Search results for " 2016"
Article
Process Development: What May Lie Ahead in 2018?
While only 22 new drugs were approved in 2016, FDA gave its thumbs up to 46 new drugs in 2017 (of which approximately one-quarter were biologics). The figures for all new drug approvals are in line wi…
Article
Manufacturing Standards Key to Advancing Cellular and Gene Therapies
A Forum on Regenerative Medicine established in 2016 by the National Academies for Science, Engineering, and Medicine (NASEM) is addressing these issues as part of its broader examination of the state…
Article
Patenting Prospects for Cell-Based Therapies
19, 2016).
5. Leahy-Smith America Invents Act, Public Law 112-29, § 33, 125 Stat. 284 (Sept. 16, 2011).
6. Diamond v. Chakrabarty, 447 U.S. 303 (1980).
7. Funk Bros.Seed Co. v. Kalo Inocul…
Article
Impact of Media Components on CQAs of Monoclonal Antibodies
The authors review how media components modulate the quality of monoclonal antibody products.
By Anurag Rathore, Rajinder Kaur, Dipankar Borgayari
Recombinant protein products have…
Article
Avoiding Investigational Failures and Discrepancies
25, 2016. Accessed June 19, 2017.
2. FDA, Guidance for Industry, Quality Systems Approach to Pharmaceutical CGMP Regulations (CDER, September 2006).
Article
Single-use Bioreactors Have Reached the Big Time
The decision to use disposable bioreactors is now driven by commercial rather than technological considerations.
By Cynthia A. Challener
Single-use bioreactors available from various vendors…
Article
Downstream Processing Continues to Worry CMOs
CMOs are working hard to improve performance by investigating new technologies for filtration and purification.
By Eric S. Langer
Downstream processing continues to be a significant pain poi…
Article
A Q&A With Günter Jagschies: Recovery of Biological Products Conference Series
The theme for Recovery 2016 is ‘Smart BioProcessing.’ Can you elaborate on this theme?
While focusing on downstream processing, RXVII will pay a lot of attention to the fact that no part of a biop…
Article
A Look Ahead at BioPharma Manufacturing and Regulation
The US Health and Human Services (HHS) Secretary must issue performance reports on these goals for fiscal years (FY) 2014 and 2016. BioPharm International spoke to FDA about these issues in a special …
Article
Analytical Considerations for Successful Upstream Process Development with Spivey and Lane
In 2016, he moved to the drug product science and technology department at BMS.
Today we're talking with him about upstream processes, continuous manufacturing, and just in general how the indus…