Search results for " development"
Article
Application of Quality by Design to Viral Safety
This approach uses the concepts laid out in the International Conference on Harmonisation of Technical Requirements of Pharmaceuticals for Human Use (ICH) guidelines, Q8 Pharmaceutical Development, Q9…
Article
Bracing for a Future Wave of Advanced Therapies
Rich development pipeline
ARM’s industry evaluation shows that, across North America, Europe, and Asia Pacific in 2023, the field of CGTs saw more than 2500 developers throw their hat into the rin…
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Remote Monitoring and Big Data Advance Upstream Automation
Automation is necessary to achieve these goals, according to Amy Doucette, global head of pharma solutions engineering and business development for the automated products group of Applied Materials. “…
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The Evolving Role of Starting Materials in Cell and Gene Therapy
Critical quality attribute identification/assay development: Identify and develop assays for critical quality attributes, potency assays—overestimate testing needs!
Methods/equipment qualific…
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FDA Seeks to Enhance Manufacturing of Cell and Gene Therapies
He acknowledged that the logistics of manufacturing autologous cells can be particularly challenging, and that limited capacity in cell lines stymie efforts to meet the demand for product development.…
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Generating a Fully Processed Antibody
By Gregory Bleck, Dona York, David Rabuka
The number of more complex biopharmaceuticals in development continues to increase. These include molecules such as virus-like particle (VLP) vaccines, pr…
Article
Microbiological Testing: Time is of the Essence
Challener
Effective microbiological testing during biopharmaceutical drug development and manufacturing is crucial for ensuring sterility, determining antimicrobial effectiveness, detecting microbi…
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Fermentation for the Future
Drivers of new technology development in microbial fermentation are similar to those for cell-culture processes and include reducing costs, increasing efficiency/productivity, and enhancing quality, s…
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QbD and PAT in Upstream and Downstream Processing
McKnight, PhD, principal engineer, late stage cell culture, BioProcess Development, Genentech; Anurag Rathore, professor, Indian Institute of Technology (IIT) Delhi; Frederic Girard, CEO, Spinnovation…
Article
Technology Innovations Improve Process Chromatography Performance
Recent developments in process chromatography have addressed challenges in downstream separation and purification and led to improved bioprocessing.
Current challenges
The biopharmaceutical ind…