Search results for "development"
Article
Scaling Up Novel Therapies
Used almost exclusively for monoclonal antibodies (mAbs), platforms help shorten development times, particularly early in development, Ransohoff says. They also allow manufacturers to leverage perform…
Article
FDA Framework Spurs Advanced Therapies
ISCT also expects the recent approvals to spark considerable investment across all stages of drug development from fundamental research within academia to commercial manufacturing by Big Pharma and co…
Article
Quality by Design: A CMO's Perspective on Gaining Knowledge Faster and Better
This type of development strategy has been intended to generate at-scale product for clinical trials as fast as possible. The resultant operational ranges have traditionally been either very narrow be…
Article
Downstream Processing Continues to Worry CMOs
This year, chromatography products ranked 6 out of 23 new product development areas of interest measured, after sharing the top ranking last year out of 22 areas tracked. Not too surprisingly given th…
Article
Assessing Manufacturing Process Robustness
…
The pharmaceutical regulatory landscape and pharmaceutical development have been reshaped by International Council for Harmonisation of Technical Requirements…
Article
Biopharma Advances Demand Specialized Expertise
The approval of the first biosimilar in the United States, as well as continuing consolidation in the biopharma and contract development and manufacturing markets, are just two indicators of the ongoi…
Article
Q&As with Industry Leaders
Jeanne Linke Northrop, BioPharm International
Nora Ketterer, Manager, Modeling Services, Cytiva
Top Tips for Successful Development of Antibody Chromatography Processes
Jeanne L…
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
Defining Critical Quality Attributes for Monoclonal Antibody Therapeutic Products
Identifying CQAs for a biotech therapeutic is the first and arguably the most difficult step in implementation of quality by design (QbD) for development and production of biopharmaceuticals (3, 4). …
Article
Witnessing Major Growth in Next-Generation Antibodies
A few have already been approved, and many more are in preclinical and clinical development. There are numerous challenges that need to be overcome first, however, and the full impact of next-generati…