Search results for " biopharms"
Article
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…
Article
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…
Article
How To Execute Successful Data Migrations
Successful migrations require careful planning to meet business needs and maintain data integrity.
By Art Meisler
Data migration is the unglamorous task of a system implementation. …
Article
Reimagining Affordable Biosimilars
Advances in preclinical development play a crucial role in reducing cost for developing biosimilars.
By Anurag S. Rathore, Narendra Chirmule, and Himanshu Malani
Drug development is …
Article
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…
Article
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…
Article
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…
Article
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…
Article
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…
Article
Technology Innovations Improve Process Chromatography Performance
As technology matures, inefficiencies and process limitations in downstream process chromatography are improved.
By Feliza Mirasol
Selecting an appropriate separation technology fo…