AAPS ASGCT 2026 I BioAgilytix

As cell and gene therapy programs advance, the analytical strategy behind them becomes increasingly critical. From vector characterization to clinical bioanalysis, decisions made early can directly impact timelines, data quality, and regulatory success.

That’s where the right partner makes a difference.

BioAgilytix works alongside teams developing AAV, viral vectors, cell therapies, and genetic medicines to build analytical strategies aligned with both the complexity of the modality and the stage of development.

From early method development through clinical testing and CMC support, our focus is simple: generate data you can move forward with confidence.

Cell and gene therapies introduce unique analytical challenges, from immune response and biodistribution to potency and product characterization.

BioAgilytix brings together bioanalytical and CMC analytical expertise under one global framework, helping reduce handoffs and maintain consistency across development stages.

Our team’s support:

AAV and viral vector bioanalysis (PK, biodistribution, immunogenicity)
Cell therapy support, including ligand binding and cell-based assays
Integrated LC/MS and ligand binding assay strategies
Potency and product characterization strategies aligned with regulatory expectations
Method development, validation, and transfer
QC release and stability testing

With laboratories across the United States, Europe, and Australia, BioAgilytix delivers scalable capacity with harmonized processes and consistent global quality.

TASGCT 2026 Annual Meeting is the leading global event focused on the development of cell and gene therapies, bringing together scientists, clinicians, and industry leaders advancing genetic medicine.

The conference spans discovery through clinical development and commercialization, with a strong focus on emerging modalities, regulatory expectations, and translational science.

BioAgilytix supports these programs with integrated bioanalytical, and CMC analytical services designed to generate reliable, decision-ready data, reduce complexity across development stages, and support evolving regulatory expectations.

What types of programs does BioAgilytix typically support?

We support many ATMPs, such as AAV, viral vectors, LNP, mRNA and cell therapy programs across preclinical, clinical, and commercialization stages.

Can you support both bioanalytical and CMC analytical needs?

Yes. That’s where many clients see the most value. We help bridge these areas to reduce handoffs and maintain consistency across your program.

When is the right time to engage with BioAgilytix?

Earlier than most teams expect. Early alignment on analytical strategy can help avoid delays, rework, and regulatory risk later.

What challenges do you typically help solve?

We often support programs navigating:
• Immunogenicity and ADA challenges
• Potency assay development
• Biodistribution strategies
• Method transfer and validation.

Do you support global programs?

Yes. Our global lab network operates under harmonized processes, enabling consistent data and scalable support across regions.

2026 ASGCT Annual Meeting

BioAgilytix is Supporting the Science Behind Cell & Gene Therapy

When Modality Complexity Increases, Your Analytical Strategy Has to Keep Up

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