Search results for " review" in Articles / App Notes
Article
Framing Biopharma Success in 2016
FDA’s expedited pathways for drug approval have proved successful; 60% of the 2015 approvals were designated in one or more of the expedited pathways (fast track, breakthrough, priority review, and ac…
Article
Biacore Concentration and Ligand-Binding Analyses
In this white
paper, the use of Biacore for active concentration measurements, target binding, and Fc receptor (FcR) analysis is reviewed along with the use of these assays for assessment of drug po…
Article
Applications of Surface Plasmon Resonance for Detection of Bispecific Antibody Activity
Spasevska, BioSciences Master Reviews. Department of Biology, University of Lyon (January 2014), accessed on Sept. 22, 2015.
23. D.W. LaFleur et al., mAbs 5 (2), pp. 208-18 (2013).
…
Article
Cleaning of Dedicated Equipment: Why Validation is Needed
The quality of an API is intrinsically related to the cleaning procedure employed; therefore, this aspect needs to be adequately addressed by the manufacturers and deeply reviewed by regulatory author…
Article
Aseptic Processing: Keeping it Safe
Jimenez, American Pharmaceutical Review 15 (1), pp. 42–57 (2012).
2. The United States Department of Justice, “14 Indicted in Connection with New England Compounding Center and Nationwide Fungal M…
Article
Using Single-Use Technologies in Downstream Processing
If there is not sufficient level of review to confirm compatibility with process streams or if all materials of construction in a given single-use system are not known upfront, this issue could easily…
Article
Biopharma Advances Demand Specialized Expertise
Integrating risk-based review, GMP inspection, implementation of quality by design, and the new FDA process validation guidance within one office is expected to significantly change the biopharmaceuti…
Article
A Bright Future for the Plasma Fractionation Industry
Several novel -- or maybe better described as technologies still under development – were reviewed and some progress can now be seen in some cases. Expanded bed adsorption (EBA) technology, precipitat…
Article
The Bullish Outlook for Biosimilars
Manufacturers of branded biologics will find value in conducting a thorough review of their patient, physician, pharmacist, and supply chain support programs to identify opportunities for implementing…
Article
Technologies and Practices Must Evolve to Meet Demand
Jenkins, CDER New Drug Review: 2014 Update, presented at FDS/CMS Summit (Dec. 11, 2014, Washington, DC).
2. BioPharm International, BioPharm International Manufacturing Trends 2015 survey.
3. …