Search results for "2014" in Articles / App Notes
Article
Manufacturers Struggle with Breakthrough Drug Development
31, 2014, manufacturers submitted 140 requests for breakthrough status for drugs and biologics; the agency has approved 39 of these, approximately 30%, and denied 76. New approvals in 2013 included th…
Article
A Look Ahead at BioPharma Manufacturing and Regulation
The US Health and Human Services (HHS) Secretary must issue performance reports on these goals for fiscal years (FY) 2014 and 2016. BioPharm International spoke to FDA about these issues in a special …
Article
Real-Time Characterization of Biotherapeutics and Comparability of Biosimilars
Today 19, 1040–1044 (2014).
7. P. Safsten, Methods Mol.Biol. 524, 67–76 (2009).
8. D. G. Myszka, Methods Enzymol. 323, 325–340 (2000).
9. R. Karlsson and A. Falt, J. Immunol. Methods…
Article
N-Glycan Analysis of Biotherapeutic Proteins
32 (10), 992-1000 (2014).
4. D.M. Ecker, S.D. Jones, and H.L. Levine, mAbs 7 (1), 9-14 (2015).
5. L. Liu, J. Pharm. Sci. 104 (6), 1866-1884 (2015).
6. F. Crick, Nature 277, 561…
Article
Impact of Manufacturing-Scale Freeze-Thaw Conditions on a mAb Solution
126-133 (2014).
5. V. Rombach-Riegraf et al., PLoS ONE. 9 (1), e86322 (2014).
6. H.C. Mahler et al., J. Pharm. Sci. 98 (9), pp. 2909-2934 (2009).
7. P.A. Shamlou et al., Biotec…
Article
Advancing Single-Use Technology Through Collaboration
27 (3) (2014), www.biopharminternational.com/environmental-lifecycle-assessment-single-..., accessed August 23, 2016.
2. BioPharm International Editors, “Amgen Opens Single-Use Manufacturing Plant…
Article
Perfusion in the 21st Century
Konstantinov and CL Cooney, White Paper on Continuous Biopprocessing, Continuous Manufacturing Symposium, Journal of Pharmaceutical Sciences 104:813-820, May 20-21, 2014.
5. C. Challener, “Focus o…
Article
Design and Qualification of Single-Use Systems
EMA, EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use, Annex 15: Qualification and Validation, February 2014.
7. BPSA, Component Quality Test Matri…
Article
CMOs Continue to Improve Overall Biomanufacturing Performance
2014 (Select Responses).
Given that CMOs have long been at the forefront of single-use adoption, it’s perhaps more interesting to look at factors that are rising in importance for CMOs. …
Article
Taking a “Development-by-Design” Approach to Cell Therapies
22, 2014 webcast for the International Society for Cell Therapy (3).
Have the end in mind
Such things as formulation issues, dosage potency, impurities, residuals, and microbial assurance need…