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

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) ...

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: Size-exclusion chromatography (SEC) profile shows three main regions: high–molecular-weight (HMW) species, the product main peak, and low–molecular-weight (LMW) species. The blue ...

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 ...

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 ...

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 ...

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 ...

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 continues to grow globally as it recovers from the COVID-19 pandemic. The significant COVID-driven expansion of bioprocessing activities worldwide created supply-chain ...

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 ...