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Managing cell based potency assays

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Transcript of "Managing cell based potency assays"

  1. 1. Contract ServicesManaging Cell-Based Potency AssaysFrom Development to Lifecycle MaintenanceE stablished at the forefront of current good manufacturing practice (cGMP) cell-based potency assay contract testing, Eurofins Lancaster Laboratories, Inc. provides assistance in all aspects ofbioassay development, validation, method transfer, and long-term assay maintenance. Characterization of a biologicalproduct — which includes the determination of Choosing the right partner for the development of a cell-physicochemical properties, biological activity, based potency assay is critical. Our scientists have a wealth ofimmunochemical properties, purity, and impurities — is experience in a number of techniques and types of products.necessary to establish the safety and efficacy profile of a given With unmatched experience, we provide a dedicated turn-keyproduct (as per ICH Q6B guidelines). Cell culture–based potency service from bioassay development and validation to cGMPassays are often the preferred format for determining biological batch release, helping to accelerate your time to clinic andactivity because they measure the physiological response meeting your testing program needs.elicited by a product and can generate results within arelatively short period of time — unlike typical animal-based Why Choose Eurofins Lancasterassays. Cell-based potency assays are also often the only Laboratories for Cell-Based Potency Assays?functional assays used for product-release and stability • We have a success rate of >95% on cell-based potencyprograms. Other uses of cell-based potency assays include assay transfers.qualification of internal reference standards, characterization of • We achieve ±25% or better RSD on all assays.process intermediates, and support of changes in a product- • We have more experienced PhDs than any other contractproduction process. laboratory. • We offer the largest breadth of services and facility capacity for cGMP biologics stability and release in the industry. T ypes of Cell-Based Potency A ssays Various types of cell-based assays, based on the mechanism of action of the product, have been used to support product licensing and commercial release. Some common types of cell- based assays used to characterize recombinant proteins and monoclonal antibodies include: • Proliferation assays • Cytotoxicity/apoptosis assays • Reporter gene assays • Cell surface receptor binding assays • Assays to measure induction or inhibition of functionally essential protein or other signal molecule, such as phosphorylated proteins, enzymes, cytokines, and cyclic adenosine monophosphate (cAMP). • Cliff Schorr is director of biopharmaceutical business development, 2425 New Holland Pike, PO Box 12425, Lancaster, PA 17605, 1-717-682- 8975, cschorr@lancasterlabs.com, www.lancasterlabspharm.com.46 BioProcess International Industry Yearbook 2012–2013 advertorial

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