Tag: <span>regulatory considerations</span>

From the Editor-in-Chief: Applying More Automation to Our BioProcessing

As an industry, we need to do far more to implement technologies and work with FDA, not only to keep them informed, but to make sure they are aware of industry trends and newer technologies. Remember that CBER and
CDER have their own labs, and in many cases, they will want to bring in the technologies you want to use and see how they work in their own experiments…

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Biologics Production

biologics bioproduction FDA in-process automation in-process testing new technologies pat process analytical technologies process monitoring regulatory considerations reproducibility

Regulatory and Monetary Drivers for Real-Time Analytics

Implementation of “real-time” analytics (RTA) in processes for biologics is challenging from a technological and timeline perspective. Therefore, there need to be significant drivers from both a regulatory (quality) and a monetary standpoint to justify investment. Understanding how regulatory agencies define real-time analytics and the expectations for implementations (how and when) is a key component to rational decision-making, and dovetailing process improvement and facility design is important in the planning and development process…

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Biologics Production Cell & Gene Therapy Cell Lines Mammalian Cell Culture Manufacturing Regulatory Viral Reference Materials Viral Vectors

at-line analytics biolgics design space biologics cpp critical process parameters design-of-experiments doe fda guidance fmea in-line analytics ind investigational new drug mabs monoclonal antibodies on-line analytics pat process analytical technology real-time analytics regulatory considerations rta