Cell and Gene Therapy CRO – Analytics Driving Safe and Effective Therapies
At ProtaGene, we combine decades of expertise in cell and gene therapy analytics with a deep understanding of regulatory requirements. As a trusted cell and gene therapy CRO, we provide integrated analytical development across all phases of gene therapy and cell therapy development. Our goal is clear: deliver reliable data, ensure patient safety, and accelerate the path from discovery to clinical trials and approval.
Expertise Across the Gene and Cell Therapy Lifecycle
From early research and preclinical development to pivotal gene therapy trials, our teams support clients with a broad range of analytical capabilities. We design and validate robust assays that meet the highest scientific and regulatory standards. By combining molecular bioanalysis, viral vector characterization, and immune response monitoring, we provide the insights needed to guide critical decisions at every stage of development.
Our multidisciplinary teams, including scientists, regulatory experts, and medical directors, work collaboratively to address challenges in oncology, rare disease, and other therapeutic areas. This integrated approach is highly advantageous in managing complex cGMP requirements, regulatory submissions, and trial safety considerations.
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We’re well-staffed and positioned to support your most complex cell and gene therapy programs.
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Integrated Cell and Gene Therapy Analytics
At ProtaGene, we provide end-to-end cell and gene therapy CRO services that combine advanced analytics, regulatory expertise, and deep scientific knowledge. Our integrated approach ensures the development of safe, effective, and compliant therapies across the full lifecycle—from discovery through late-stage clinical trials.
Genome and Gene Editing Analysis
Precise evaluation of gene editing technologies such as CRISPR, TALEN, and ZFN is critical for advancing next-generation therapies. Our analytics identify both on-target modifications and potential off-target events, delivering actionable insights into efficacy and patient safety.
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Comprehensive on-/off-target analysis to validate genome editing strategies
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Immune repertoire profiling to assess immune responses and safety considerations
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Advanced NGS platforms providing regulatory-compliant datasets for clinical submissions
Vector Characterization
Reliable vector characterization is central to the success of cell and gene therapy development. ProtaGene applies state-of-the-art techniques to assess vector integrity, potency, and safety, ensuring regulatory readiness and therapeutic performance.
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Detailed evaluation of viral vectors, including empty/full particle ratios
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Identification of critical quality attributes (CQA) essential for regulatory approval
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Robust assay design supporting both preclinical research and cGT trials
Gene Expression Quantitation
Understanding the expression of therapeutic genes is key to demonstrating efficacy. Our teams deploy advanced technologies such as LC-MS, qPCR, and RNA-Seq to quantify gene expression with precision and reproducibility.
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Quantitative analysis of transgene expression in target tissues
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Correlation of expression data with therapeutic efficacy and safety
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Regulatory-compliant workflows for preclinical and clinical phases
Advancing Gene Therapy Safety with Industry-Leading Expertise
Ensuring patient safety is at the core of ProtaGene’s mission as a leading cell and gene therapy CRO. Our teams combine decades of experience in analytical development with a proven track record of supporting complex gene therapy trials and cell therapy programs. By applying robust assays, advanced viral vector analytics, and expertise across diverse therapeutic areas—including oncology and rare diseases—we deliver the insights needed to safeguard efficacy and meet stringent regulatory requirements.
Through early engagement with regulatory agencies and close collaboration with medical directors, regulatory experts, and multidisciplinary teams, we provide the strategic guidance necessary to navigate challenges in manufacturing processes, patient recruitment, and cell expansion. From the development of monoclonal antibodies to next-generation gene therapy products, ProtaGene supports sponsors with an integrated, cross-functional approach that accelerates progress while ensuring compliance.
Diverse Cell and Gene Therapeutic Platform Expertise
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Capsid-based Vectors
- AAVs (Multiple Serotypes and Engineered Vectors)
- Novel Systems
- Adenovirus
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Complex, Envelope Vectors
- Lentivirus
- Gammaretrovirus
- Novel Viruses
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Non-viral Vectors
- Polynucleotide (DNA/RNA) Formulations
- Lipid Nanoparticles
- Transposons
- Plasmids
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Genetic Editing
- TALEN
- CRISPR/Cas9
- Zinc-finger Nucleases
- Other Systems
Why ProtaGene?
- Unique development expertise in both protein and gene analytics
- Broad single-vendor analytical offering from discovery to market
- Significant scale of expertise & multi-region facility presence
- Best-in-class quality, supporting robust regulatory packages
- Reputation and delivery trusted by leading biopharma companies
- Uniting scientific excellence and compliance to assist your ATMP development
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Talk to Our Experts
Partner with ProtaGene for your next Cell and Gene Therapy project. Get in touch today to discuss how our gene therapy analytics and cell therapy CRO expertise can advance your next study.
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