Search results for " guidelines"
EU Sets Guidelines for Biosimilar Monoclonal Antibodies
To supplement an eight-year-old basic regulation laying down the general principles behind the introduction of biosimilars, EMA has issued a series of product-specific guidelines. These cover biosimil…
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…
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…
Novel Analytics to Improve Bioprocessing and Validation Guideline Review
The presentation also covers the latest regulatory strategies including the new surface plasmon resonance (SPR) validation guidelines.
Webinar On-Demand: Novel Analytics to Improve Bioprocessing and Validation Guideline
At the recent Biotherapeutics Analytical Summit, Fredrik Sundberg from GE Healthcare presented the importance of implementation of a robust analytical control strategy to ensure drug product efficac…
Guidelines for protein purification at low temperature
This document will provide you with general guidelines on how to successfully purify proteins under such conditions.
Guidelines for selecting normal flow filters
Proper selection of normal flow filters leads to increased process efficiency from early phase product development through to full-scale biopharmaceutical production. By Jonathan Royce, Jeffrey …
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…
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…
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…