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 ...

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 ...

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 ...

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 ...

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 ...

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 ...

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 ...