Search results for " guideline"
Article
A Risk-Based Genetic Characterization Strategy for Recombinant CHO Cell Lines Used for Clinical and Commercial Applications
EMA/CHMP/BWP/534898/2008 Committee for Medicinal Products for Human Use (CHMP), Guideline on the requirements for quality documentation concerning biological investigational medicinal products in clin…
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Framing Biopharma Success in 2016
Corporate restructurings, regulatory initiatives, and biosimilars will shape biopharma development in 2016.
By Rita C. Peters
The US biopharmaceutical industry turned a new page in 2015 when…
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Tools for Continuous Bioprocessing Development
Decades of research have established these guidelines for process transfer from one platform to another. While not complete, they provide a set of recommendations that are grounded in an understanding…
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mAbs to Watch in 2016
Regeneron said in its 2015 investor notes that EULAR guidelines support the use of an IL-6 inhibitor as a monotherapy. Sailumab is likely to compete with such first-line therapies as Bristol-Myers Squ…
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Taking a “Development-by-Design” Approach to Cell Therapies
Regulations evolve
Cell therapy is still a new area for regulators, and, as Preti says, some guidelines are clear and others aren’t. “Development by design is needed throughout the process, but th…
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Quality Systems Key to Lifecycle Drug Management
The aim is to publish a document by June 2016 that builds on other ICH quality guidelines to strengthen quality assurance through harmonized management of post-approval CMC changes.
Agreement and …
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Modular Manufacturing Platforms for Biologics
Portafab, “Bio-Pharmaceutical Cleanroom Design Guidelines,” Portafab, www.portafab.com/bio-pharmaceutical-cleanroom-design.html, accessed March 25, 2015.
Article Details
BioPharm Internation…
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Tackling Analytical Method Development for ADCs
… outlined in the International Conference on Harmonization’s ICH Q5C (1) and ICH Q6B (2) biologics guidelines; however, the testing must cover both functional and physiochemical properties, including…
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SEC in the Modern Downstream Purification Process
As a general guideline for polishing steps, the maximum sample size that should be loaded onto the column is between 1% and 5% of the packed column volume. For buffer exchange and desalting applicatio…
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Quality by Design and Extractable and Leachable Testing
The FDA guideline states that CQAs are generally associated with drug substances, excipients, intermediates, and drug product, but the concept can also be applied to container closure systems. While i…