Specialized Bioanalytical Support for Cell and Gene Therapeis

Cell and gene therapies present unique analytical challenges that require scientifically rigorous and fit-for-purpose assay strategies. Sword Bio supports developers of advanced therapies with ligand binding assays designed to characterize immune responses, pharmacodynamic activity, and therapeutic exposure throughout development.

Using ELISA and MSD platforms, we provide bioanalytical solutions from early non-clinical studies through clinical development.

Supporting Advanced Therapeutic Modalities

Our team works with sponsors developing:

  • CAR-T therapies
  • CAR-NK therapies
  • TCR-based therapies
  • Stem cell therapies
  • AAV-based gene therapies
  • Lentiviral gene therapies
  • Genome editing programs
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Bioanalytical Services

Immunogenicity Testing

Evaluate immune responses to therapeutic products and delivery systems through robust ADA and neutralizing antibody assay strategies.

Pharmacokinetic Support

At the protein level, we develop and validate ligand binding assays to quantitate therapeutic exposure by transgene-expressed proteins.

At the molecular level, we can subcontract and oversee qPCR quantitation of transgene in numerous tissues and matrices.

Biomarker Analysis

Measure soluble biomarkers, cytokines, and other pharmacodynamic markers that help demonstrate biological activity and therapeutic effect.

Assay Development and Validation

Customized assay solutions developed and validated to meet study-specific and regulatory requirements.

Why Sponsors Choose Sword Bio

Scientific Continuity

The same scientists who develop and validate your assay lead the project through sample analysis and reporting, ensuring consistency and deep program knowledge.

Scientific Leadership Involvement

Senior scientific leaders remain actively engaged throughout the project lifecycle, providing strategic guidance and technical oversight.

Fast Project Initiation

Projects typically begin within 10–15 business days, helping sponsors maintain aggressive development timelines.

Flexible Study Support

No project minimums. Whether you need a single assay qualification or ongoing clinical sample analysis, we scale to meet your needs.

Commitment to Quality

Quality is the foundation of our organization. From our scientific leadership to our quality systems, we operate in compliance with GLP/GCLP standards to deliver reliable, reproducible bioanalytical data with confidence, on the timeline your program demands.

Partner with Sword Bio

Whether advancing a first-in-human program or supporting late-stage clinical development, Sword Bio provides the expertise and responsiveness needed to generate high-quality bioanalytical data.

Built for Emerging Biotech Companies

We understand the challenges faced by emerging and growing biotech organizations. Our team acts as an extension of your development organization, providing responsive communication, scientific expertise, and reliable execution throughout your program.
Speak with a Sword Bio scientist about your cell or gene therapy program.

Frequently Asked Questions

What types of cell and gene therapies does Sword Bio support?

What bioanalytical services do you provide for cell and gene therapy programs?

How do you support immunogenicity testing for cell and gene therapies?

Can Sword Bio support both non-clinical and clinical studies?

What biomarker assays do you offer?

Which analytical platforms do you use?

How quickly can a project begin?

What makes Sword Bio a strong partner for emerging biotech companies?

Do you have minimum project size requirements?

Can your data support regulatory submissions?

Talk with our scientists about your antibody therapeutic program.