Experience across the entire process of gene therapy development
Leadership from the lab, to trials and through successful production
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Why talk to Precision about your gene therapy project? Perhaps because we are purpose-built to solve the complex challenges posed by precision medicines like gene therapies. We’ve partnered with leading biotech and pharma companies to develop FDA and EMA approved treatments. Our services span from comprehensive biomarker assay suites to CRO services to leading the build and expansion of over 60 gene and cell therapy facilities.
Purpose-built to deliver on the promise of gene therapy
Gene therapy development has a wide range of challenges that include a dynamic regulatory environment, pre-existing and treatment-induced immunity to the viral vectors, intricate manufacturing processes, locating and recruiting patients.
Precision’s transformational approach to preclinical development, clinical trials and manufacturing ensures that your project has the comprehensive services and expertise needed to create solutions for every gene therapy development challenge, from IND-enabling assays to commercialization.
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cell, gene and novel therapies industrialized
12
sample processing locations worldwide
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rare disease clinical trials and trials for 100+ orphan projects
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IVD and CDx global regulatory submissions and registrations
Solving complex challenges in gene therapy development
Proven expertise in gene therapy along with integrated development capabilities helps compress timelines and find efficiencies in every stage. Precision accelerates gene therapy development from the late pre-clinical phase through commercialization.
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Specialty Lab Services
- NAb and TAb assays
- Immunogenicity testing e.g. ELISpot and Fluorospot
- Viral capsid and transgene expression assays
- Distribution and persistence assays
- Central laboratory testing services for global trials
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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
- End-to-end services for the entire manufacturing life cycle
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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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Regulatory Consulting
- Well versed in EMA and FDA regulatory requirements
- Access to FDA officials to review proposed approaches
- Able to advise on the latest safety, efficacy and quality standards
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PBMC Processing Services & Clinical Sample Processing
- Clinical sample kit development
- PBMC processing at 11 labs in five continents
- Global sample logistics, shipping and biostorage
- Real-time sample data analytics
- virtual Sample Inventory Management (vSIM)
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CDx / LDT Development
- Co-development timelines of treatment and CDx
- TAb and NAb companion diagnostic development
- Extensive experience with multiple AAV serotypes
- Access, reimbursement, and channel analysis and strategy
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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.
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in tech ops capital investments being managed
Optimizing Successful Gene Therapy Development
Optimizing successful development of viral vector gene therapies, gene therapy trials and companion diagnostics
Top leadership ratings for a CRO in the ISR Report 2024
Our latest insights on gene therapy development
Navigating Cell and Gene Therapy Acquisitions: A Strategic Blueprint
