Search results for "2014" in Articles / App Notes
Article
Challenges of Protein Aggregation During Purification
Sep 1, 2014
By: Cynthia Challener, PhD
BioPharm International
Volume 27, Issue 9, pp. 32-35
Removal of protein aggregates from biologic APIs is crucial due to their potential to incre…
Article
Single-Domain Antibodies for Brain Targeting
Single-domain antibodies are emerging as credible alternatives due to their target specificity, high affinity, and cost-effective recombinant production.
Smaller recombinant antibody fragments a…
Article
EMA Invites Comments on New Guidance for Vaccine Development
The guidance on enhanced safety surveillance for seasonal influenza vaccines, which was adopted as a stand-alone document in April 2014, will be annexed to this module following its finalization.
…
Article
Defining Critical Quality Attributes for Monoclonal Antibody Therapeutic Products
October 2009, accessed June 5, 2014.
10. S. Kozlowski, “Implementation Activities for QbD: FDA Office of Biotechnology Products,” presentation at 2010 WCBP CMC Strategy Forum (Bethesda, MD, 2010).…
Article
Challenges in Analytical Method Development and Validation
Experts give insight on method transfer, QbD, and regulations for analytical method development and validation for biopharmaceuticals.
The manufacture of biopharmaceuticals presents …
Article
Bureaucratic Roadblocks Threaten Biopharma Growth
The 2014 BIO International Convention, taking place June 23-26 in San Diego, will host an Emerging Opportunities in Global Markets Forum specifically designed to highlight biotech initiatives in globa…
Article
Gowning Practices Provide Clues to cGMP Compliance
28, 2014.
Eric Bohn
About the Author
Eric Bohn is partner at Jacobs Wyper Architects, 1232 Chancellor St., Philadelphia, PA 19107, tel: 215.985.0400, www.jacobswyper.com.
Article
Novel Vaccine Technologies Meet the Need for Pandemic and Therapeutic Solutions
…electing a contract manufacturer for the production of Phase III and commercial quantities later in 2014. Inovio is also participating in a National Institutes of Health malaria vaccine initiative fo…
Article
Q&A with Industry Leader Konstantin Konstantinov, Genzyme Vice-President
Can you talk to us about the state of continuous processing in biotechnology?
A: Yes, the event is the International Symposium on Continuous Manufacturing of Pharmaceuticals (May 20-21, 2014…
Article
Trends in BioPharma Approvals in 2013
In 2013, 20 products containing new biopharmaceutical molecular entities (defined herein as recombinant proteins, monoclonal antibody or biosynthesized nucleic acid-based products) were approved in t…