As the FDA signals stronger support for advancing gene therapy approvals, manufacturers face increasing pressure to get to market quickly while maintaining viral vector quality. This article tackles emerging scale-up challenges to efficiency and safety, with an in-depth look at strategies to optimize viral vector production, manage costs, and collaborate on industry standardization and automation.
Top 10 Cleanroom Problems That Can Be Prevented via Preventative Maintenance (May 2025)
May 16th 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.
Optimizing cGMP Facility Design Space with a Hybrid Approach (May 2025)
May 16th 2025In this webcast, we review industry drivers and risks for capital construction, with a focus on cleanroom infrastructure, and discuss the goals of using a hybrid approach while demonstrating its application and benefits using real-world examples.