Search results for "biologic"
Article
Designing a Biomanufacturing Facility Incorporating Single-Use Technologies
Safety and time considerations
The ability of operators to safely work with biologic and potentially hazardous materials at any stage during the process is a key facility design consideration. Kno…
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FDA Releases Draft Guidance on Emerging Manufacturing Technology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
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…
Article
Risk Assessment and Mitigation in Biopharmaceutical Manufacturing
…irector 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.
R…
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 …