Cell-line development enhances biopharmaceutical production capacity and quality, but complex biologics like bsAbs and ADCs present new challenges.

Biotechnology company Leucid Bio announced a strategic collaboration with Syenex, an open-source gene therapy platform firm. Leucid will gain access to Syenex’s VivoCell Platform for in vivo delivery ...

The company is struggling to make ends meet as it loses a major undisclosed client.

Authors explore complexities in scaling gene-therapy production with special attention is to monitoring and enhancing ...

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) ...

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 ...

Components of a cell-free protein synthesis reaction (extract, supplements, and a DNA template) with the key reactions that occur when they are combined A growing area in which CFS platforms are ...

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 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 ...

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 ...

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 ...

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 ...