Search results for "development"
Article
Operational Excellence: More Than Just Process Improvement
By embracing efficiency and quality, biopharmaceutical organizations can work better and achieve better work.
Life-sciences companies face more pressure than ever to reduce costs and increase eff…
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Prescribing Caution for Biosimilars
Until recently, there was no pathway for the development and approval of biosimilar products in the United States. The US Food and Drug Administration is currently developing such a pathway. Even afte…
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Considerations in depth filter scale-up
In this work, we present scalability data across a full range of process development-scale, pilot-scale, and manufacturing-scale depth filter capsules. Analysis includes pressure profiles, turbidity a…
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Boosting biopharma resilience: The need to shift focus and increase collaboration
Biopharma Resilience is declining. The 2023 Global Biopharma Resilience Index from Cytiva offers insights into the current state of the industry, shining a light on both areas of strength an…
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A Look into Biologic Scale-Up Strategies
Optimizing cell-culture processes for monoclonal antibody (mAb) production is a key factor in scaling up manufacturing to commercial levels. To maximize cell-culture output, strategy is requir…
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Xcellerex™ X-platform bioreactor live virtual demo
We designed Xcellerex™ X-platform bioreactors to meet your process needs today and in the future. Whether in pilot or cGMP facilities, the modular and application-based approach improves cell …
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How to Use Multiwell Plates With Manual Operation
During process development, aspects like robustness, scalability, and GMP production come into play. FDA initiatives such as quality by design (QbD) put demands on better process understan…
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Current Trends in Host Cell Protein Detection for Biologics Manufacturing
Commonly accepted HCP analytical methods, the challenges of HCP assay, and recommendations on what can easily be accomplished in-house and when it may be better to outsource.
Read more here…
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See a chromatography modeling software in action
Mechanistic models use computer simulations to decrease the number of experiments you need during process development.
The simulations are based on known physiochemical phenomena involved in ch…
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Chromatography innovations for the diverse antibody pipeline
To support development of new therapeutic possibilities, manufacturing and process development technologies must also evolve. For antibody variants, platform purification protocols for conve…