Search results for "2014" in Articles / App Notes
Article
What’s In a Name? For Biosimilars, A Lot
Van Hook, "Role of USP Quality Standards in the Nonproprietary Naming of Biologic Drugs," webinar on Biosimilar Naming & Substitution through FDLI–Food and Drug Law Institute, March 10, 2014, www.fdli…
Article
A Bright Future for the Plasma Fractionation Industry
In March 2014, Biogen received its recombinant Factor IX-Fc fusion protein (Alprolix™) approved by FDA, and in December, CSL Behring also submitted a biologics license application (BLA) for the market…
Article
Optimization of Protein Expression in Escherichia Coli
May 01, 2015
By Siavash Bashiri, David Vikström, Nurzian Ismail
BioPharm International
Volume 28, Issue 5
Production of proteins for manufacturing therapeutics and pharmaceuticals is a c…
Article
Ensuring the Quality of Biologicals
May 02, 2015
By Stephen Wicks, PhD
Pharmaceutical Technology
Volume 39, Issue 5
The European Pharmacopoeia (Ph. Eur.), which celebrated its 50th anniversary in 2014, provides common …
Article
Modern Manufacturing Systems Key to FDA Quality Initiative
68, Risk-Based Approach for Prevention and Management of Drug Shortages (PDA, 2014).
Article Details
Pharmaceutical Technology
Vol. 39, Issue 4
Pages: 16-18
Citation: When referring t…
Article
Quality by Design and Extractable and Leachable Testing
USP 37–NF 32 (US Pharmacopeial Convention, Rockville, MD, 2014).
4. FDA, Guidance for Industry, Container Closure Systems for Packaging Human Drugs and Biologics (Rockville, MD, May 1999).
5. …
Article
Viral Clearance Challenges in Bioprocessing
Nov 1, 2014
By: Cynthia Challener, PhD
BioPharm International
Volume 11, Issue 27, pp. 42-44
Removal and inactivation of adventitious and endogenous viruses have traditionally been achieve…
Article
DoE Provides Benefits, but Preparation Is Necessary
Nov 1, 2014
By: Cynthia Challener, PhD
BioPharm International
Volume 11, Issue 27, pp. 28-29
Using a design-of-experiment (DoE) approach allows a formulation development scientist t…
Article
Using Quality by Design to Develop Robust Chromatographic Methods
Sep 2, 2014
By: Melissa Hanna-Brown, Kimber Barnett, Brent Harrington, Tim Graul, Jim Morgado, Stephen Colgan, Loren Wrisley, Roman Szucs, Gregory Sluggett, Gregory Steeno, Jackson Pellett
Pha…
Article
Challenges and Trends in Biopharma Facility Design
Sep 1, 2014
By: Susan Haigney
BioPharm International
Volume 27, Issue 9, pp. 26-30
Facility design is an important aspect of biopharmaceutical manufacturing. “Global deployment, cost…