Search results for "regulatory" in Articles / App Notes
Article
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 …
Article
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 …
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Biopharma Takes a Nervous Glance Over Its Shoulder
Strong, science-based regulatory system.
FDA has long been viewed as the gold standard for a science-based regulatory system. However, the report says, the number and complexity of regulatory…
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Novel Vaccine Technologies Meet the Need for Pandemic and Therapeutic Solutions
Smith also notes that the adoption of single-use manufacturing technology accelerates process validation and analytical testing for Novavax’s vaccines and may allow for ultimate regulatory approval of…
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Predicting Progress in Protein Aggregation
As a result, there is increasingly regulatory pressure for biopharmaceutical manufacturers to reduce the risk of immunogenicity by not only controlling, but also preventing, aggregate formation.
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