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

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

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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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.

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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 ApoStream^TM 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