Search results for "2014"
Article
Preclinical Evaluation of Product Related Impurities and Variants
Preclinical Evaluation of Product Related Impurities and Variants
The approaches for sample preparation of preclinical evaluation of safety and efficacy are addressed taking into consideration the s…
Article
Lessons Learned Accelerate Vaccine Development
The successes achieved by leading manufacturers in response to the Ebola outbreak in 2014 suggest that actions can be taken to speed up vaccine development.
Early bioprocessing challenges
The …
Article
Continuous Processing for the Production of Biopharmaceuticals
5 2014).
7. D. Voisard et al., Biotechnol. Bioeng. 82 (7), pp. 751–765 (2003).
8. W.G. Whitford and B.L. Pence, BMC Proceedings 7 (suppl 6), pp. P39 (2013).
9. L.D. Garza-García et al., La…
Article
Antibody Production in Microbial Hosts
992–1000 (2014).
2. J.G. Elvin, R.G. Couston, and C.F. van der Walle, Int. J. Pharm. 440 (1), pp. 83–98 (2013).
3. L. Liu, J. Pharm. Sci. 104, pp. 1866–1884 (2015).
…
Article
Tools for Continuous Bioprocessing Development
117–137 (2014).
16. V. Janakiraman et al., Biotechnol. Prog. doi: 10.1002/btpr.2162 (2015).
17. M. Tai et al., Biotechol. Prog. (5), pp. 1388–1395 (2015).
18. A.W. Nienow et al., Biochem. Eng…
Article
Vaccine Development and Production Challenges Manufacturers
More troubling is the highly emotional anti-vaccine movement, which has been linked to a serious outbreak of measles that began at California’s Disneyland in December 2014 and had sickened more than 1…
Article
Ligand-Binding Assays and the Determination of Biosimilarity
FDA, in its May 2014 draft guidance on how to show biosimilarity using clinical pharmacological data, indicated that LBAs, concentration and activity assays, and PD assays were important for biosimila…
Article
Healthcare Reform in China
Sep 1, 2014
By: Jane Wan
BioPharm International
Volume 27, Issue 9, pp. 8-12
On March 25, 2014, the Chinese government announced a string of initiatives in a continued move to overhau…
Article
Quality by Design—Bridging the Gap between Concept and Implementation
…t quality-by-design workshop of EMA and Parenteral Drug Association (PDA) in London in late January 2014. According to France, the next step involves a streamlined system of regulatory review of QbD …
Article
Biopharma Outsourcing Activities Update
Most commonly outsourced activities
Results from BioPlan’s 2014 study’s preliminary data indicate that—as with the past two years—the most commonly outsourced activity is analytical testing of b…