The update to EU GMP Annex 1 offers market opportunities in aseptic operations, focusing on compliance with new standards. Key areas include contamination control, cleanroom design, and advanced ...
Manufacturers are usually subjected to a diverse variety of regulations typically established by international and regional bodies. Failure to comply can result in the loss of authorization and ...
Cell and Gene Therapy (CGT) emerged as a potential treatment for blood-based cancers via the FDA’s accelerated approval process. However, CGT was quickly reined in even as it heralded a wave of ...
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