46 BioProcess International INDUSTRY YEARBOOK 2012–2013 ADVERTORIAL 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 physicochemical properties, biological activity, immunochemical properties, purity, and impurities — is necessary to establish the safety and efficacy profile of a given product (as per ICH Q6B guidelines). Cell culture–based potency assays are often the preferred format for determining biological activity because they measure the physiological response elicited by a product and can generate results within a relatively short period of time — unlike typical animal-based assays. Cell-based potency assays are also often the only functional assays used for product-release and stability programs. Other uses of cell-based potency assays include qualification of internal reference standards, characterization of process intermediates, and support of changes in a product- production process. Choosing the right partner for the development of a cell- based potency assay is critical. Our scientists have a wealth of experience in a number of techniques and types of products. With unmatched experience, we provide a dedicated turn-key service from bioassay development and validation to cGMP batch release, helping to accelerate your time to clinic and meeting your testing program needs. WHY CHOOSE EUROFINS LANCASTER LABORATORIES FOR CELL-BASED POTENCY ASSAYS? • We have a success rate of >95% on cell-based potency assay transfers. • We achieve ±25% or better RSD on all assays. • We have more experienced PhDs than any other contract laboratory. • We offer the largest breadth of services and facility capacity for cGMP biologics stability and release in the industry. TYPES OF CELL-BASED POTENCY ASSAYS 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, [email protected], www.lancasterlabspharm.com. Managing Cell-Based Potency Assays From Development to Lifecycle Maintenance Contract Services

Managing cell based potency assays

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46 BioProcess International Industry yearbook 2012–2013 advertorial

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 physicochemical properties, biological activity, immunochemical properties, purity, and impurities — is necessary to establish the safety and efficacy profile of a given product (as per iCH Q6B guidelines). Cell culture–based potency assays are often the preferred format for determining biological activity because they measure the physiological response elicited by a product and can generate results within a relatively short period of time — unlike typical animal-based assays. Cell-based potency assays are also often the only functional assays used for product-release and stability programs. other uses of cell-based potency assays include qualification of internal reference standards, characterization of process intermediates, and support of changes in a product-production process.

Choosing the right partner for the development of a cell-based potency assay is critical. our scientists have a wealth of experience in a number of techniques and types of products. With unmatched experience, we provide a dedicated turn-key service from bioassay development and validation to cGMP batch release, helping to accelerate your time to clinic and meeting your testing program needs.

Why Choose eurofins LanCaster Laboratories for CeLL-based PotenCy assays?

• We have a success rate of >95% on cell-based potency assay transfers.

• We achieve ±25% or better RSD on all assays.• We have more experienced PhDs than any other contract

laboratory. • We offer the largest breadth of services and facility

capacity for cGMP biologics stability and release in the industry.

tyPes of CeLL-based PotenCy assaysvarious 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, [email protected], www.lancasterlabspharm.com.

Managing Cell-Based Potency Assays From Development to Lifecycle Maintenance

Contract Services