Search results for " meeting" in Articles / App Notes
Article
Driving Improved Access to Biosimilars
… several US congressional hearings on drug prices and greater focus on biosimilars, including an FDA meeting devoted exclusively to the future of biosimilars for insulin.
Since 2015, when FDA …
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Tools and Processes for Mature and Emerging Therapies
…ipment manufacturers and contract manufacturing organizations debated the challenges associated with meeting bioprocessing manufacturing capacity demands for traditional biologic-based drugs, such as…
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Single-Use for Downstream Chromatography: Benefit or Hindrance?
Available technology may not always be adequate to meeting a specific facility’s needs. For example, not all downstream bioprocessing steps are available with single-use technology, and those that are…
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A Look at the Affinity Chromatography Landscape
A Look at the Affinity Chromatography Landscape
New ligands are being developed to meet the separation and purification needs of next-gen biologics.
By Cynthia A. Challener
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A Look into the Future of Biopharmaceutical Quality
A Look into the Future of Biopharmaceutical Quality
Quality experts share insights on what the future may hold regarding regulatory quality requirements for biopharmaceuticals.
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Understanding Validation and Technical Transfer, Part 3
Process monitoring and capability studies are used to predict the ability of a process to produce a product meeting pre-established quality attributes. An adequately designed and controlled process is…
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CoAs Help Secure the Supply Chain
CoAs Help Secure the Supply Chain
Certificates of analysis can be used to monitor the reliability of products and their suppliers.
By Susan J. Schniepp, distinguished fellow at…
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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
While widely adopted in upstream production processes, what is required to move single-use technologies into downstream manufacturing scale?
This article discusses strategies for meeting the ever…
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3rd BioProcessing Asia Preview: Q&A with John Curling
The 3rd BioProcessing Asia conference will take place November 12-15, 2018 on Langkawi, Malaysia. This week, Bioprocess Development Forum talks with John Curling, Conference Chair, about the upcomin…