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Cell and Gene Therapy Development From R&D to CDx to Market

Experience in every stage for complex cell and gene therapy studies and production Contact us

Because of the inherent complexity of cell and gene development, Precision mobilizes a made-to-fit team of cross-functional, multidisciplinary experts who are study tested and help our clients solve pre-clinical, clinical, regulatory and commercial challenges.

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Driving cell and gene therapy innovations

Our experience developing multiple types of cellular therapies gives us the understanding to develop bespoke solutions for each therapeutic cell type including CAR-T cells, stem cells, and tumor-infiltrating lymphocytes. With leadership in gene therapy immunogenicity, a regulatory team that coordinates therapeutic and companion diagnostic strategy, and a focus on executing end-to-end clinical trials, Precision is well-positioned to guide successful gene therapy development.

10 Cell, gene and novel therapies industrialized
20 Cell therapy trials started in the last 5 years
50 R&D projects supported in the last 2 years
30 in investments raised for biotech in the last 5 years

A transformational approach to delivering cell and gene therapies

Few solution providers for cell and gene therapies can offer the pioneering expertise of Precision. Fewer still have integrated the specialized capabilities that can help compress timelines and find efficiencies throughout a development process that will almost certainly encounter scientific and logistical complexities.

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    clinical-trial-services

    Clinical Trial Development

    From pre-clinical through registration studies, our experts are leaders in the advancement of cell and gene therapy development, leveraging the research interests of the sites to build clinical enthusiasm, supporting the logistical complexities of these trials, and addressing complex safety issues.

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    specialty-lab-services

    Specialty Lab Services

    Cell and gene therapy research requires specialized expertise to support successful translation from the bench to the clinic. We deliver, with a broad array of both established and Precision-engineered platforms targeted specifically to the needs of cell or gene therapy development, and thought leaders who are helping shape the therapeutic and regulatory landscape.

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    companion-diagnostic

    Companion Diagnostics

    The success of your cell or gene therapy ultimately relies on accurate identification of appropriate candidates for treatment. These treatments often require a Companion Diagnostic (CDx). Precision has the required specialized clinical development, biomarker assay, regulatory strategy and commercialization capabilities.

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Clinical trial experience and services for cell and gene therapy development

Cell and gene study experience

Cell therapy –Autologous and allogeneic
  • CAR-T cells
  • Stem cells
  • Tumor-infiltrating lymphocytes
  • TCR Therapy
  • Cell Therapy
  • Other
Gene therapy
  • CRISPR
  • Multiple AAV serotypes
  • Lentivirus
  • Exosomes

Global sample processing and logistics

  • Customized kit manufacturing
  • Site support and lab manuals
  • Real-time sample processing (assays and PBMCs)
  • Virtual Sample Inventory Management
  • Global biobanking (tissue and cells)
  • Quality standards and certifications (CAP, ISO, GxP)
  • Transport management and 24/7 tracking and reporting

Trial design and execution

  • Clinical development strategy and planning
    • Study design and protocol development
    • Manufacturing logistics
    • Toxicity Management Guidelines
  • Cell and gene therapy experience navigating CBER, CDER, and ex-US regulators, as well as site-level IBC requirements for cell and gene therapy
  • Experienced Investigators with documented experience in cell and gene therapy
    • Investigational Product Receipt and Processing Plan
    • Logistical oversight of supply chain management
    • Labelling requirements
  • Robust data-driven monitoring strategy
  • Rapid AE identification and management
    • Ongoing patient safety and data trend analysis
  • Data Safety Monitoring Boards
  • Data collection strategy
    • eCRF development
    • Data visualizations
    • Scientific and medical remote data review
  • Biometrics/biostatistics and oversight
  • CDISC programming and documentation

Specialty lab services for gene and cell therapy clinical research

Cell therapy lab capabilities

  • Molecular characterization of CAR T-cells using the nCounter® CAR-T Characterization Panel
  • Cell expansion, distribution and persistence assays using ddPCR or flow cytometry
  • Cytokine, chemokine, and pro-inflammatory assays
  • Sequencing for aberrant CRISPR events
  • Measurement of minimal residual disease using flow cytometry or NGS
  • Liquid biopsy using ApoStreamTM for CTC and rare cell capture and enrichment
  • IHC and multiplex IF for immunophenotyping and tumor profiling
  • Central laboratory testing services for global clinical trials
  • Epigenetic markers for immune cell lineages

Gene therapy lab capabilities

  • NAb and TAb assays (exploratory to CLIA, CE Mark or CDx)
  • Immunogenicity testing e.g. ELISpot and Fluorospot
  • Viral capsid and transgene expression assays
  • Distribution and persistence assays
  • Central laboratory testing services for global clinical trials

Companion diagnostics services for cell and gene therapies

CDx development

  • TAb and NAb companion diagnostic development
  • Cell-based, ELISpot, and immunoassay capabilities
  • Complete analytical studies under full design control
  • Cell bank development and maintenance
  • Extensive experience with multiple AAV serotypes

Regulatory services for CDx, IVDs and LDTs

  • FDA pre-submissions and market clearances
  • IDE and SRD submissions
  • 510(k), de novo, and PMA submissions
  • Access, reimbursement, and channel analysis and strategy
  • QMS development

Industry insights from cell and gene therapy experts

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