Search results for "Biosimilars" in Articles / App Notes
Article
Biopharmaceutical Market in Asia: Q&A with Günter Jagschies, Strategic Customer Relations Leader, Cytiva
Competition, in particular in the biosimilars field, is fierce to say the least with around 100 companies looking at the same short list of about ten different drugs. The economics of manufacturing in…
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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
Preclinical Evaluation of Product Related Impurities and Variants
The approaches for sample preparation of preclinical evaluation of safety and efficacy are addressed taking into consideration the s…
Article
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
Surface plasmon resonance is helping define bispecific antibodies, the next-generation of biopharma therapeutics.
By Robert Karlsson
Abstract
Biotherapeutic antibodies are still the larg…
Article
Drugs, At What Cost?
Biosimilars account for less than 0.5% of biologic spending in mature markets; in emerging markets, non-original biologics represent more than 10% of all biologics spending.
The mix of total gl…
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Milestones and Moderate Progress in 2012 Drug Approvals
First gene therapy and plant-based expression vector products approved in 2012.
In terms of product approvals, the past year can be considered reasonably successful. Twelve biopharm…
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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…