Search results for " advanced therapies"
Article
Maximum Output Starts with Optimized Upstream Processing
Evolution in bioprocessing
The increasing diversity of advanced therapies has driven upstream manufacturing processes to evolve, according to Philip Vanek, CTO at Gamma Biosciences. “The latest …
Article
Commercial Production of Gene Therapies Using Suspension or Adherent Cell Lines
This article will explore the traditional path from the laboratory to the clinic and how the fixed-bed technology provides an alternative solution to meet commercial demands.
By Alex Chatel and …
Article
Tools and Processes for Mature and Emerging Therapies
New technologies and thought trends provide innovative biomanufacturing approaches for a range of therapies.
By Rita Peters
Conference sessions and new technology introductions at recent t…
Article
Transformative Medicines Challenge FDA and Manufacturers
Transformative Medicines Challenge FDA and Manufacturers
New gene therapies and combination products require innovative regulatory approaches.
By Jill Wechsler …
Article
Downstream Processing for Cell-Based Therapies
Rafiq, Fernanda Masri
With increasing numbers of advanced therapies—including cell and gene therapies—entering early- and late-stage clinical development, significant focus has been directed towar…
Article
Reimagining Affordable Biosimilars
Advances in preclinical development play a crucial role in reducing cost for developing biosimilars.
By Anurag S. Rathore, Narendra Chirmule, and Himanshu Malani
Drug development is …
Article
A Look into the Future of Biopharmaceutical Quality
However, new quality regulations are likely to be required to keep up with the development of new advanced therapies, including gene and cell therapy and tissue engineering. Some of these are autologo…
Article
Biosimilars to Drive Modern Manufacturing Approaches
Reliable, high-quality products require innovative analytics and production.
By Jill Wechsler
As more biosimilars gain market approval in the United States, and manufacturers launch addition…
Article
Innovative Therapies Require Modern Manufacturing Systems
FDA and industry see progress and challenges in bringing cutting-edge medicines to patients.
By Jill Wechsler
FDA set a 19-year record in 2015 in approving more new drugs and biologics, and …
Article
Single-Use Technologies Prove Effective for Viral Vector Process Development
Looking ahead
Overall process robustness is the most crucial consideration, asserts Cameau, and work continues across the industry to overcome the challenges to commercialization of advanced thera…