Search results for " 2015"
Article
Leveraging Computational Models of Glycosylation for Biopharma QA
Close collaboration between academic and industrial groups is vital to ensuring glycosylation models are fit for deployment.
By Ioscani Jiménez del Val
Good Studio/S…
Article
N-Glycan Analysis of Biotherapeutic Proteins
This article summarizes the approaches, challenges, and future perspectives for the characterization of N-glycans in biopharmaceutical products.
By Aled Jones
Protein glycosylation, the addi…
Article
CMOs Continue to Improve Overall Biomanufacturing Performance
Figure 1: Improving biomanufacturing performance for CMOs, 2015 v. 2014 (Select Responses).
Given that CMOs have long been at the forefront of single-use adoption, it’s perhaps more inte…
Article
Drug Discovery and Development in India
Japan’s move to set up the Japan Agency for Medical Research and Development (AMED) in April 2015 also represents another initiative to boost drug discovery.
Future outlook
BMI remains optimis…
Article
Breakthrough Drugs Raise Development and Production Challenges
Jul 01, 2015
By Jill Wechsler
BioPharm International
Volume 28, Issue 7, pg 8–9
The FDA program to expedite the development and approval of innovative drugs for serious and life-threat…
Article
Modern Manufacturing Systems Key to FDA Quality Initiative
She reiterated this approach at the February 2015 annual meeting of the Generic Pharmaceutical Association, urging development of continuous manufacturing operations that can achieve consistent produc…
Article
Vaccine Development Faces Urgency and Challenges
By Jill Wechsler
The Ebola outbreak in 2015 and the current stampede to develop a new vaccine to combat the Zika virus illustrate the increasingly important role of vaccines in advancing public he…
Article
Continuous Processing for the Production of Biopharmaceuticals
1196–205 (August 2015).
17. J.R. Alford et al., J. Pharm. Sci. 97 (8), pp. 3005–3021 (2008).
18. A. Jungbauer, Trends Biotechnol. 31 (8), pp. 479–492 (2013).
19. R. Schlegl et al., Chem. E…
Article
Virus-like Particles as Therapeutic Moieties of the Future
Analytical and functional characterization of virus-like particles enables process reproducibility and product consistency.
By Ramesh Kumar, Manidipa Banerjee, Anurag S. Rathore
Virus-like…
Article
FDA Approves First Biosimilar
The approval trails a unanimous positive vote in January 2015 from FDA’s Oncologic Drugs Advisory Committee. To date, there are a total of five 351(k) applications that are publicly disclosed, includi…