Search results for "regulatory"
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Detecting Protein Aggregates and Evaluating their Immunogenicity
Regulatory agencies are increasingly asking drug manufacturers to characterize particulate matter in biologics.
Unfortunately, there is little general agreement about how to handle the problem of …
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Tackling Analytical Method Development for ADCs
In such a rapidly evolving area, the regulatory requirements are clearly evolving as more knowledge makes it into health authority submissions and into the peer-reviewed literature,” he says.
On t…
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Implementation of Raw Material Control Strategies in the Manufacture of Single-Use Bioprocessing Containers
…earch engineer; Shujian Yi, PhD, is senior polymer scientist; and Jeffrey Carter, PhD, is strategic regulatory services leader, all at Cytiva. Pokon Ganguli is R&D manager at Renolit Nederland B.V., …
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Securing the Single-Use Supply Chain
…ms and components must be purchased from a supplier, according to John Briggs, director of quality, regulatory, and compliance at ASI-Life Sciences. As a result, adds Mario Philips, vice-president of…
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Improving PAT for Biologics
At the same time, regulatory agencies have continued to press for tighter controls, greater understanding, and higher consistency. “Therefore, each step of the process requires a level of PAT that is …
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High-Throughput Process Development in an Historical Environment
…ting – Design of Experiments (DoE), and he also presented a case study and lessons learned from a regulatory submission that included mechanistic modelling.
In the Tuesday morning session on Mode…
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Biopharma Manufacturers Respond to Ebola Crisis
FDA also is working with WHO’s International Coalition of Medicines Regulatory Authorities (ICMRA) to facilitate testing of experimental treatments and to provide more flexibility for meeting manufact…
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Application of Quality by Design to Viral Safety
Because every biopharmaceutical has a unique manufacturing process, the regulatory agencies have thus far avoided providing prescriptive requirements for log reduction, thereby reserving the flexibili…
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A Q&A With Dr. Anurag Rathore About the Future of QbD, Part I
This phase also included discussion between the industry and the regulatory agencies (particularly the U.S. FDA) about how to go about implementing QbD. The present phase (2012-ongoing) is more about …
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Bureaucratic Roadblocks Threaten Biopharma Growth
Furthermore, Brazil’s unprecedented review of patents by the health regulatory authority, China’s increased data requirements, and Canada’s increased utility requirements all ultimately undermine the …