Search results for " regulators" in Articles / App Notes
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Securing the Single-Use Supply Chain
“The role of the supplier is therefore now more critical, and regulators expect drug manufacturers to mitigate any risk with close partnerships and thorough knowledge of their suppliers’ quality syste…
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Challenges in Analytical Method Development and Validation
The change to faster, more sensitive, accurate, and/or reliable test methods is encouraged by the regulators. Besides providing sufficient qualification or validation results for the new method, metho…
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The Lifecycle Change of Process Validation and Analytical Testing
It may take time for companies and regulators to fully embrace it, but I am certain its use will result in more effective process control and improved processes.
REFERENCE
1. FDA, Gui…
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Moving Biosimilars Forward in a Hesitant Market
… A better model would be one where any biosimilar that’s approved, that goes through the rigorous approval process, by regulators in the US or elsewhere is automatically deemed to be interchangeable …
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Assessing Manufacturing Process Robustness
The data-driven estimations allow for in-depth product/process understanding, proving product robustness, and are in line with regulators’ expectations that science and data be used for product and pr…
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Strategizing for Rapid Changeovers in Biologics Manufacturing
Any accelerated strategy that involves pushing the boundaries of the usual regulations should be identified up front and discussed with the regulators as early as possible (e.g., use of stable clone c…
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Moving PAT from Concept to Reality
The learning curve for process analytical technology has slowed widespread adoption.
By Cynthia A. Challener
alexlmx a- Stock.Adobe.com
Process analytical technology (P…
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Ensuring Viral Safety of Viral Vaccines and Vectors
These data should aid regulators and manufacturers in decision-making and serve as a baseline for comparison of new methods. Cell lines must also be tested for species-specific viruses, as appropriate…
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Biopharma Says It Has an Evolution in New Technologies and Processes
This week, the Process Development Forum interviews Rita Peters, editorial director of BioPharm International, about Interphex 2018.
At the 2018 Interphex trade show in New York City in April…
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Manufacturing Standards Key to Advancing Cellular and Gene Therapies
By Jill Wechsler
Amid mounting excitement over remarkable efficacy rates for new genetically modified cellular therapies, regulators and manufacturers alike face continuing challeng…