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 ...

AntiD (trinbelimab, BSV Bioscience) prefilled syringe with safety device. Prefilled syringes (PFSs) are an optimal method of delivering biologics because they provide for easy administration, decrease ...

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 ...

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 ...

Astellas is set to restart trials for its age-related macular degeneration (AMD) program ASP7317 after improving production and analytical process for the embryonic stem cell-derived candidate.

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 ...

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: Typical sequence of pharmaceutical-manufacturing and equipment-cleaning operations in multiproduct equipment; the red and green bars represent batches of previously and subsequently ...