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Sartorius Stedim BioOutsource Introduces Assays for Testing Biosimilarity of Three Leading Biologics

Sartorius Group

New ready-to-use assays enable quick and simple generation of precise biosimilar comparability data

22 Mar 2016
Lois Manton-O'Byrne, PhD
Executive Editor

Product news

Sartorius Stedim Biotech (SSB), an international leading supplier for the biopharmaceutical industry, presents a range of ready-to-use assays for testing Actemra, Stelara and Lucentis biosimilars. The new assays, launched by SSB’s subsidiary Sartorius Stedim BioOutsource, will allow biopharma manufacturers to generate accurate comparability results rapidly and cost-effectively.

Utilizing its extensive expertise in the development, optimisation and qualification of a wide range of different types of binding assays and immunoassays, the ready-to-use assays have been developed to ensure accurate comparability results for biosimilars to Actemra, Stelara and Lucentis. The new assays available include: Actemra IL-6R Neutralisation Bioassays; an Actemra IL-6R Binding ELISA; Stelara IL-12/IL-23 Binding Assays; a Stelara C1q Binding Assay; a Stelara Neutralisation bioassay; Lucentis VEGF Binding Assays and a Lucentis VEGF Neutralisation Bioassay.

These pre-developed assays complement BioOutsource’s existing portfolio of assays and expands the number of molecules the company can now support to more than nine molecules. The availability of pre-qualified off-the-shelf assays provides biosimilar developers the opportunity to quickly and cost effectively test a wide range of biosimilars utilising assays from just one trusted supplier.

Additionally, as BioOutsource has its own in-house R&D department, it is continually adding to its portfolio of assays. Therefore, if an assay is not listed, scientists can contact the firm to discuss its availability, or use the company’s expert services to configure an assay to meet their specific requirements.

Dr Daniel Galbraith, Chief Scientific Officer of Sartorius Stedim BioOutsource stated: “We’re delighted to bring new assays for testing Actemra, Stelara and Lucentis biosimilars to market. This means we can now offer biopharma companies a comprehensive range of ready-to-use assays, which they can trust to determine precise comparability results and accelerate their biosimilar drug development.”

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Assay AssemblyAssay Assembly is technique used in drug discovery to develop assays to test the cytotoxicity, genotoxicity, or other activities of a compound on a cell. Assay assembly requires chip assembly, a delivery system and a detection and analysis method. Beneficial features of assay kits or automated systems include high-throughput, high speed and sensitivity and low signal to noise ratio.Cell-Based AssaysCell-based assays are used to monitor the presence, quantity and activities of a desired cellular analyte including drug molecules or biomarkers. This can reveal information on cell health (apoptosis, cytotoxicity, viability and proliferation assays), cell metabolism, cell migration and cell signaling mechanisms. Find the best cell-based assay products, kits and equipment with our peer reviewed product directory: compare products, check customer reviews and receiving pricing direct from manufacturers.BiologicsBiologics are medical products derived from living organisms, including vaccines, gene therapies, and monoclonal antibodies. These treatments are key to modern healthcare, especially in oncology and autoimmune diseases. Explore biologics research tools in our peer-reviewed product directory; compare products, check reviews, and get pricing directly from manufacturers.BiosimilarsBiosimilars are very similar versions of approved and authorized medicines. Clinically inactive components will have minor differences, but there are no significant differences between the biosimilar and the original product in terms of potency, purity and safety.BiopharmaceuticalsBiopharmaceuticals are proteins and other compounds (such as nucleic acids) produced by living organisms that have uses as therapeutics or for in vivo diagnostics. The most well known example of a biopharmaceutical product, and the first to be approved for therapeutic use, was recombinant human insulin.ManufacturingManufacturing is the production of merchandise for use or sale using labor and machines, tools, chemical and biological processing, or formulation.Assay DevelopmentThe process of proving an assay to be sensitive with respect to the target is known as assay development. The assay should be able to characterize novel compounds and measure the potency of these compounds against a validated biological target.

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