM) program, various issues can arise, leading to costly downtime, contamination risks, and operational inefficiencies. Below are ten common cleanroom problems that can be effectively mitigated through proper PM practices.
