Search results for " approval" in Articles / App Notes
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Advancing Global Collaboration for Drug Testing, Regulation, and Manufacturing
Regulatory authorities and biopharma companies are engaged in a range of collaborations to harmonize research methods, approval standards, and quality production methods key to expandi…
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Bispecific Antibodies are Moving from Research to Clinical Development
With recent approvals of bispecific antibodies, these complex molecules are fast moving out of the research box and into clinical pipelines.
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Enhancing Resins Addresses Purification Concerns
Christoph Burgstedt/Stock.Adobe.com
Enhancement of resin technology can improve the ability of chromatography to purify the growing landscape of increasingly complex biomolecu…
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Track-and-Trace Progress Benefits Supply-Chain Security Efforts
By Agnes Shanley
The industry has made great strides in implementing serialization technologies, while technology developers are enabling more open access to real-time transportation data.
S…
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EMA Guidance on Changes to COVID-19 Vaccines to Fight Variants
The agency is developing guidance to help manufacturers make changes to existing COVID-19 vaccines to treat new variants in the coronavirus.
The European Medicines Agency (EMA) has requested t…
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Strategizing for Rapid Changeovers in Biologics Manufacturing
Olivier Le Moal/Stock.Adobe.com
By Cynthia A. Challener
Facility and equipment design are important, but the team and its experience matter most.
Through its Operation Warp Speed pro…
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Mechanistic Modeling: Current Advantages and Future Opportunities in Biopharmaceutical Process Development
Once the first molecules, whose development process was mainly driven by modeling, have passed regulatory approval, I expect a strong demand for the type of modelling that we are doing. Based on our e…
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Production of Recombinant Adeno-associated Virus Vectors Using Microcarrier Culture of HEK293T Cells
As the gene therapy projects enter clinical Phase III or get market approval, large-scale production of viruses has become a limiting factor in the industrialization of gene therapy.
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Can Vaccine Development Be Safely Accelerated?
The overall development and approval timeline is thereby significantly reduced.
Inovio began animal testing of INO-4800, its COVID-19 vaccine candidate, in February 2020 and is aiming to begin …
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2019’s Top Bioprocessing Trends and What to Expect in 2020
FDA approvals announced during the year for cell and gene therapies prompted the need to consider manufacturing facility designs specific to cell and gene therapy workflows, as well as the need to exp…