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.
10
cell, gene and novel therapies industrialized
12
sample processing locations worldwide
50
rare disease clinical trials and trials for 100+ orphan projects
350
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
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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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
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
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
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
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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
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
Optimizing Successful Gene Therapy Development
Download this practical, FDA-aligned guide to 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
Case Study: Rapid Startup Phase 1 Cardiomyopathy CRISPR Gene Therapy
