Search results for "flexible"
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Biopharma Says It Has an Evolution in New Technologies and Processes
This week, the Process Development Forum interviews Rita Peters, editorial director of BioPharm International, about Interphex 2018.
At the 2018 Interphex trade show in New York City in April…
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Modern Manufacturing Key to More Effective Vaccines
Modern Manufacturing Key to More Effective Vaccines
Accelerated development of new preventives raises challenges for efficient CMC evaluation and production.
By Jill Wechsler
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Single-Use Chromatography: Adapting to Manufacturing Scale
Single-use technologies offer the flexibility needed to meet the demands of multiproduct facilities. The capital investment is lower, and substantial time savings can be made when eliminating cleani…
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Applying GMPs in Stages of Development
The earlier the product phase is, the more flexible your requirements. As the product approaches Phase III, the board requirements should mimic commercialization requirements. The concept is the GMPs …
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Industry Adoption of Single-Use Systems Remains Low
One of the company’s most important investments was the 2012 acquisition of Xcellerex, a supplier of manufacturing technologies, including FlexFactory for biologics, a centrally automated, flexible bi…
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FDA Framework Spurs Advanced Therapies
Greater clarity on the application of existing regulations will accelerate development of cell and gene therapies.
By Cynthia A. Challener
Ibreakstock/Shutterstock.co…
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QbD Improves Cell-Culture Process Control
…les the biomanufacturer to move from a quality-by-testing approach to a QbD approach, which is more flexible (1). By applying advanced sensor systems combined with mathematical modeling techniques, o…
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Connected Polishing and Concentration Under One Automation Method
Chromatography and tangential flow filtration (TFF) steps are traditionally performed as separate unit operations in downstream bioprocessing. This work aims to demonstrate the capability of the UNICO…
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Development of Purification for Challenging Fc-Fusion Proteins
Development of Purification for Challenging Fc-Fusion Proteins
This study outlines methods for an alternative protein-polishing process for challenging proteins.
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Manufacturing Standards Key to Advancing Cellular and Gene Therapies
Manufacturing Standards Key to Advancing Cellular and Gene Therapies
FDA works with industry on strategies for assuring high-quality regenerative medicines.
By Jill Wechsler
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