But cell and gene therapies (CGTs) are catching up. During Cell and Gene Therapy International Europe 2025, held in Berlin, ...
Contract development and manufacturing organization (CDMO) Rentschler Biopharma has announced a partnership with ...
Stéphane Bancel, CEO of vaccine maker Moderna, addressed shareholders in a letter that dissected the events of 2025 while ...
Contract development and manufacturing organization (CDMO) Samsung Biologics made a splash at the end of 2025, acquiring ...
HCPs are unwanted impurities requiring removal during manufacturing, but new trehalose technology significantly reduces HCPs ...
The biopharmaceutical industry is at the forefront of technological advancements, with “biopharma 4.0” revolutionizing the way biomanufacturing is conducted (1). The concept combines automation, ...
AntiD (trinbelimab, BSV Bioscience) prefilled syringe with safety device. Prefilled syringes (PFSs) are an optimal method of delivering biologics because they provide for easy administration, decrease ...
The 2011 process validation (PV) guidance document from the US Food and Drug Administration (FDA) states that the number of samples used for PV “should be adequate to provide sufficient statistical ...
Regulatory agencies increasingly are adopting risk-based inspection strategies to ensure that biological products meet stringent safety, efficacy, and quality standards. US Food and Drug ...
The concept of an analytical lifecycle has been well received in the biopharmaceutical industry. In 2016, the US Pharmacopeia (USP) advocated for lifecycle management of analytical procedures (1) and ...
Components of a cell-free protein synthesis reaction (extract, supplements, and a DNA template) with the key reactions that occur when they are combined A growing area in which CFS platforms are ...
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