How Do You Overcome Bioanalytical Challenges in Cell & Gene Therapy Development?
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Developing cell and gene therapies (CGT) requires navigating a complex landscape of analytical challenges. Whether you are working with AAV, lentivirus, mRNA therapeutics, or novel vectors, the questions you must answer to satisfy regulatory bodies are rigorous.
- How does the product distribute, persist, or express in target and non-target tissues?
- How do you analytically characterize the product for preclinical or clinical use?
At Accelevir, we provide a comprehensive suite of bioanalytical services designed to answer these questions with precision. From early discovery through GLP-compliant studies, our platforms support the full characterization of your therapeutic.
GLP & Non-GLP Biodistribution Studies
Understanding where your vector goes—and where it stays—is critical for safety and efficacy. We offer robust GLP and Non-GLP biodistribution studies utilizing advanced platforms including dPCR (digital PCR), qPCR, and flow cytometry.
Our workflows allow for precise quantification of vector genomes in various biological matrices, helping you map tissue tropism and confirm clearance in non-target organs.
Drug Product Characterization: VCN & Integrity
Defining the quality and potency of your drug product is a regulatory imperative. We provide specialized assays for drug product characterization, ensuring you have a clear picture of your therapeutic before it reaches the patient.
- Vector Copy Number (VCN): Utilizing highly sensitive dPCR workflows to accurately quantify average vector copy numbers per cell.
- Vector Integrity: Leveraging sequencing technologies to assess the structural integrity of your vector and detect potential rearrangements or deletions.
Viral Vector Titration
Accurate titration is essential for dosing and manufacturing consistency. We offer viral vector titration services using both dPCR and flow cytometry. These assays provide precise measurements of physical and infectious titers, allowing for reliable dose-setting strategies.
Transgene Expression Analysis
Beyond delivery, you must confirm function. Our transgene expression assays quantify the expression levels of your therapeutic payload in target tissues. By correlating expression data with VCN and biodistribution results, we help you build a cohesive story of potency and mechanism of action.
Partner with Experts in AAV, Lentivirus, & mRNA
Bioanalytical characterization is not “one size fits all.” It requires a partner with deep expertise across multiple modalities. Accelevir supports a wide range of developers, including those focused on AAV and Lentiviral gene therapies, In vivo CAR-T, mRNA therapeutics, and CRISPR/Base editing.
Ready to characterize your product with confidence? Start your project with Accelevir today.