Search results for " meeting"
Article
New Therapies Present Scaling Challenges
New Therapies Present Scaling Challenges
Manufacturing differences between traditional mAb therapies and newer biotherapeutics dictate whether processes should be scaled up, scaled out, or use an al…
Article
Using Software in Process Validation
Using Software in Process Validation
Software systems can help validate pharmaceutical manufacturing and steer the most appropriate design of processes in the right direction.
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Article
Best Practices for Selecting a Top-Quality Cell Line
Irina Shi - Stock.Adobe.com
Leveraging automation and a step-by-step approach are keys to success.
By Cynthia A. Challener
Cell lines determine the performanc…
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 …
Article
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…
Article
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…
Article
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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Resource
Affinity, Stockholm, Sweden
This meeting has a long tradition, where scientists and engineers from academia and industry meet to exchange knowledge in the field of affinity technology, molecular recognition and its application i…
Article
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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Article
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…