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 ...

HCPs are unwanted impurities requiring removal during manufacturing, but new trehalose technology significantly reduces HCPs ...

Contract development and manufacturing organization (CDMO) Samsung Biologics made a splash at the end of 2025, acquiring ...

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 ...

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 ...

The International Society for Pharmaceutical Engineering (ISPE) has released its ISPE GAMP Guide: Artificial Intelligence. The guide is designed to be compatible with existing frameworks, including ...

Hydrogen peroxide vapor generators provide touchless decontamination that can circumvent problems associated with operators such as incorrect application of cleaning agents during manual disinfection ...

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 ...

Studies of in-use stability and compatibility with administration components are complex because a wide range of conditions and components are used around the world. In addition, limited guidance is ...