Search results for " regulatory"
Article
Transformative Medicines Challenge FDA and Manufacturers
OCP receives hundreds of inquiries on issues related to product classification, many seeking early advice on the regulatory designation process. FDA officials emphasize the importance of achieving con…
Article
Patenting Prospects for Cell-Based Therapies
Accordingly, patent exclusivity will be important to defray high development and regulatory compliance costs. The nature of such therapies, and recent patent law trends regarding natural products and …
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Biosimilars to Drive Modern Manufacturing Approaches
By Jill Wechsler
As more biosimilars gain market approval in the United States, and manufacturers launch additional programs to develop competitive biotech therapies, regulatory authorities and in…
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An Integrated Approach to Ensure the Viral Safety of Biotherapeutics
Although a plethora of regulatory guidance documents have been enacted governing product safety from adventitious agents (1–16), complete risk elimination has not yet been achieved. Several examples o…
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Risk Assessment and Mitigation in Biopharmaceutical Manufacturing
Regulatory Requirements
BioPharm: What are the specific regulatory requirements for risk assessment and mitigation in biopharmaceutical manufacturing?
AstraZeneca: We are required to follow In…
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What’s In a Name? For Biosimilars, A Lot
…subset of the quality attributes of the articles in question and do not make a statement about their regulatory status, clinical attributes, or interchangeability, all of which are for FDA to determi…
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Continuous Manufacturing: A Changing Processing Paradigm
Although FDA meeting notes have claimed that “There are no regulatory hurdles for implementing continuous manufacturing (4),” there are some regulatory issues that persist with the process for biologi…
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Mechanistic Modeling: Does it Have a Future in Process Development?
…Development Forum about why he prefers mechanistic models, when they are appropriate to use, and how regulatory agencies currently view them.
What is the fundamental difference between mechanis…
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Viral Clearance Challenges in Bioprocessing
Viral clearance is assessed in small-scale tests, and regulatory guidance documents provide a general framework for how these tests should be performed (1). Even with guidance, however, demonstrating …
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Using Quality by Design to Develop Robust Chromatographic Methods
…ical methods (5) where they described two main objectives: improved method performance and increased regulatory flexibility. As yet, no pharmaceutical regulatory standards (analaogous to ICH Q8-Q11) …