Search results for " 2015"
Article
Labeling of Biosimilars
Feb 01, 2015
By Sean Milmo
BioPharm International
The European Medicines Agency (EMA) has reached a key stage in the lengthy process of creating a regulatory framework for the development and…
Article
Driving Improved Access to Biosimilars
In a formal statement in December 2018 (2), former FDA commissioner Scott Gottlieb referred to insulin prices, which have increased nearly 600% between 2001 and 2015, with the average US list price ri…
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
Downstream Processing for Cell-Based Therapies
17, 2015).
17. F. Masri, Cell Gene Ther. Insights 2 (4), 463–471 (2016).
18. N. Hutchinson et al., Biotechnol. Bioeng. 95 (3), 483–491 (2006).
19. N.B. Jackson, J.M. Liddell, a…
Article
Mechanistic Modeling of Preparative Ion-Exchange Chromatography
21, 2015).
4. N. Borg et al., J. Chromatogr. 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. Edu…
Article
Efforts Accelerate to Streamline Postapproval Change Process
To spur the Q12 process, FDA in 2015 issued a draft guidance on defining and reporting ECs (2). The guidance describes which elements of a control strategy could be considered ECs necessary to assure …
Article
Perfusion in the 21st Century
Woodcock, “Introducing New Technology in Pharmaceutical Manufacturing,” presented in Integrated Continuous Manufacturing II, San Francisco, CA, 2015.
9. J. Pollock, et al., Biotechnology and Bioen…
Article
An Integrated Approach to Ensure the Viral Safety of Biotherapeutics
1, 2015), pp. 719.
8. European Pharmacopoeia, Monograph: Bovine Serum, 01/2008:2262, pp. 1506–1507.
9. ICH, Q5A (R1) Quality of Biotechnological Products: Viral Safety …
Article
GMP Challenges for Advanced Therapy Medicinal Products
…ene- and cell-therapy products and tissue-engineered treatments, was due to be completed in November 2015. The guidelines, which will be drawn up by the European Commission, however, are taking a lon…
Article
Implications of Cell Culture Conditions on Protein Glycosylation
The authors present a review of the techniques commonly used for glycosylation analysis.
By Michiel E. Ultee, PhD, Dr. Richard Easton
This article reviews the implications of cell-culture co…