Search results for " development" in Articles / App Notes
Article
Quality by design for biotechnology products—part 1
Therefore, this paper offers guidance and interpretation for implementing QbD for biopharmaceuticals, from early-phase development steps such as identifying critical quality attributes and setting spe…
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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…
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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…
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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…
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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…
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Assessing Manufacturing Process Robustness
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The pharmaceutical regulatory landscape and pharmaceutical development have been reshaped by International Council for Harmonisation of Technical Requirement…
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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…
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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…
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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). …