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 ...
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 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 ...
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 ...
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 ...
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 ...
For comments about how contract development and manufacturing organizations (CDMOs) manage their cell-banking quality assurance (QA) practices. I contacted long-time member of BPI’s Editorial Advisory ...
Minute virus of mice (MVM) was the model virus used for this study. (HTTPS://COMMONS.WIKIMEDIA.ORG). During virus filtration, fouling typically is caused by the presence of protein aggregates, ...
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 ...
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