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 ...

The biopharmaceutical industry is at the forefront of technological advancements, with “biopharma 4.0” revolutionizing the way biomanufacturing is conducted (1). The concept combines automation, ...

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) ...

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 ...

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 ...

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 ...

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 ...