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) ...

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 ...

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 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: Hierarchical model schematic; information from all base-level models is communicated to a top-level model through their respective matrices (T j) into a consensus matrix R. R is used to ...

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 ...

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 ...

Clarification of bulk cell-culture broth is the first step in biologics purification. Solid particles such as cells and cellular debris are removed, and the resulting material is processed through 0.2 ...