1. Contract Services
Managing Cell-Based Potency Assays
From Development to Lifecycle Maintenance
E
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 of
bioassay development, validation, method transfer, and long-
term assay maintenance. Characterization of a biological
product — 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 of
immunochemical 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-key
product (as per ICH Q6B guidelines). Cell culture–based potency service from bioassay development and validation to cGMP
assays are often the preferred format for determining biological batch release, helping to accelerate your time to clinic and
activity because they measure the physiological response meeting your testing program needs.
elicited by a product and can generate results within a
relatively short period of time — unlike typical animal-based Why Choose Eurofins Lancaster
assays. 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 potency
programs. 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 contract
production 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.
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