Search results for " FDA"
Article
Designing a Biomanufacturing Facility Incorporating Single-Use Technologies
Also, if producing at commercial scale, which regulatory standard is needed? Is the product approved by FDA, the European Medicines Agency (EMA), the China FDA, Brazil’s National Health Surveillance A…
Article
Tools for Continuous Bioprocessing Development
In 2008, FDA rejected Genzyme’s application to produce Myozyme in a 2000-liter-scale facility under the same approval authorization given for its 160-liter-scale plant. The FDA ruling stated that the …
Article
Implications of Cell Culture Conditions on Protein Glycosylation
The authors present a review of the techniques commonly used for glycosylation analysis.
By Michiel E. Ultee, PhD, Dr. Richard Easton
This article reviews the implications of cell-culture co…
Article
Robust Optimization, Simulation, and Effective Design Space
Jul 01, 2015
By Thomas A. Little, PhD
BioPharm International
Volume 28, Issue 7, pg 40–44
Approaches to the generation of process models, optimization techniques, and application of …
Article
USP Stresses Pharmacopeial Standards at CPhI China
Keynote speakers included former FDA officials, USP experts, members of the Chinese Pharmacopoeia Commission, and senior pharmaceutical executives.
The seminar was designed to explain the latest q…
Article
Biosimilars Will Bring Significant Litigation and Patent Challenges
In that instance between Sandoz and Amgen, Sandoz did not disclose its manufacturing processes and FDA application to Amgen, the patent holder for Neupogen (filgrastim). A California judge ruled, howe…
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Challenges and Trends in Biopharma Facility Design
Quality control and building standards are also essential, with a view to meeting [European Medicines Agency] EMA, FDA, [Chinese Food and Drug Administration] CFDA, and other regulatory standards for …
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Quality by Design—Bridging the Gap between Concept and Implementation
One of the speakers at the meeting, Christine Moore, acting director of FDA’s Office of New Drug Quality Assessment (ONDQA), summarized the main concerns as being the classifying of criticality, level…
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Supplier-Change Management for Drug-Product Manufacturers
Pharmaceutical change management processes extend to the materials and services employed to manufacture and test drug products, necessitating the need for an effective supplier-initiated change …
Article
HT Multi-Product Liquid Chromatography for Characterization of Monoclonal Antibodies
US FDA. Guidance for industry. Validation of chromatographic methods. Rockville, MD; 1994.
12. US FDA. Guidance for industry. Bioanalytical method validation for human studies. Rockville, MD; 1998…