Contract development and manufacturing organization (CDMO) Rentschler Biopharma has announced a partnership with ...

But cell and gene therapies (CGTs) are catching up. During Cell and Gene Therapy International Europe 2025, held in Berlin, ...

Stéphane Bancel, CEO of vaccine maker Moderna, addressed shareholders in a letter that dissected the events of 2025 while projecting a positive outlook for the company’s future in 2026 and beyond.

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

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 ...

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 ...

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 ...

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 ...

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 ...

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