Search results for " review" in Articles / App Notes
Article
The Development and Application of a Monoclonal Antibody Purification Platform
Biotech and Gen Eng Reviews, 18 (2001), 301–327.
2. Shukla AA, Hubbard B, Tressel T, Guhan S, Low D. J Chrom B. 2007;848:28–39.
3. Low D, O'Leary R, Pujar NS. J Chrom B. 2007;848:48–63.
4.…
Article
Milestones and Moderate Progress in 2012 Drug Approvals
As Adcetris and Eylea were included in last year's review (1), they are not considered further herein.
A GENE THERAPY-BASED PRODUCT APPROVED AT LAST
The…
Article
Advancing QbD in the EU
Assessments of applications are being done in parallel by the two agencies after which the review teams will discuss lessons to be learned and identify knowledge gaps. The pilot scheme should increase…
Article
Challenges for biosimilar developers: A conversation with Dr. Howard Levine about new FDA draft guidelines
On February 9, 2012, almost two years after the Biologics Price Competition and Innovation Act was passed, FDA released draft guidelines concerning the regulatory path for biosimilars. Amy Ritter, S…
Article
Addressing the Challenges in Downstream Processing Today and Tomorrow
The purpose of the pilot program is "to gain more information on and facilitate agency review of QbD, risk-based approaches for manufacturing biotechnology products". These approaches link "attributes…