Search results for " guidelines" in Articles / App Notes
Article
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…
Article
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…
Article
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…
Article
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…
Article
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 …
Article
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…
Article
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…
Article
SEC in the Modern Downstream Purification Process
Mar 01, 2015
By R. Christopher Manzari, J. Kevin O'Donnell
BioPharm International
Volume 3, Issue 28
Since the introduction of commercial chromatography resins approximately six de…
Article
Quality by Design and Extractable and Leachable Testing
The author discusses the various ways in which a quality-by-design program can enhance the extractable and leachable assessment of a drug product.
Feb 01, 2015
By Anthony Grilli
BioPharm…
Article
Ligand-Binding Assays and the Determination of Biosimilarity
“LBAs are certainly easier for starting a development campaign, but recent regulatory guidelines indicate that a cell-based MOA bioassay should accompany the development of a drug candidate as early a…