Search results for " market" in Articles / App Notes
Article
FDA and EMA Extend QbD Parallel-Assessment Pilot Program
The program is open to applications for initial marketing authorizations, type-II variations, and scientific advice. Participation in the pilot is voluntary, and applicants should contact both FDA and…
Article
State of Quality and Compliance in the Biopharmaceutical Industry
…e—and the first line of defense to assure the uninterrupted supply of high-quality products to the market. Manufacturing can't be successful on its own. The quality unit is needed to help assure the …
Article
Operational Excellence: More Than Just Process Improvement
A program focused on new product introductions reduced time to market by 40%. For another manufacturer, a site-wide program generated $20 million in savings the first year and a 50% reduction in throu…
Article
Welcome to the new Process Development Forum
August 15, 2013
Welcome to the new Bioprocess Development Forum (PDF) website.
We launched www.ProcessDevelopmentForum.com two years ago as a new channel for information relevant to research…
Article
QbD and PAT in Upstream and Downstream Processing
…l pharma companies in order to ensure a fast-track initiative from R&D to license to operate and market). The risk assessment includes a review and assessment of the products CQAs when manufactured o…
Article
Addressing the Challenges in Downstream Processing Today and Tomorrow
Newer classes of biotherapies will require innovations in processing technology.
By Glen R. Bolton, Bernard N. Violand, Richard S. Wright, Shujun Sun, Khurram M. Sunasara, Kathleen Watson, Johna…