Contract development and manufacturing organization (CDMO) Abzena has announced the formation of a strategic partnership with ...

What seems certain is that space and low-orbit laboratories will become an integral tool for drug innovation within the ...

Contract development and manufacturing organization (CDMO) Matica Biotechnology has partnered with Calidi Biotherapeutics to ...

Biomanufacturing outsourcing growth is slowing, but political uncertainties, tariffs, and labor shortages are reshaping where ...

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 ...

Gene-therapy firm Klotho Neurosciences announced that it is preparing to manufacture KLTO-202 for upcoming clinical trials. KLTO-202 is an RNA splice variant developed to treat Amyotrophic Lateral ...

Here we explore the objectives and significance of material risk assessments, classify raw materials by risk profile, and investigate critical risk categories, including microbial contamination and ...

Bristol Myers Squibb (BMS) and BioNTech have announced a strategic partnership to codevelop and commercialize BNT327, a bispecific antibody candidate indicated for multiple solid tumor types. BMS will ...

Planning for commercial biologic manufacturing is challenging, not least because it requires considerable time, investment, and economic risk. As global demand for biopharmaceuticals climbs, drug ...

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