Search results for " biologic" in Articles / App Notes
Article
Resolving a bottleneck in screening and characterization of recombinant antibody fragments using Biacore 4000
Antibodies and their derivatives are increasingly important as biotherapeutics, precision diagnostics, and essential tools for biological research. Techniques to screen and characterize large number…
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Vaccine Development Faces Urgency and Challenges
Similarly, Wilson Forsyth, director of quality control at AstraZeneca (AZ) Biologics Global Operations, described a complex two-year process for shifting a vaccine quality control operation from Calif…
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FDA Releases Draft Guidance on Emerging Manufacturing Technology
Requests must be submitted three months prior to a planned application (Investigational New Drug, Abbreviated New Drug Application, Biologics License Application, or New Drug Application) date.
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Best Practices in Qualification of Single-Use Systems
The author discusses the current best practices in technical qualification of single-use systems.
By Weibing Ding, PhD
Single-use technology has been around for approximately two decades if …
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Optimizing Cation-Exchange Chromatography with High-Throughput Process Development for mAb Purification
Purifying these biological products once produced by cells requires a reliable and optimized chromatography process. An advantage in the area of mAbs is the possibility of using a purification platfor…
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Risk Assessment and Mitigation in Biopharmaceutical Manufacturing
…director of quality assurance, and Paul Davis, senior manager of business resilience, at AstraZeneca Biologics to get the latest on performing risk management in biopharmaceutical manufacturing.
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A Bright Future for the Plasma Fractionation Industry
In March 2014, Biogen received its recombinant Factor IX-Fc fusion protein (Alprolix™) approved by FDA, and in December, CSL Behring also submitted a biologics license application (BLA) for the market…
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Vaccine Development and Production Challenges Manufacturers
FDA facilitated licensing by granting “breakthrough” status and accelerated approval for the vaccine candidates, and the Center for Biologics Evaluation and Research (CBER) approved Pfizer’s Trumenba …
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SEC in the Modern Downstream Purification Process
Another benefit of using SEC is that the biological activity of the target of interest is preserved throughout the separation process, particularly if the target of interest requires that its quaterna…
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Fermentation for the Future
Notably, the technology can be used to produce proteins incorporating non-natural amino acids and for the production of challenging biologic substances, such as difficult-to-fold proteins. In addition…