Search results for " scale-up"
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Perfusion in the 21st Century
The use of smaller bioreactors, even for commercial production, reduces the time and cost required for scale-up (7). Finally, perfusion can accommodate the shift toward multiproduct facilities, which …
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A Q&A with Eric Langer: CMOs Embrace New Technology
What patterns are you seeing in the use of single-use systems for scale-up and commercial production for CMOs versus drug companies that manufacture their own products?
Commercial-scale bioprocess…
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Innovative Therapies Require Modern Manufacturing Systems
At the same time, though, the development of such innovative and targeted therapies heightens the importance of establishing production systems and processes capable of fast scale-up of high-quality c…
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Taking a “Development-by-Design” Approach to Cell Therapies
Invetech has been working on cell therapy process scale-up automation for more than 10 years and has successfully completed projects in North America, Europe, and Asia for companies that include Argos…
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Quality Systems Key to Lifecycle Drug Management
This plan will allow the original reviewers to evaluate initial scale-up and formulation changes for more innovative products. Post-approval changes for biotech therapies will continue to be managed b…
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Modern Manufacturing Systems Key to FDA Quality Initiative
Such approaches, the authorities predict, could reduce waste, prevent drug shortages, and avoid the scale-up and production challenges that can delay final approval of innovative breakthrough therapie…
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Continuous Manufacturing: A Changing Processing Paradigm
…users, and there are also concerns surrounding process development control, contamination risks, and scale-up potential of traditionally batch-based systems (1). In addition, there is some trepidatio…
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Continued Process Verification for Biopharma Manufacturing
QbD recognizes that scale-up and industrial-scale commercial manufacturing experience provide knowledge about the process and the suitability of raw materials used. FDA’s January 2011 process validati…
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Q&As with Industry Leaders
Putrich, BioPharm International
John Scibetta, Advanced Chromatography Specialist, Cytiva
Q&A: Oligonucleotide Synthesis in Process Development and Scale-Up
Megan Manzano, BioPh…
Article
Manufacturers Struggle with Breakthrough Drug Development
27, 2014) that breakthrough drug development requires information on critical quality attributes, potential scale-up strategies, comparability exercises, and validation plans. FDA will want to know ho…