Gene and Cell Therapy Development
Accelerate advanced therapy development with our custom potency assays, AAV-specific safety platforms, and mechanism-of-action reflective cell-based solutions backed by GMP expertise.
Gene and Cell Therapy Development
Gene and Cell Therapy Development
Gene and cell therapies present unique challenges in potency, safety, and regulatory compliance. Robust assays ensure product consistency, confirm mechanism of action, and identify potential immune risks such as complement activation.
How we can help
We provide specialized solutions for gene and cell therapy development, including custom potency assays, adeno-associated virus (AAV) safety testing, and mechanism-of-action (MOA)-reflective bioassays. Our expertise helps you meet regulatory requirements and accelerate innovation.
From custom potency assays and MoA-reflective bioassays to AAV-specific services for neutralizing antibody (NAb), total antibody (TAb), and complement activation, we provide tailored solutions backed by GMP-compliant CRO support.
Our gene and cell therapy solutions can be used for:
- Regulatory Compliance: Supports FDA and EMA requirements for advanced therapies.
- Safety Assurance: Detects immune responses and complement activation for AAV-based products.
- Custom Solutions: Tailored potency assays for gene-modified cell therapies.
Our Gene and Cell Therapy Solutions
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CELL-BASED BIOASSAYS
Purpose‑built cell-based assays quantify function that directly reflects the engineered mechanism of action, from receptor signaling to cytotoxicity. Methods are delivered with qualification pathways, controls, and system suitability criteria to support release and stability.
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COMPLEMENT ASSAYS
We evaluate classical, alternative, and lectin activation to identify complement‑mediated risks during AAV administration. Panels are standardized for consistency and are suitable for candidate triage, eligibility screening, and clinical monitoring.
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CELL-BASED BIOASSAYS
iLite® cells and engineered systems provide sensitive readouts for transduction, expression, and downstream signaling. Assay ready formats shorten development time and improve precision across sites.
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GENE THERAPY ASSAYS
Our NAb platforms quantify neutralizing antibodies against AAV vectors to assess potential impacts on transduction efficiency and therapeutic performance. Assays include controls and reference materials to support longitudinal studies and regulatory submissions.
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GENE THERAPY ASSAYS
TAb platforms measure total antibody levels to provide a complete immunogenicity profile for AAV-based therapies. These assays help monitor immune response over time and include validated controls for consistent, reproducible results.
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GENE THERAPY ASSAYS
Our complement activation assays evaluate complement activation associated with AAV infusion, a critical factor for safety assessment and risk mitigation. Delivered with reference standards, these assays support regulatory filings and long-term safety monitoring.
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CELL-BASED BIOASSAYS
We design reporter cells matched to your vector, target, or signaling cascade to create high‑fidelity potency methods. Cells are delivered with performance data and protocols, enabling rapid integration into development pipelines.
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CRO SERVICES
Our GMP services cover potency, safety, and stability with complete documentation and QA oversight. Support includes method lifecycle management and preparation for inspections.
Contact our team of experts
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