Search results for " review" in Articles / App Notes
Article
Biopharma Seeks Balance
Applications that lack understanding of how the drug works can slow the review process.
Looking inward, FDA recently outlined plans to modernize drug review efforts at the agency to give scient…
Article
Understanding Validation and Technical Transfer, Part 3
Initially, development information can be kept in research or laboratory notebooks, but as clinical use becomes likely, formal development reports and initial validation work should be prepared, revie…
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Applying GMPs in Stages of Development
Areas to be reviewed to determine the appropriate level of control needed in concert with the phase development stage include: level of validation of test methods, level of detail needed in batch reco…
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Modeling and Miniaturization: Key Topics at Successful HTPD Conference
Ottens reviewed how knowledge-based chromatographic process development based on mechanistic modeling will become more important and more utilized in the industry in the coming years. He also emphasiz…
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Impact of Media Components on CQAs of Monoclonal Antibodies
In this 37th article in the “Elements of Biopharmaceutical Production” series, the authors review the topic of how media components modulate the quality of recombinant protein products and explore a r…
Article
Being Thorough When Transferring Technology
…portantly for biopharmaceuticals, are they capable and competent? The latter can best be assessed by reviewing the credentials of those involved and their prior experience and success with tech trans…
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Biosimilars to Drive Modern Manufacturing Approaches
The agreement expands communication between FDA reviewers and manufacturers to provide more advice on biosimilar protocols and development programs to reduce multiple review cycles on new applications…
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Efforts Accelerate to Streamline Postapproval Change Process
Varying regulatory and data requirements in each nation means that approximately 140 regulatory bodies review the same core data and information over and over again, following 140 separate timelines, …
Article
GMP Challenges for Advanced Therapy Medicinal Products
Cell Therapy Catapult UK, EC Review of the ATMP Regulation—Cell Therapy Catapult Responses (London, 2014).
7. European Commission, Report to European Parliament and the Council: Regulation (EC) No.…
Article
Implications of Cell Culture Conditions on Protein Glycosylation
Richard Easton
This article reviews the implications of cell-culture conditions on biologic product quality, focusing on glycosylation and analytical techniques for its accurate assessment. Glyco…