Search results for "Adaptation" in Articles / App Notes

Article The Evolving Role of Starting Materials in Cell and Gene Therapy
Understanding the optimal operating limits of critical reagents and methods can speed process adaptation and product re-validation. Cell-therapy starting material sourcing is a tremendous challe…

Article Tools and Processes for Mature and Emerging Therapies
New technologies and thought trends provide innovative biomanufacturing approaches for a range of therapies. By Rita Peters   Conference sessions and new technology introductions at recent t…

Article New HiScale™ 10/40 for Scale-Down Studies
Cytiva is pleased to announced the new HiScale™ 10/40. HiScale 10/40 column is especially suitable for scale-down studies used in, for example, viral clearance evaluation in downstream processing. …

Article Successfully Moving Regulated Data to the Cloud
In light of recent FDA guidance on data integrity, the challenges and benefits of using the public cloud to deploy and use data management software are discussed. By Stuart Ward …

Article Putting Viral Clearance Capabilities to the Test
Process understanding and careful assessment of risks are essential in developing viral clearance programs. By Rita C. Peters nobeastsofierce/Shutterstock.com  …

Article Making the Move to Continuous Chromatography
Making the Move to Continuous Chromatography Early adopters are benefiting from lower costs and increased productivity. By Cynthia A. Challener Tashatuvango/Shu…

Article 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…

Article Reliability Rooms and the Move to Proactive Supply Chain Management
Reliability Rooms and the Move to Proactive Supply Chain Management Cross-functional reliability rooms identify risk and planning metrics, provide insights for production forecasts, and predict tren…

Article Evaluating Surface Cleanliness Using a Risk-Based Approach
Evaluating Surface Cleanliness Using a Risk-Based Approach Rinse sample analysis or visual inspection can be correlated to surface cleanliness to replace surface sampling. By Elizabeth Rivera…

Article Impact of Media Components on CQAs of Monoclonal Antibodies
The authors review how media components modulate the quality of monoclonal antibody products.  By Anurag Rathore, Rajinder Kaur, Dipankar Borgayari  Recombinant protein products have…

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