Traditional formulations commonly struggle to achieve content uniformity with morphologically challenging active pharmaceutical ingredients (APIs), requiring the use of complicated processes such as ...
Explore the complexities of gene and cell therapy development with our comprehensive guide to Chemistry, Manufacturing, and Controls (CMC) testing. Learn how our expertise ensures the safety, potency, ...
Spray drying enables the production of amorphous solid dispersions, allowing efficient scale-up from small screening batches to commercial levels. By leveraging small-scale experiments for process ...
Stay compliant with Annex 1 for early phase sterile fill finish processes. Discover how to implement robust contamination control strategies, integrate isolator technology, and conduct integrity ...
Elevate your viral screening with Eurofins BioPharma Product Testing’s qPCR- based assays. Our advanced testing goes beyond standard screenings to detect even dormant and hard-to-detect pathogens, ...
In this episode of the Ask the Expert video series, Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Siegfried Schmitt, vice president, Technical at Parexel, discuss ...
In this episode of Drug Digest, industry experts discuss their experiences in dealing with the challenges of developing and manufacturing next-generation biotherapeutics. They also discuss their ...
Application of Validation Principles to the Training Quality System: Part 9, Quality Risk Management Hazard Identification ...
Application of Validation Principles to the Training Quality System: Part 9, Quality Risk Management Hazard Identification ...
Application of Validation Principles to the Training Quality System: Part 9, Quality Risk Management Hazard Identification ...
Application of Validation Principles to the Training Quality System: Part 9, Quality Risk Management Hazard Identification ...
Application of Validation Principles to the Training Quality System: Part 9, Quality Risk Management Hazard Identification ...
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