Search results for " regulatory" in Articles / App Notes
Article
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…
Article
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…
Article
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…
Article
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…
Article
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…
Article
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…
Article
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 …
Article
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) …
Article
EMA Collaborates with HTA Assessment Networks
First a drug has to be approved for its quality, safety, and efficacy by one or more regulatory authorities. This approval can be either by the central London-based European Medicines Agency (EMA) for…
Article
FDA Seeks Metrics to Define Drug Quality
Predictive or forecast metrics include maintenance backlogs, complaint trends, internal audits, and the findings of regulatory inspections. Yield analysis or abnormalities of product per batch over ti…