Search results for " control"
Article
Modeling the Degradation of mAb Therapeutics
Armed with this knowledge, developers can better predict and control aggregation by optimizing timeframes and environmental conditions (10).
A number of protein aggregation models already exis…
Article
Ensuring Viral Safety of Viral Vaccines and Vectors
Ensuring Viral Safety of Viral Vaccines and Vectors
Viral vaccines and viral vectors used in biotherapeutic applications carry the risk of microbial contamination, which must be addressed.
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Sensitive and Reproducible SPR-Based Concentration and Ligand-Binding Analyses
This article focuses on concentration assays associated with late-stage development and biotherapeutic drug chemical manufacturing and control.
Read the article here.
Article
Get Acquainted with How SPR Technology is Used for Better Protein Characterization
Stay up-to-date with our new e-book on the latest in SPR technology and use in the fields of process development and product quality control.
Download the free e-book on Better Biotherapeutic Char…
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Biopharma Says It Has an Evolution in New Technologies and Processes
Another challenge is maintaining sanitary conditions in a continuous process; the control of bioburden, while basic, is fundamental to success, said Galliher.
Implementing automation technology ca…
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Making the Move to Continuous Chromatography
Some systems come with dynamic control functionality—process analytical technology (PAT)—that enables the continuous chromatography unit operation to better adapt to changes in feed concentration (whe…
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Modern Manufacturing Key to More Effective Vaccines
CBER also encourages manufacturers to meet with FDA staff to address chemistry, manufacturing, and controls (CMC) issues before filing an application.
Robin Levis, deputy director of OVRR’s Div…
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Connected Polishing and Concentration Under One Automation Method
This work aims to demonstrate the capability of the UNICORN™ system control software to integrate these unit operations to eliminate intermediate hold steps thereby releasing resources and reducing ov…
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Manufacturing Standards Key to Advancing Cellular and Gene Therapies
Participants explored strategies for analytical method development, assay validation, product characterization, specification setting, and for establishing relevant manufacturing controls for these hi…
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Development and Future of Protein A Chromatography Technology: Q&A with Jonathan Royce, Business Leader Chromatography Resins, Cytiva
Now, 1M NaOH can in fact be used, improving the bioburden control, and the binding capacity is now up to 80 g/L. With an increased binding capacity and new high-flow agarose bead design, the productiv…