Services

Strategic. Scientific. Integrated.

Comprehensive analytical solutions designed to de-risk development and accelerate your path to patients

Experienced leadership and strategic guidance to navigate the complex analytical landscape and drive your program forward.

• Provide interim or fractional leadership for Analytical Development organizations
• Advise on analytical strategy, CQA identification, and product characterization across development stages
• Develop analytical roadmaps aligned with program milestones and regulatory strategy
• Oversee CRO, CDMO, and external laboratory activities supporting analytical development and method transfer

Comprehensive strategies and platforms that link product characteristics to biological function and regulatory expectations.

• Design phase-appropriate analytical control strategies aligned with regulatory expectations
• Establish analytical platforms for potency, flow cytometry, molecular assays, and immunoassays using AQbD principles
• Develop analytical lifecycle documentation including analytical target profiles, method plans, SOPs, and technical reports
• Build analytical frameworks linking product phenotype, potency, and biological function

Comprehensive assay development and characterization services spanning cell-based potency, flow cytometry, molecular, and immunoassay platforms.

• Cell-based potency assays: develop MoA-reflective assays supporting release and process characterization
• Flow cytometry panels for CAR expression, transduction efficiency, and cellular phenotype
• Molecular assays (qPCR/ddPCR) for vector copy number, integration titer, and identity testing
• Immunoassays (ELISA, Ella, multiplex) for impurities, purity, and cytokine profiling

Risk-based comparability strategies and comprehensive lifecycle management from method qualification to continuous improvement.

• Design risk-based comparability strategies for process changes, scale-up, and technology transfer
• Develop analytical bridging strategies and statistical comparability frameworks
• Define phase-appropriate method qualification and validation strategies
• Support specification setting, analytical method monitoring, and critical reagent lifecycle management

Integrated stability study design and regulatory CMC support from IND through BLA submissions and inspections.

• Design stability strategies and stability-indicating analytical methods
• Develop stability study protocols aligned with regulatory expectations
• Author and review analytical and CMC sections for regulatory submissions (IND and BLA)
• Prepare teams for regulatory interactions and pre-approval inspections (PAI)