Search results for " biopharms" in Articles / App Notes
Article
The Tide Stays High
Robust venture capital investment gives CDMOs and CROs a positive outlook for 2017.
By Jim Miller
A year ago, the outlook for contract services was a little uncertain. Equity markets’ appeti…
Article
Improving Process-Scale Chromatography
Advances in technology are increasing the productivity and efficiency of commercial-scale chromatography bioprocesses.
By Cynthia Challener, PhD
Chromatography is a crucial step in the purif…
Article
Establishing Acceptance Criteria for Analytical Methods
Knowing how method performance impacts out-of-specification rates may improve quality risk management and product knowledge.
By Thomas A. Little, PhD
To control the consistency and quality o…
Article
Real Time Continuous Microbiological Monitoring
Laser-induced fluorescence, a rapid microbiology method for real-time airborne particle and microbial monitoring, enhances sterility assurance in pharmaceutical manufacturing.
By Claudio Denoya …
Article
Modeling Bioreactor Performance
Model effectiveness is determined by the quality and composition of the data inputs.
By Cynthia A. Challener
Bioreactor design, including the geometry of the tank and impeller and the locati…
Article
Innovation vs. Capacity: How CMOs Compete
The strategies of an innovation-driven CMO may be different than a capacity-driven CMO.
By Jim Miller
While industry participants and observers talk about the “CMO industry,” they know that …
Article
Perfusion in the 21st Century
Quality, flexibility, and cost savings are driving use of perfusion technology in biosimilars manufacturing.
By Bruce Lehr, Delia Lyons
Cell-culture technology for biopharmaceutical manufact…
Article
Downstream Processing Continues to Worry CMOs
CMOs are working hard to improve performance by investigating new technologies for filtration and purification.
By Eric S. Langer
Downstream processing continues to be a significant pain poi…
Article
Generating a Fully Processed Antibody
The authors outline cell-line development and process scale-up for an antibody program in which the antibody requires additional processing by a site-specific enzyme for correct functionality.
B…
Article
Analysis of Glycosylation in Biosimilars
A step-wise process is used to characterize glycans and understand the functioning of a molecule for biosimilar development.
The structures of protein drugs such as monoclonal antibodies are mad…