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The discussion in this Drug Digest video focuses on optimizing biopharmaceutical manufacturing and supply chain efficiency through the mastering of AI capabilities, data integration, and critical validation challenges.

ADC oncology platforms, FDA CNPV rapid review, and significant investment into US biologics manufacturing capacity led this week’s news.

The transformative impact of complex biopharmaceuticals hinges on integrating advanced delivery systems, often accelerated by AI modeling, with robust manufacturing practices and regulatory alignment to ensure stability, safety, and effective patient access.

David Dodd, GeoVax Labs, opines on why vaccine platform diversity is critical in the United States.

Samsung Life Science Fund’s investment in Phrontline Biopharma highlights growing industry momentum behind dual-payload ADCs.

AstraZeneca’s $2 billion investment in its Maryland facilities will expand domestic biologics and rare disease manufacturing and strengthen US drug supply chains.

Five bio/pharma sector leaders dissect FDA’s CNPV pilot program.

Progress in vaccine development is closely tied to advancements in biopharmaceutical technologies, regulatory landscapes, and quality assurance methodologies.

News in the week shows biopharma development being redefined by programmable biology and accelerated FDA review, stressing quality compliance and market efficiency.

Five leaders from across the bio/pharma sector explore the opportunities and challenges posed by FDA’s CNPV pilot program.

Microfluidic rapid-testing advances enhance real-time QC, strengthen compliance, and speed contamination detection across modern biomanufacturing.

Sapient said the workflow will allow for direct measurement of more than 10,000 protein groups in a single, 5-µm slide.

In this episode of the Ask the Expert video series, Susan J. Schniepp, Regulatory Compliance Associates (RCA), Siegfried Schmitt, Parexel, and Anita Michaels, RCA, explain how CDMOs can best handle regulatory inspections and client expectations.