Search results for " biosimilar"
Article
The Outlook for CMO Outsourcing in 2019
… is expected to increase in coming years, as new classes of products receive approvals, particularly biosimilars and cellular and gene therapies. In the next five years, the number of approved biosim…
Article
Process Chromatography: Continuous Optimization
“For biosimilars, it is necessary to produce a comparable pattern of protein variants. That requires removal of closely related byproducts in proteins, such as charge or glycosylation variants,” Bulpi…
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Innovative Therapies Require Modern Manufacturing Systems
More biosimilars are poised to come to market in 2016 following FDA approval of the first such therapy in 2015. At the same time, though, the development of such innovative and targeted therapies heig…
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Use of Multivariate Data Analysis in Bioprocessing
Establishing comparability forms an integral and crucial aspect of biosimilar development. In fact, the underlying essence of biosimilar development is that if the manufacturer is able to demonstrate …
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A Q&A With Dr. Anurag Rathore About the Future of QbD, Part I
Even biosimilar manufacturers based outside North America and Europe are also implementing QbD. But every company is in the process of trying to figure out better (as in more efficient with respect to…
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A Look Ahead at BioPharma Manufacturing and Regulation
ANALYTICAL METHODS
BioPharm: Priority 3 in the strategic plan also calls for developing new analytical methods, including those to determine similarity between reference products and biosimilars…
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Preparing for the Future Visions and Insights for Biomanufacturing
Yet, new market dynamics, such as growing competition from biosimilars and niche drugs targeting smaller patient populations, are reshaping how drugs are produced and sold.
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Biopharmaceutical Market in Asia: Q&A with Günter Jagschies, Strategic Customer Relations Leader, Cytiva
India and China have a strongly growing and well-funded biopharmaceutical industry focusing primarily on biosimilar proteins with several hundred projects in the pipeline. India is also in a leading p…
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Tools and Solutions for Separation of Charged mAb Variants
A biosimilar is an almost identical version of an originator product. To attain regulatory approval, a comparable quality to the reference product in terms of efficacy, purity, and safety should be …
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Preclinical Evaluation of Product Related Impurities and Variants
This, however, highlights the need for a comprehensive, meticulous, and rigorous preclinical evaluation of safety and efficacy of a biosimilar product to assuage any risks associated to the abbreviate…