B2S Life Sciences has extensive expertise in the design, generation, characterization and life cycle management of custom, biological reagents to create robust assays for regulated bioanalysis to support investigations of PK/TK, immunogenicity, and novel biomarkers. Some of our unique critical reagent competencies include:
- Decades of experience in protein purification, including a variety of chromatographic options.
- Access unique tools for detailed characterization of proteins and conjugates
- Provide a Reagent Characterization Form (RCF) for all critical reagents that includes detailed information about product purity, concentration, and biological activity.
- Capability to scale critical reagent production in sufficient quantity to avoid the need for producing new lots during In-study analysis of test samples
- Design, production and characterization of matched antibody pairs for optimization of PK/TK and quantitative biomarker assays
- Generation and characterization of ADA positive controls
- Purification and characterization of Biomarker reference standard to support biomarker and CLIA assessments
- Long-term storage of reagents in temperature-controlled environment (ambient, 4, -20, -80°C)
- ‘First-of-a-kind’ Inventory management tool (LCM+) to allow clients with on-line secure access to their reagent critical information.
- Periodic retest dates to ensure quality and updating of RCF
- Support for reagent management and global distribution
Our critical reagent design and development is a comprehensive technical collaboration between our highly experienced staff scientists and our partners that’s driven by client needs. Our emphasis is always on mutual success, with a reagent strategy meticulously tailored to specific client needs. Under the supervision of a technical expert, clients can expect to be guided in the following sequence:
Assay Development and Qualification
Spanning over 100 years of applied experience, B2S Life Sciences’ leadership team possesses a breadth of knowledge around biotherapeutic drug development activities. As a team, we strive to design an assay that enables our clients to make data-driven decisions that will optimize outcomes.
B2S offers a range of services from early-stage assay development (including an optimized matched-pair of antibodies), to supporting regulatory-compliant bioanalysis PK/PD assessments. These include, but are not limited to:
- Binding kinetics, clone selection, Ab pair-selection, and epitope mapping/binning
- Quantitative method development (PK, biomarker)
- Immunogenicity method development (ADA, competitive LBA Nab, cell-based Nab)
- Coated assay plate generation/development (i.e. ELISA, ECLIA, etc.)
- Critical Reagent Pack (Pharma-Grade Kit) development
- CMC supporting assay development
- Oversight of method transfer to a GLP contract research organization for sample analysis
- 3 BioTek® ELISA readers (Synergy H1™ and Synergy HT™)- UV-Vis, fluorescence, luminescence, etc.
- MSD® QuickPlex™ (ECL)
- FortéBio OctetRED96™ and HTX™ BLI instruments- Binding kinetics, clone selection, and epitope mapping/binning
- Luminex® FLEXMAP 3D® (Multiplexing immunobead platform)
- Beckman Coulter Navios Flow Cytometer (Cell-based/NAb assays)