Search results for " patients" in Articles / App Notes
Article
Breakthrough Drugs Raise Development and Production Challenges
Manufacturers and FDA look for innovative strategies to meet accelerated timeframes.
Jul 01, 2015
By Jill Wechsler
BioPharm International
Volume 28, Issue 7, pg 8–9
The FDA pro…
Article
Using Single-Use Technologies in Downstream Processing
The use of single-use systems in downstream processing offers benefits in filtration and sampling and may reduce the risk of contamination.
Jul 01, 2015
By Susan Haigney
BioPharm Inter…
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
USP Publishes Monoclonal Antibody Guidelines
Mar 02, 2015
By Dale Schmidt, M.S., Anita Y. Szajek, PhD, Fouad Atouf, PhD, Tina S. Morris, PhD
BioPharm International
Volume 3, Issue 28
As FDA gears up towards approving biosimilar dru…
Article
Detecting Protein Aggregates and Evaluating their Immunogenicity
Mar 01, 2015
By Randi Hernandez
BioPharm International
Volume 3, Issue 28
Aggregation in biopharmaceuticals remains a major concern and threatens the stability of a product. Protein …
Article
Finding Opportunities in Brazil
Even when physicians prescribed branded drugs, some patients would switch their medications to less expensive generic options.
As a result, global pharma companies, according to the report, had co…
Article
What Drove Biopharma Development in 2014?
…a flows across the entire life cycle of the drug, and improve overall efficacy and cost-efficacy for patients and manufacturers. So, it is no surprise that half of the top 10 stories read by PDF visi…
Article
Biopharma Manufacturers Respond to Ebola Crisis
The agency also permitted Tekmira Pharmaceuticals (Vancouver) to treat infected patients with its experimental RNA interference drug by converting a “full clinical hold” to a “partial hold” on a Phase…
Article
Application of Quality by Design to Viral Safety
A quality-by-design approach defines a range of potential viral contaminants of source materials and can be used to effectively achieve viral clearance.
Oct 1, 2014
BioPharm International
…
Article
Challenges and Trends in Biopharma Facility Design
Experts discuss the future of modular manufacturing and the challenges that biopharma manufacturers face in facility design.
Sep 1, 2014
By: Susan Haigney
BioPharm International
Volu…