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Cell and Gene Development From R&D to Manufacturing 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 clinical, regulatory, manufacturing and commercial challenges.


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.

We have built the largest advanced therapy manufacturing footprint in the world.  Through our partnerships with the leaders in cell and gene therapy, we have pioneered best practices that speed product to market.

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
6 in tech ops capital investments managed

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.

  • 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.

  • 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.

  • manufacturing

    Manufacturing Solutions

    You’ll start with the team that led the industrialization of the most notable FDA-approved advanced therapies—and built the world’s largest cell and gene therapy manufacturing footprint. We help cell and gene therapy trials achieve operational excellence, accelerating speed to market for life-changing therapies.

  • 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.


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
  • 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

Manufacturing services for cell therapy and gene research

Due diligence & business strategy

  • Due diligence technical assessments
  • Landscape and market analysis
  • Training and education
  • Modeling (qualitative and quantitative)
  • Capacity planning
  • "Make vs. buy" or "build vs. buy" assessments
  • Cost of goods analysis
  • Facility build planning
  • CDMO selection
  • Site selection

Project scheduling & controls

  • CAPEX planning and portfolio management
  • Detailed schedule development
  • Budgeting and estimating
  • Cost controls and forecasting
  • Critical path scheduling and analysis
  • Risk management
  • Earned value and resource productivity analysis
  • Capital Expenditure and Facility Projects
  • Facilities optimization and process modeling


Commissioning, qualification & validation

  • CQV planning and development
    • Process and analytical equipment, utilities and facilities
  • Lead and support all types of validation:
    • Equipment validation
    • Process validation
    • Cleaning validation
    • Steaming validation
    • Computer system Validation
    • Laboratory equipment validation
    • Environmental monitoring performance qualification
  • Program development and maintenance
  • Paperless validation implementation and support

Quality, regulatory & compliance

  • Policies and procedures ("SOPs") development 
  • Quality management systems implementation (e.g. EMS, LMS, EAM, CMMS)
  • Supplier quality management program implementation
  • Data integrity and Part 11 compliance
  • Auditing services
  • CMO/CDMO selection and management,
    quality agreements, person in plant
  • Quality risk assessments
  • NC and CAPA program development
  • Regulatory strategy and submissions
  • Audit preparation and support
  • Compliance remediation
  • Health authority inspection readiness

Operational readiness

  • Integrated schedule development
  • Policies and procedures development
  • Computerized Maintenance Management System (CMMS) implementation
  • Batch production record development
  • Calibration/preventative maintenance procedure development
  • Spare parts determination
  • Staffing model development and staff augmentation
  • Training documentation development
  • Finite scheduling

Owner’s representative, project management and SME backfill

  • Program & project management
  • Program development
  • Drug developer owner's representation:
    • Design build and construction firms
    • Vendors or equipment suppliers
    • CMO/CDMOs
  • Project Management Office (PMO) creation and management
  • Capital project management

Capital project, facility builds & tech transfers

  • Capital project planning and management
  • Program and project management
  • Facility design support
  • CDMO selection and management
  • Vendor selection and management
  • Equipment selection and procurement
  • Scope, schedule and budget management
  • Technical transfer planning and management
  • Backfill Key Technical Roles

Automation & controls

  • Quality by Design & GAMP principles
  • Preliminary, conceptual & detailed facility design (greenfield & brownfield)
  • URS / FS / DS documentation
  • Vendor and equipment selection, procurement & management  
  • Change control ownership 
  • Automation and integration
  • Part-11 compliance  
  • Facility utilities: mechanical, electrical & plumbing  
  • System owner & process engineering 
  • Manufacturing Execution System (MES) implementation
  • Paperless Batch Production Record system implementation

Supply chain

  • Supply chain strategy
  • ERP/MRP system implementation
  • MRP master data development and optimization
  • Capacity and long-term planning
  • cGMP Warehouse validation
  • Operational readiness
  • Cold chain and ultra-cold chain compliance

Asset life cycle management & operations

  • Environmental Health and Safety (EHS) program creation and evaluation
  • Asset life cycle management 
  • Reliability and maintenance 
  • Decommissioning 
  • Training
  • Periodic requalification
  • Performance metrics and KPI dashboards

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