Search results for " sourcing"
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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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Cytiva and 4Tune Engineering Collaborate on Cell Therapy Quality Risk Management
The collaboration addresses the need for risk mitigation plans in cell therapies.
On Dec. 3, 2020, Cytiva and 4Tune Engineering, a manufacturing-sciences and technology company, announced that th…
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Akron Bio Will Install a Cytiva FlexFactory to Manufacture Plasmid DNA
Cytiva will provide the first FlexFactory to be used in the manufacture of pDNA to Akron Bio.
Cytiva will provide its FlexFactory, a flexible, single-use platform, to enable Akron Biotech to m…
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Innovations in Cell Culture: Manufacturing the Future
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“Innovations in Cell Culture” is a new virtual series from Cytiva, where we will explore and discuss the needs of the biopharma industry with a panel of industry …
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ISPE Releases Cleaning Validation Guide
ISPE has released new guidance on the cleaning validation lifecycle, written by a group of experts and reviewed by regulators and practitioners.
The International Society for Pharmaceutical Engin…
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Cytiva Invests $500 Million Over 5 Years to Expand Global Capacity
The investment will include new manufacturing lines and increased automation to deliver additional manufacturing capacity.
On Sept. 13, 2020, Cytiva, announced that it is investing $500 million o…
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Cytiva Introduces the Xcellerex Automated Perfusion System
The APS system comes equipped with filter switching, liquid management, and cell bleed to reduce risk of human error and increase process robustness.
Cytiva announced on Sept. 16, 2020 that it i…
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EMA Confirms Standards for COVID-19 Treatment Evaluations
The agency sent an open letter to European Ombudsman Emily O’Reilly affirming the agency’s intention to apply the same standards to the evaluation of COVID-19 treatments as it does to other medicine…
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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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Ajinomoto Bio-Pharma Services, CytoDyn in Manufacturing Partnership for COVID-19 Drug
On May 5, 2020, Ajinomoto Bio-Pharma Services (Aji Bio-Pharma), a contract development and manufacturing organization, announced that it has entered into a manufacturing services agreement with Cyto…