Search results for " expression"
Article
Managing Residual Impurities During Downstream Processing
“With the diversification of expression systems, the immunoassay approach may become increasingly difficult to follow, and regulation around alternative methods could become necessary,” she asserts.
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Poster
Adenovirus production in a single-use stirring tank bioreactor system
Adenovirus vectors are attractive delivery systems for vaccines and cancer treatment. Scalable and cost-efficient production technologies are needed to enable manufacturing of safe and efficacious c…
Article
Being Thorough When Transferring Technology
Communication and taking the time to develop the process are key to successful transfer and scale up of biologics.
By Susan Haigney
Editor's note: The following is an extended version of the…
Article
Cost Considerations Drive Lean Technology in Biopharmaceutical Manufacturing
Conditions of growth, the type of expression system, the formulation of the final product, and packaging decisions also affect the essential character of the product.
Adam Elhofy, chief science of…
Article
Reconciling Sensor Communication Gaps
By Angelo DePalma, Ph.D.
Process analytical technology (PAT), quality by design, and individual company- or process-centric quality initiatives are driving the development of bioprocess sensors …
Article
Biopharma in 2016: Higher Quality Drugs, Less Expensive Manufacturing
The year ahead is expected to be marked by increased biosimilar development, lower drug prices, and better quality drugs.
The global biopharmaceuticals market was valued at $162 billion in 2014 a…
Article
Biosimilars to Drive Modern Manufacturing Approaches
The manufacturer also has to carefully develop analytical methods and the expression system for the construct and host cell. These activities can help refine the manufacturing process, where incorpora…
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
Safety Drives Innovation in Animal-Component-Free Cell-Culture Media Technology
Advances in cell culture media technology have helped achieve safer biologics.
By Tom Fletcher, Holden Harris
Regulatory expectations for cell-culture-based biologics production processes ch…
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…