Search results for "Biosimilars"
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…
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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…
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Optimizing your Cell Culture Process to Improve Productivity
Jeanne Linke Northrop: What industries would need these analytical testing for cell culture?
Mary Szorik: We mainly work with biopharma companies that are producing therapeutic proteins, biosim…
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Pandemic Alters Policies and Practices for Drug Development and Regulation
There were important advances in biosimilars, moreover, with the approval of the first two interchangeable products (1).
Despite these accomplishments, FDA officials had to contend with publ…
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Maximum Output Starts with Optimized Upstream Processing
Demand for biosimilars is also increasing. The requirements associated with COVID-19 vaccine manufacturing are placing further pressure on upstream manufacturing capacities.
“The situation is evol…