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) ...

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 ...

Pandemics such as the current COVID-19 outbreak pose tremendous healthcare and economic challenges. Vaccines hold promise for controlling pandemics; however, substantial challenges come with ...

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 ...

Japan’s regulators have approved ARCT-154, CSL and Arcturus’ COVID-19 vaccine based on self-amplified messenger RNA (sa-mRNA) technology. Japan’s Ministry of Health, Labor and Welfare (MHLW) gave the ...

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 ...

Figure 1: Monoclonal antibodies (MAbs) exert their biological effects through both Fab‑and Fc-mediated activities. The complexities of biomanufacturing combined with heterogeneity introduced by ...

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 ...

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 ...