Search results for " biologics"
Article
Designing a Biomanufacturing Facility Incorporating Single-Use Technologies
Asking the right questions is crucial to establishing a facility design.
By Peter Genest, John Joseph
The benefits of adopting single-use technologies in the production of biopharmaceuticals…
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…
Article
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…
Poster
Modes of controlling charge variant distribution in Mab production
The characteristics of a biological drug, for example, charge variant profile, are determined to a large extent by the upstream expression system and conditions, but can also be influenced by the pu…
Article
FDA Releases Draft Guidance on Emerging Manufacturing Technology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.
Article
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 …
Article
Optimizing Cation-Exchange Chromatography with High-Throughput Process Development for mAb Purification
Optimization of each phase in a chromatographic cycle has a positive impact on productivity.
By Anna Grönberg
An important area of focus for the biopharma industry is the elucidation and dev…
Article
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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Article
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…
Article
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 …