Search results for " meeting"

Article Pandemic Alters Policies and Practices for Drug Development and Regulation
Regulatory flexibility In addition to remote field inspections, FDA review staff organized virtual meetings with medical product sponsors to assess and devise appropriate, yet more flexible R&D …

Article Maximum Output Starts with Optimized Upstream Processing
By Cynthia A. Challener Biopharmaceutical companies and contract manufacturers respond to changing demand dynamics for upstream bioprocessing capacity. Significant growth in the develo…

Article Assessing Manufacturing Process Robustness
A structured assessment process can determine compliance to lifecycle process-validation requirements for biopharmaceuticals. By: Ajay Pazhayattil, Sanjay Sharma, Amol Galande, Marzen…

Article Setting Up Bioprocessing Systems for Digital Transformation
Digitalization of bioprocessing operations, equipment, and facilities can improve workflow and output, but maintaining data integrity is a concern. By Feliza Mirasol The advancement of digit…

Article Remote Monitoring and Big Data Advance Upstream Automation
Challener As upstream processing drives toward higher efficiencies in meeting demand, it requires optimizing the current state of manufacturing with the goal of achieving real-time release and an …

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 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 Eliminating Residual Impurities Starts with a Strategic Plan
The implementation of a risk-based strategy for the testing of residual impurities, meanwhile, offers the potential to significantly reduce the amount of testing needed while still meeting regulatory …

Article Maximizing the Effectiveness of Upstream Bioprocessing Through the Combination of Lab Informatics and Instrumentation
With a scale-out rather than scale-up approach to meeting production requirements, there is a greater risk of variability in process conditions and product quality between individual bioreactors. Bior…

Article Mapping a Route for Cell and Gene Therapy Process Development
Common validation hurdles One of the primary requirements for process validation is to demonstrate documented evidence that the scaled process can consistently produce the final product, meeting t…

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