Search results for " biologics"
Article
Platform Technologies Improve Protein Expression
Platform technologies facilitate development and accelerate commercialization of protein therapeutics.
By Cynthia A. Challener
Speed to market is essential in the biopharmaceutica…
Article
Process Chromatography Selection for Downstream Processing Applications
Separation Technologies
BioPharm: What are the most commonly used separation technologies for biologics that are not monoclonal antibodies (mAbs)?
Björkman (Cytiva): If one excludes mAbs, then…
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…
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A Risk-Based Genetic Characterization Strategy for Recombinant CHO Cell Lines Used for Clinical and Commercial Applications
In addition, the authors wish to recognize and thank Lonza Biologics (Slough, UK) for the licensing of and permission to modify the GS-CHO expression system.
References
1. J.M. Reichert, MAbs. 7…
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Adherent Cell Culture in Biopharmaceutical Applications: The Cell-Detachment Challenge
The necessity to detach cells from a culture substrate during cell harvesting remains one of the most challenging steps in a cell-culture process.
By Marcos Simon, Juan J. Giner-Casares
Cell…
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Framing Biopharma Success in 2016
The Center for Biologics Evaluation and Research (CBER) approved more than a dozen new biologics, vaccines, blood products, and diagnostics. These numbers, and types of drugs approved, indicate that t…
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GMP Challenges for Advanced Therapy Medicinal Products
Finalizing GMP requirements and quality standards for the development, manufacture, and clinical testing of ATMPs in the EU is proving to be a complex task.
By Sean Milmo
A consultation period…
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Advanced Technologies Facilitate Scale-up and Technology Transfer
FDA’s focus on the need for updates is creating both opportunities and challenges for biologics manufacturers involved in the scale-up and transfer of production technologies. Single-use and modular t…
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Ligand-Binding Assays and the Determination of Biosimilarity
During biosimilar development, it is necessary to demonstrate that the physicochemical properties, efficacy, and safety (e.g., immunogenicity) of the biosimilar are similar to those of the …
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Biopharma Manufacturers Respond to Ebola Crisis
There has been broad interest in using tobacco and other plants to produce vaccines and biologics for multiple indications, and further testing of ZMapp provides an opportunity to evaluate biopharming…