Search results for " guidelines"
Article
Challenges for biosimilar developers: A conversation with Dr. Howard Levine about new FDA draft guidelines
Howard Levine, President and Principal Consultant of BioProcess Technology Consultants, about what these guidelines mean for developers of biosimilars. Dr. Levine is based in Woburn, Massachusetts, in…
Article
USP Publishes Monoclonal Antibody Guidelines
Mar 02, 2015
By Dale Schmidt, M.S., Anita Y. Szajek, PhD, Fouad Atouf, PhD, Tina S. Morris, PhD
BioPharm International
Volume 3, Issue 28
As FDA gears up towards approving biosimilar dru…
Article
Webinar On-Demand: Novel Analytics to Improve Bioprocessing and Validation Guideline
At the recent Biotherapeutics Analytical Summit, Fredrik Sundberg presented the importance of implementation of a robust analytical control strategy to ensure drug product efficacy and patient safet…
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Advancing QbD in the EU
These guidelines cover pharmaceutical development concepts in Q8, quality risk management (QRM) in Q9, and a pharmaceutical quality system to be implemented in the different stages of a product lifecy…
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Regulation of Biosimilars: A Matter of Variability, Similarity, and Comparability
The meeting, held in October 2013, was called to consider issues raised by three of EMA’s revised guidelines on biosimilars, one covering general principles, the second on non-clinical and clinical ma…
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Ensuring Viral Safety of Viral Vaccines and Vectors
Regulatory guidelines exist for the selection, qualification, and testing of these raw materials and indicate that not only known, but also emerging viruses should be sought (12–16). There are also sp…
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Labeling of Biosimilars
In December 2014, guidelines on quality standards for biosimilars with proteins as an active substance came into effect (1), while guidance on clinical and non-clinical issues with the products was be…
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The Bullish Outlook for Biosimilars
The EU established the first legal regulatory guidelines for biosimilars in 2005 and is already streamlining them. An approved revision aims to avoid unnecessary repetition of clinical trials, by allo…
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Defining Critical Quality Attributes for Monoclonal Antibody Therapeutic Products
An approach for establishing the CQAs of a mAb product by evaluating impact and uncertainty during risk assessment.
A critical quality attribute (CQA) has been defined as “a physical, chemical, …
Article
Quality by Design—Bridging the Gap between Concept and Implementation
Nonetheless, the pharmaceutical industry has been internally adopting the QbD concepts laid down in the guidelines of the International Conference on Harmonization (ICH) covering pharmaceutical develo…