Search results for " regulations"
Article
Taking a “Development-by-Design” Approach to Cell Therapies
Countries around the world, most recently Japan, have passed regulations designed to speed development of these treatments, which are now a big and growing global business.
In 2013, according to t…
Article
Global Expansion Shapes Drug Oversight
Regulators and industry organizations explain policies and standards to manufacturers and authorities in all regions.
Few FDA officials discuss pharmaceutical regulation these days without …
Article
Traceability in Western Blot Imaging: Considerations for GxP
In regulated environments, electronic record-keeping can improve both traceability and efficiency – but compliance with regulations like Code of Federal Regulations Part 11 and European Union GMP Anne…
Article
The Importance of Partnering for Bioanalytical Studies
The Importance of Partnering for Bioanalytical Studies
Yakobchuk Olena/Stock.Adobe.com
Bioanalytical studies are an important aspect of biologic drug development that may necessitate…
Article
Biopharma Seeks Balance
Biopharma Seeks Balance
Biopharma companies can balance competing demands from patients, investors, and regulators by keeping a focus on science.
By Rita C. Peters
…
Article
Impact of Media Components on CQAs of Monoclonal Antibodies
The authors review how media components modulate the quality of monoclonal antibody products.
By Anurag Rathore, Rajinder Kaur, Dipankar Borgayari
Recombinant protein products have…
Article
Design and Qualification of Single-Use Systems
Equipment Design Regulations and Guidance
While drug and vaccine manufacturers are subject to regulatory review and inspection of how equipment is used, that is not the case for the manufacturers …
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
Best Practices in Qualification of Single-Use Systems
Regulatory Requirements
For finished pharmaceuticals, FDA has issued regulations explaining cGMPs in 21 Code of Federal Regulations (CFR) 210 and 211 (5, 6). For APIs or drug substances, however, …
Article
Quality Systems Key to Lifecycle Drug Management
Jun 01, 2015
By Jill Wechsler
BioPharm International
Volume 28, Issue 6
The submission and review of manufacturing supplements is costly and time consuming for biopharmaceutical comp…