Search results for "biosimilar" in Articles / App Notes
Article
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…
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N-Glycan Analysis of Biotherapeutic Proteins
Of these, mAbs represent a large proportion of biotherapeutic glycoproteins and account for approximately half of the biopharmaceutical market, a trend that is set to continue with the advent of biosi…
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Drug Quality Key to Innovation and Access
Similarly, modern, agile, and reliable production systems that adhere to standards and ensure data integrity are vital for development and access to biosimilars, cellular and gene therapies, complex d…
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A Second Modular Biopharma Facility Opens: KUBio in Hangzhou
To bring advanced biosimilar products to the Chinese market quickly, Pfizer’s Global Biotechnology Center will make use of Cytiva’s KUBio advanced modular manufacturing solution. KUBio modules …
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Applications of Surface Plasmon Resonance for Detection of Bispecific Antibody Activity
FDA, Guidance for Industry: Scientific Considerations in Demonstrating Biosimilarity to a Reference Product (Rockville, MD, Apr. 2015).
19. C. Gassner et al., J. Pharm Biomed Anal. 102…
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Drugs, At What Cost?
Competition generated through established biosimilar pathways will drive down the high costs of biologics in Europe, the US, and some emerging countries. However, in markets with less rigorous IP prot…
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Milestones and Moderate Progress in 2012 Drug Approvals
The product is already marketed in Europe as Tevagrastim where it is classified as a biosimilar (to Amgen's recombinant G-CSF, Neupogen). However, it was assessed and approved in the US as an original…
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A Look into Biologic Scale-Up Strategies
Optimizing cell-culture processes for monoclonal antibody (mAb) production is a key factor in scaling up manufacturing to commercial levels. To maximize cell-culture output, strategy is requir…