Contract development and manufacturing organization (CDMO) Matica Biotechnology has partnered with Calidi Biotherapeutics to ...
Explore the latest news and expert commentary by Alexander Seyf, brought to you by the Contributor of BioProcess ...
This webcast features: Tania Chakrabarty, PhD, Senior Manager, Innovation Leader, Research and Development, Pharma Analytics, Thermo Fisher Scientific Plasmids are common raw materials in the ...
Explore the latest news and expert commentary by Anand Naik, brought to you by the Contributor of BioProcess International.
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 continues to grow globally as it recovers from the COVID-19 pandemic. The significant COVID-driven expansion of bioprocessing activities worldwide created supply-chain ...
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: Physical and procedural model implementation based on principle 88 of International Society for Automation (ISA) standards for batch process control Automation can improve efficiency, track ...
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 ...
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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