Potency and QC Lot-Release Testing Product Solutions
Providing Functional, MOA-based Bioassays with Superior Lot-to-lot Reproducibility
Cell-based potency assays are critical tools to measure the efficacy of a drug during stability and potency testing. Potency assays are initiated in the early drug development stage to measure the biologic's intended biological effect and mechanism of action (MOA) being analyzed. Quality control (QC) lot-release testing, intended for late-stage drug release programs, involves assays that ensure consistency with high lot-to-lot reproducibility. Given that the process of drug discovery and development is time consuming, complex, and expensive, implementing a physiologically relevant assay platform from the early development phase to late-stage drug release programs such as QC lot release can prove to be highly valuable.
Eurofins DiscoverX® develops qualified, MOA-reflective cell-based assays (bioassays) that are phase-appropriate and meet the requirements of specific therapeutic development stages, including potency and QC lot-release testing. These bioassays are derived from stable cell lines and provide a simple, thaw-and-use approach that alleviates assay passage-to-passage variability associated with cells derived from continuous cell culture. Packaged with ready-to-use cryopreserved cells, plates, and all the reagents and documents needed, Eurofins DiscoverX bioassay kits offer the ideal solution for your therapeutic development programs. These kits are rigorously tested to meet ICH (International Council for Harmonization) requirement guidelines and qualified with marketed biologic drugs or reference standards, allowing you to confidently de-risk your potency testing program and accelerate your therapeutic development timelines.
Product Highlights
- Physiologically Relevant — Bioassays qualified with marketed biologic drugs or reference standards using ICH guidelines
- Phase-appropriate Solutions – Complete ready-to-use, functional cell-based assay kits of unsurpassed quality for potency and QC lot-release testing
- Deep Expertise – Over two decades of experience in developing cell-based assays to support your specific therapeutic development stage
- Full Support – Dedicated team for end-to-end assay transfer and long-term support of your commercial release and stability programs at CRO/CDMO sites
Eurofins DiscoverX Provides Cell-based Assay Product Solutions and Full CRO/CDMO Support
| Eurofins DiscoverX | CRO/CDMO Site | |||
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| Stable Cell Lines > | Ready-to-Use Bioassay Format > | Qualified Method with Marketed Drug > | Assay Transfer Support to CRO/CDMO Site > | Assay Validation for GMP Lot Release Testing > |
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ICH-Based Assay Qualification
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Long-Term Support
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Eurofins DiscoverX offers the largest portfolio of cell lines and cell-based assays for characterization studies, potency testing in QC lot-release, neutralizing antibodies (NAbs) detection, and stability programs. Cell-based bioassay kits are easy to implement in any lab from pre-clinical development to QC lot release, and qualified with marketed biologic drugs or reference standards. Global technical support and field application scientist teams provide end-to-end assay transfer support for you at contract research and contract development and manufacturing organizations (CRO/CDMO). GMP = good manufacturing practices.
Global Programs using Eurofins DiscoverX Bioassays for Potency, Stability, and NAb Testing for Drug Release
Choose from Industry’s Largest Portfolio of Ready-to-use Bioassays
Access the continually expanding portfolio of over 60 MOA-reflective, ready-to-use bioassay kits or consider Eurofins DiscoverX Custom Development Capabilities to meet your specific assay needs with the same level of robustness as off-the-shelf assays. With decades of cell-based assay development and cell line engineering expertise, utilize this service to generate custom bioassays or further screen and validate bioassays with your molecule using systematic qualification protocols.
MOA-reflective Bioassays
According to industry guidelines published by the US Federal Drug Administration (FDA), an MOA-reflective, physiologically-relevant assay is essential to accurately report a drug product’s potency and stability. Eurofins DiscoverX bioassays are specifically designed to measure the proximal molecular events occurring directly as a consequence of receptor activation, thus providing assay readouts that truly represent the MOA of the drug candidate. The target- or MOA-based bioassays are optimized with a reference ligand. These assays can be readily implemented in development programs for drug candidates (biologics or small molecules) that use the same MOA for the target.
Qualified Bioassays
Eurofins DiscoverX’s bioassay development strategy is driven by industry standards. The MOA-reflective, functional cell-based bioassays are developed and optimized following systematic qualification studies to evaluate key attributes defined by ICH Technical Requirements for Pharmaceuticals for Human Use and United States Pharmacopeia (USP) guidelines. These attributes include accuracy, precision, linearity, range, specificity, robustness, and stability-indicating properties that demonstrate consistency in assay performance and generate reliable measurements that can be correlated with the clinical outcomes of the drug candidate.
Obtain End-to-end Support for Assay Transfers to CRO/CDMO Sites for Your QC Lot Release Program
Eurofins DiscoverX’s global Field Application Scientist team provides extensive technical support and consultation with availability for onsite trouble shooting or training. For CRO/CDMOs, consider the Certification Program designed to qualify CRO/CDMO’s to run Eurofins DiscoverX’s bioassays.
Documentation Support
Eurofins DiscoverX is committed to delivering high-quality products for supporting drug development programs from discovery to lot release. The Eurofins DiscoverX Quality Management System has oversight by a Quality Assurance (QA) Manager and support by the company President. The bioassays contain QA-reviewed product documentation, including a lot-specific Certificate of Analysis, Batch Traceability records, Safety Data Sheets, Marker Rescue documents, and other biosafety documents to support regulatory filings.
Critical Reagents Management Programs
Eurofins DiscoverX has in place strategies for long-term product support, including a two-tiered analytical cell banking program that ensures uninterrupted supply of critical reagents (bioassay cells) for the life of your drug program. This program delivers long-term lot-to-lot reproducibility, reducing the burden for lot bridging studies, and provides flexible inventory management enabling customized production of large dedicated lots, flexible storage options, as well as customized shipment schedules. Learn more about this Cell Banks for Bioassay Program to ensure long-term assay reproducibility with the production of bioassay cells from dedicated, well-characterized, and established cell banks.
Additional programs including technology transfer are available to help with your commercialization risk mitigation strategy. Contact us to learn more.
Alpana Prasad, Ph.D. Director, Innovations and Strategic Partnership
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Read MorePresenter: Jane Lamerdin, Ph.D., Director of R&D, Eurofins DiscoverX
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Read MoreProducts & Custom Development Capabilities.
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Ready-to-use kits for biologics characterization, MOA confirmation, NAbs detection, stability studies, & potency testing
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Program designed to qualify CRO/CDMOs to run Eurofins DiscoverX bioassays for client downstream therapeutic efforts
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Ensure long-term assay reproducibility with the production of bioassay cells — critical reagents for cell banks
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Stable cell lines, cell pools, frozen cells, & primary effector cells for a broad range of target classes
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Custom cell lines, kits, assays, & protein development capabilities optimized to fit your requirements
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