Cell & Gene Therapy Bioanalytical Services
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Accelerating AAV, Lentiviral, and mRNA Programs from Discovery to the Clinic.
Read More22 Dec
 |
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Molecular & Genomic Testing
HIV Reservoir & Virology
Immunology
Sample Processing & Biobanking
Therapeutic Modalities
Accelerating AAV, Lentiviral, and mRNA Programs from Discovery to the Clinic.
Read MoreIn immuno-oncology and autoimmune drug development, knowing if a drug works is only half the battle. You also need to know how it is shaping the patient's immune system. Is it expanding the right T-cell subsets? Is it triggering the intended functional activity?
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The next generation of CAR-T therapy is moving in vivo, utilizing Lipid Nanoparticles (LNPs) and mRNA to engineer immune cells directly inside the patient. While this approach promises to democratize access to cell therapy, it introduces a unique set of bioanalytical challenges—from tracking transient mRNA expression to monitoring innate immune activation.
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In the rapidly evolving landscape of cell and gene therapy, the margin for error is non-existent. As therapies move from preclinical models to human clinical trials, the need for absolute quantification of genetic material becomes critical. Traditional qPCR, while useful, often lacks the sensitivity and precision required for the complex matrices and low-abundance targets found in clinical samples.
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For developers of biologics, cell therapies, and vaccines, "How immunogenic is my drug?" is one of the most critical questions in the development pipeline. An unwanted immune response can compromise safety, alter pharmacokinetics, and neutralize therapeutic efficacy.
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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.
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The success of a clinical trial hinges on the quality and integrity of its data. Every sample, every assay, and every result informs critical decisions that impact timelines, budgets, and ultimately, regulatory approval. At the heart of this complex process lies a pivotal decision: choosing the right central lab.
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From screening through neutralizing antibody assays and PK integration — a practical framework for de-risking biologic drug development.
Read MoreIPDA™ HIV-1 IPDA™ SIV IPDA™ SHIV Total HIV-1 DNA qPCR HIV-1 Cell-associated RNA PCR QVOA (Quantitative Viral Outgrowth Assay) HIV-1 Bulk Outgrowth HIV-1 SCA (Single Copy Assay) HIV-1 HIV-1 Viral Load
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