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 ...
HCPs are unwanted impurities requiring removal during manufacturing, but new trehalose technology significantly reduces HCPs ...
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) ...
Ion-exchange chromatography (IEC) is a common method for oligonucleotide purification (1, 2). Separation by IEC often uses strong–anion-exchange (AEX) resins at moderate to strongly basic pH values. A ...
A biosimilar biotherapeutic product is similar (but not identical) in terms of quality, safety, and efficacy to an already licensed reference product. Unlike generic small molecules, it is difficult ...
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 ...
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 ...
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, ...
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 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 ...
A digital twin (DT) is a theoretical representation or virtual simulation of an object or system composed of a computer model and real-time data (1). A DT model operates upon information received from ...
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