Search results for " healthcare system"
Article
State of Quality and Compliance in the Biopharmaceutical Industry
Have FDA initiatives improved manufacturing quality?
The late 1990s and early 2000s witnessed a slew of enforcement actions by FDA that included multiple Form 483 observations, warning le…
Article
Bracing for a Future Wave of Advanced Therapies
“The good news is healthcare systems have worked through this before. They’re adapting right now, I would argue, led by the commercial payers, and we will work through these challenges yet again,” Hun…
Article
Downstream Processing for Cell-Based Therapies
The increased demand for hospital and social care, coupled with complex medical interventions, has led to spiralling costs for healthcare systems globally. Advanced therapies, including cell- and gene…
Article
Improving PAT for Biologics
The complexity of biopharma processes requires innovative solutions.
Dec 01, 2014
By Cynthia Challener, PhD
BioPharm International
A key component of the quality-by-design (QbD) ap…
Article
Platform Technologies Improve Protein Expression
Platform technologies facilitate development and accelerate commercialization of protein therapeutics.
By Cynthia A. Challener
Speed to market is essential in the biopharmaceutica…
Article
Biopharma Advances Demand Specialized Expertise
Jun 15, 2015
By BioPharm International Editors
BioPharm International eBooks
Volume 28, Issue 13
Contract service providers share insights on biopharma market developments and the impl…
Article
Reliability Rooms and the Move to Proactive Supply Chain Management
Reliability Rooms and the Move to Proactive Supply Chain Management
Cross-functional reliability rooms identify risk and planning metrics, provide insights for production forecasts, and predict tren…
Article
The Evolving Role of Starting Materials in Cell and Gene Therapy
The Evolving Role of Starting Materials in Cell and Gene Therapy
Accelerated approval pathways and growing demand for cell and gene therapies are putting pressure on providers of cellular starting m…
Article
From Darwin to Recombinant Fc Multimers
Uwe Schlenkrich, publisher of Hemophilia News, presented the patient perspectives on the industry and the regulations, especially how the German healthcare system affects patients’ lives. Another pres…
Article
Drug Quality Key to Innovation and Access
By Jill Wechsler
Amidst multiple challenges to the structure and governance of the US healthcare system, bio/pharmaceutical manufacturers will face a host of issues in bringing safe and effective …