Stéphane Bancel, CEO of vaccine maker Moderna, addressed shareholders in a letter that dissected the events of 2025 while projecting a positive outlook for the company’s future in 2026 and beyond.
Contract development and manufacturing organization (CDMO) Samsung Biologics made a splash at the end of 2025, acquiring ...
Figure 1A: Antibody–drug conjugate (ADC) structure and delivery pathways; linker chemistry determines the mechanism by which cytotoxin release occurs. This schematic shows a monoclonal antibody (MAb) ...
Biologics such as monoclonal antibodies (mAbs), other recombinant proteins, and viral vectors now represent a major class of pharmaceuticals. Their manufacturing, based primarily on mammalian-cell ...
The application of plant-based systems to produce biopharmaceuticals for human and veterinary indications is a rapidly expanding field. Available systems range from stable transgenic root-cell culture ...
Ionizing-technology–based industries are growing rapidly around the world. The expansion is driven mostly by the technology’s myriad applications, including polymer crosslinking, medical device ...
Minute virus of mice (MVM) was the model virus used for this study. (HTTPS://COMMONS.WIKIMEDIA.ORG). During virus filtration, fouling typically is caused by the presence of protein aggregates, ...
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 ...
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, ...
Graphical Abstract: We developed a mechanistic model to simulate purification of a viral-protein complex by cation-exchange chromatography on the “wrong side” of the molecule’s isoelectric point (in a ...
Figure 1: Hierarchical model schematic; information from all base-level models is communicated to a top-level model through their respective matrices (T j) into a consensus matrix R. R is used to ...
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 ...
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