Search results for "2014"
Article
Reimagining Affordable Biosimilars
List of approved biosimilars in the past five years (2014–2019) with the reported nonclinical animal models, compiled from various sources. EU is European Union.
Regulatory transformations
…
Article
Leveraging Computational Models of Glycosylation for Biopharma QA
86 (1) 576–584 (2014).
21. P.M. Jedrzejewski, et al., Int. J. Mol. Sci. 15 (3) 4492–4522 (2014).
22. N.S. Wong, et al., Biotechnol. Bioeng. 107 (2) 321–336 (2010).
23. R.K. Grainger and D.…
Article
An Analytical Approach to Biosimilar Drug Development
The single assay approach became the standard in the industry after 2014 when the uniform approach for determining bioanalytical biosimilarity recommended by Marini et al. (3) became widely adopted.
…
Article
Modeling the Degradation of mAb Therapeutics
118 (36) 10595–10606 (2014).
18. C. J. Roberts, J. Phy. Chem. B.107 (5) 1194–1207 (2003).
19. D. Kameoka, E. Masuzaki, T. Ueda, et al., Biochem.142 (3) 383–391 (2007).
20. B. A. Sal…
Article
Bioburden Control in the Biopharmaceutical Industry
Protecting against microbiological contamination over the whole manufacturing process grows increasingly important.
By Mostafa Eissa
The biopharmaceutical industry has witn…
Article
Managing Residual Impurities During Downstream Processing
In addition to these biologics-specific chapters from USP, FDA published draft guidance on elemental impurities in June 2016 (3) following the issuance in 2014 of the International Council for Harmoni…
Article
Downstream Processing for Cell-Based Therapies
85 (0), 79–88 (2014).
8. A.W. Nienow et al., Biochem. Eng. J. 108, 24–29 (2016).
9. L.Y. Sun et al., Cell Prolif. 43 (5), 445–456 (2010).
10. H.S. Yang et al., Cell Transplant.…
Article
Mechanistic Modeling of Preparative Ion-Exchange Chromatography
A 1359, 170–181 (2014).
5. E. von Lieres et al., Chemie Ingenieur Technik 86 (9), 1626–1626 (2014).
6. T. Hahn et al., J. Chem. Educ. 92 (9), 1497–1502 (2015).
7. A. Sellberg e…
Article
Biopharma in 2016: Higher Quality Drugs, Less Expensive Manufacturing
The global biopharmaceuticals market was valued at $162 billion in 2014 and pre¬dicted by Persistence Market Research to grow at a compound annual growth rate of 9.4% from 2014 to 2020 to reach $278 b…
Article
Real Time Continuous Microbiological Monitoring
Denoya, “BioLaz: Real Time Microbial Monitoring in an Environmental Monitoring Program,” Presentation at the European Compliance Academy (Prague, 2014).
3. T. S. Blacker, Nature Communicat…