Search results for " continuous" in Articles / App Notes
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
Defining Risk Assessment of Aseptic Processes
This is accomplished through proper building, equipment materials, and design; established and validated cleaning procedures; proper training for personnel; and continuous monitoring of the personnel …
Article
Efforts Accelerate to Streamline Postapproval Change Process
FDA is looking for ICH Q12 to outline how a sponsor should manage ECs and plan for major changes during the product lifecycle to support continuous improvement, said Mahesh Ramanadham, acting director…
Article
Lessons Learned Accelerate Vaccine Development
Collaboration and single-use technologies aided the rapid scale-up of Ebola vaccine manufacturing.
By Cynthia A. Challener
Vaccine development is a complicated process that can take many yea…
Article
A Risk-Based Genetic Characterization Strategy for Recombinant CHO Cell Lines Used for Clinical and Commercial Applications
The authors describe the ways in which manufacturers can mitigate the risks related to the integrity of recombinant transgenes expressed in CHO cells.
By Luhong He, Christopher Frye
Abstract
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Article
Going Small to Achieve Success on the Commercial Scale
Qualified scaled-down models are instrumental for conducting such characterization work, as well as for viral clearance studies, continuous process improvement, and for conducting impromptu investigat…
Article
A Bright Future for the Plasma Fractionation Industry
One of the major trends in biopharmaceutical manufacturing overall is continuous processing. This was introduced by James Higgie at CSL Behring as a future option. An alternative precipitation approac…
Article
Tackling Analytical Method Development for ADCs
Feb 01, 2015
By Cynthia Challener, PhD
BioPharm International
Volume 28, Issue 2
The targeted therapy possible with antibody-drug conjugates (ADCs) makes them an attractive class of …
Article
Finding Opportunities in Brazil
Feb 06, 2015
By Hellen Berger
BioPharm International
Volume 28, Issue 2
Brazil’s turbulent presidential election in October 2014 shed some light on the country’s political landscape …
Article
New Era for Generic Drugs
Manufacturers face regulatory overhaul, while brand-generic debates escalate over biosimilars and labeling changes.
Nov 1, 2014
By: Jill Wechsler
BioPharm International
Volume 11, Issue …