Experts in the Intricacies of Cell Therapy Development

End-to-end experience in delivering a broad range of cell therapies Contact us

Precision was born from a desire to support innovators in precision medicine. Your cell therapy project will be enriched by our collective experience in cell therapy development. Our services span from award-winning CRO to comprehensive biomarker assay services to pioneering builds of GMP compliant cell therapy facilities from 5000 to 500,000 square feet.

Helping innovators deliver on the promise of cell therapy

Cell therapy development is at the forefront of advanced therapeutic modalities, especially in oncology research, but the intricacies can complicate the development process.

Precision’s experience developing a broad range of cell therapies, including CAR T cells, stem cells, autologous and allogeneic products, and tumor-infiltrating lymphocytes, gives us insight into the challenges of cell therapy as a whole, as well as how development of each of these cell types differ. We understand the isues each program can face and our integrated, multidisciplinary team can create a bespoke solution appropriate for your project. We are working with leaders in cell therapy innovation and take pride in the FDA approvals we’ve supported. Bringing breakthrough treatments to patients in need is our purpose and passion.

25 countries with cell therapy trials

10 cell, gene and novel therapies industrialized

11 worldwide labs with PBMC processing

20 cell therapy trials in the last 5 years

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Clinical Trial Design
- Full service CRO for global trials
- Patient recruitment and enrollment: specialization in rare disease
- Expertise with current regulatory environment
- Operational excellence in cell therapy study conduct
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Specialty Lab Services
- Immune Monitoring
- Bioanalysis
- Genomics
- IHC/mIF and Pathology
- Liquid Biopsy
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Manufacturing Solutions
- End-to-end services for the entire manufacturing life cycle
  - Planning and designing
  - Building and testing
  - Deploying and operating
  - Scalability and flexibility
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Biospecimens
- PBMCs—healthy and disease state
- Leukopaks
- Mobilized leukopaks
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PBMC & Sample Processing

Sample processing with expertise in PBMC isolations from labs across 5 continents

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CDx Development & Commercialization
- Biomarker discovery and assay development
- Preclinical planning and strategy
- Assay development into single-site PMA CDx with full regulatory and market support
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Expertise in cell therapy trials

For cell therapy trials there is a keen demand for high-quality, efficient, well-run studies that enable teams to move rapidly in an iterative development cycle. Our experienced team recognizes the nuances involved and prepares trial strategies that address safety, site selection, training, patient recruitment and logistics.

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Scientific capabilities support cell therapies in the lab

Precision supports cell therapy development with a complete suite of biomarker assay services including assay development, validation and implementation to support every phase of your cell therapy project. Our team includes thought leaders in immunogenicity testing that are helping shape the regulatory landscape.

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shot of sterile pharmaceutical manufacturing laboratory

Industrializing novel and complex therapies

Precision has vast experience in designing and building GMP-compliant cell and gene therapy facilities, using cutting-edge modular, emerging bioreactor, and single-use technologies. Our manufacturing playbook—which has been used by the leading cell and gene therapy organizations—has led to the development of the largest and most mature ATMP manufacturing footprint in the world.