Search results for " Advanced therapeutic medical produ…"
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
Vaccine Development Faces Urgency and Challenges
Global outbreaks energize vaccine R&D and drive production modernization.
By Jill Wechsler
The Ebola outbreak in 2015 and the current stampede to develop a new vaccine to combat the Zika vir…
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Top Process Development Trends for 2021 and a Look into 2022
The COVID-19 pandemic continues to shape bioprocess development trends, and many lessons have been learned from industry’s response to and preparedness for dealing with a public health crisis. Howev…
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Patenting Prospects for Cell-Based Therapies
Cell-based therapies are moving medical treatments forward, but intellectual property uncertainties may delay progress.
By Kevin Noonan
Treatment using cell-based therapies is a rapidl…
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Drug Quality Key to Innovation and Access
FDA plans to advance initiatives for ensuring reliable production of drugs and biologics in 2017.
By Jill Wechsler
Amidst multiple challenges to the structure and governance of the US health…
Article
Driving Improved Access to Biosimilars
Driving Improved Access to Biosimilars
New guidance from FDA, including standards for interchangeability, is expected to speed development of biosimilars, but experts warn against oversimplifying ri…
Article
mAbs to Watch in 2016
By Randi Hernandez
Of the 45 new molecular entities and new therapeutic biological products approved by FDA in 2015, nine products were monoclonal antibodies (mAbs). And there may be many more o…
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Biopharma Manufacturers Respond to Ebola Crisis
Demand for new therapies and vaccines spotlights production challenges.
Oct 1, 2014
By: Jill Wechsler
BioPharm International
Volume 27, Issue 10, pp. 8-9
The development of new tr…
Article
Quality by Design—Bridging the Gap between Concept and Implementation
The drive to embed quality-by-design (QbD) principles into the pharmaceutical regulatory framework of the European Union has reached a key point 10 years after the European Medicines Agency (EMA) firs…