Search results for " 2015"
Article
Reimagining Affordable Biosimilars
Advances in preclinical development play a crucial role in reducing cost for developing biosimilars.
By Anurag S. Rathore, Narendra Chirmule, and Himanshu Malani
Drug development is …
Article
Preclinical Evaluation of Product Related Impurities and Variants
A, 1406, 175-185, 2015.
24. S. Fekete, et al., Pharm. Biomed. Anal., 113, 43-55, 2015.
25. S. Fekete, et al., J. Pharm. Biomed. Anal., 102, 282-289, 2015.
26. L. A. Khawli, et al., M…
Article
Bioburden Control in the Biopharmaceutical Industry
FDA, “Warning Letters 2015,” www.fda.gov/Drugs, accessed March 24, 2017.
7. P. Cholayudth, “Application of Poisson distribution in establishing control limits for discrete quality attributes”, J…
Article
The Tide Stays High
The valuations and levels of public offering activity in 2014 and 2015 were not sustainable, and the NBI has never gotten back close to the levels it reached in 2015. Nevertheless, fundraising by emer…
Article
Antibody Production in Microbial Hosts
The authors review the status of expression of antibodies in microbial hosts and present the recent advances in the production of aglycosylated antibodies in bacteria.
By Anurag S. Rathore, Jyot…
Article
Tools for Continuous Bioprocessing Development
Could perfusion microbioreactors bring more agility to biomanufacturing?
By Rajeev J. Ram
In semiconductor manufacturing, for example, a thorough understanding of process variation allows co…
Article
Robust Optimization, Simulation, and Effective Design Space
SAS/JMP Software, Profilers and Simulation, Version 12, May 2015
4. T. Little, Robust Optimization, Design Space and Tolerance Design (Course Notes, 2015)
5. FDA, Process Validation, G…
Article
What’s In a Name? For Biosimilars, A Lot
Hernandez, "What’s In a Name? For Biosimilars, A Lot," BioPharm International 28 (6) 2015.
Article
Quality Systems Key to Lifecycle Drug Management
Pfizer is involved with some 24,000 postapproval changes a year for its 30,000 products, noted vice-president Roger Nosal at the April 2015 CMC Workshop sponsored by the Drug Information Association (…
Article
Biomanufacturing Outsourcing Globalization Continues
A solid majority of biologics developers indicated in the 2015 study that they will not offshore any of their process development for biomanufacturing over that period, a result that is consistent wit…