Contract development and manufacturing organization (CDMO) Matica Biotechnology has partnered with Calidi Biotherapeutics to ...
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Explore the latest news and expert commentary by Anand Naik, brought to you by the Contributor of BioProcess International.
According to the founder and executive chairman of the World Economic Forum, Klaus Schwab, the fourth industrial revolution began in the 21st century and is characterized by an unprecedented ...
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 ...
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 ...
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 ...
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 ...
Increasing demand for biologics and continuing limitations with single-use bioreactors (up to 5,000 L) compel some biopharmaceutical manufacturers to transfer their production processes into ...
Process capability often serves as a metric for quantifying biomanufacturing-process performance. The term refers to the extent of variation in measurable property X of a given biological product made ...