Search results for " biosimilar"
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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…
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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…