Through this acquisition, the German CDMO expands its global network and adds aseptic fill/finish and lyophilization expertise to its sterile manufacturing capabilities.
Elizabeth Hickman (Chief Business Officer, AustinPx) explains the company's approach to improving bioavailability, ...
Brian Feth and Jonathan Grinstein go behind the headlines to discuss the impact of a Republican administration on Federal ...
Traditional formulations commonly struggle to achieve content uniformity with morphologically challenging active pharmaceutical ingredients (APIs), requiring the use of complicated processes such as ...
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 ...
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 ...
Direct-to-patient (DTP) clinical supply services provide sponsors and patients with enhanced supply chain flexibility. Traditionally, clinical supplies are shipped to clinical sites where patient kits ...
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 ...
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, ...
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 ...
CDER Director Patrizia Cavazzoni and CBER Director Peter Marks provided an update on the rare disease innovation hub in a new FDA Voices blog post.
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