Search results for " small-scale"
Article
Downstream Processing for Cell-Based Therapies
While highly specific labeling separation systems may be suitable within low volume production (proof-of-principle, small-scale studies, or autologous applications), it is extremely unlikely these wil…
Article
Lessons Learned Accelerate Vaccine Development
“Quality by design, high-throughput screening, high-throughput sequencing, small-scale models to simulate large-scale production, artificial intelligence (both simulation and predictive models), and m…
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A Risk-Based Genetic Characterization Strategy for Recombinant CHO Cell Lines Used for Clinical and Commercial Applications
… from a larger-scale preparation, even though the expression plasmid was previously confirmed from a small-scale preparation (mini-prep). Because the issues were discovered and corrected prior to tra…
Article
Framing Biopharma Success in 2016
Corporate restructurings, regulatory initiatives, and biosimilars will shape biopharma development in 2016.
By Rita C. Peters
The US biopharmaceutical industry turned a new page in 2015 when…
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A Bright Future for the Plasma Fractionation Industry
Christophe Carnewal presented their work on qualified small-scale models to reduce the number of conformance batches and a simplified regulatory submission for upscaling and process validation activit…
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Improving PAT for Biologics
Combining such atline analyzers with real-time spectroscopic techniques should allow the effective monitoring of bioreactor farms with small-scale reactors,” he notes. Siemens is also exploring synerg…
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Trends in Single-use Bioreactors
This allows a small-scale continuous perfusion culture to be set up in just minutes, without the hassle of sterilizing or connecting external perfusion devices.
Another example of how single-use…
Article
QbD and PAT in Upstream and Downstream Processing
A key factor to realize the full benefit of QbD is the establishment of robust small-scale model(s) of the upstream manufacturing process. This may be more challenging for certain products resulting i…
Article
Quality by Design: A CMO's Perspective on Gaining Knowledge Faster and Better
From a CMO perspective, the traditional strategy behind process development has largely been to quickly identify target operational values that hit a primary quality target. This type of development s…