PAD for Cell & Gene Therapy

Why PAD Services for  Cell & Gene Therapy Development?

PAD services are the only way to fully leverage the Tapestri platform to consolidate assays, produce multi-attribute datasets, and glean powerful single-cell insights to advance your analytical characterization program. Our PAD team will work closely with you to develop, run, validate, and transfer these powerful assays to your site, CRO, or CDMO of choice to accelerate your release of market-ready cell and gene therapeutics.

Expedite Your Therapy Development Pipeline

“For the first time, we are able to measure multiple therapeutic parameters simultaneously, such as vector copy number, transduction efficiency, gene editing outcomes, and genomic stability. And we can do it in a matter of days, minimizing sample usage and accelerating data insights that may provide critical indicators of safety and potency. The Tapestri® Platform’s ability to provide these analytics in a consistent, high-resolution manner at the single-cell level, while eliminating laborious steps, addresses the industry’s top concerns.”

Chris Mason , Professor of Cell & Gene Therapy, University College London

PAD Services Support & Process

Fully Customized Single-Cell Analysis Integration

PAD services develop custom assays based on client need and drug development phase. We recognize and can aid in dealing with the heightened challenge of assessing the safety and efficacy of CGT products compared to conventional therapies due to the many potential variations between genetically altered cells.

Once a custom assay is developed and validated, our PAD services team will provide the support and installation required to get the assay up and running.

PHASE 1: FIT FOR PURPOSE ASSESSMENT

Sample: Control cell lines
Includes client’s product specific panel

Initial analysis methods testing is conducted on a preliminary set of experiments to establish Tapestri for intended use

Phase 2: Preliminary assay validation

Sample: Experimental cell lines
Intent is to confirm assay specificity, sensitivity, and linearity

Possibility to expand across multiple drug products or lots

Phase 3: Transfer GMP ready assay to Client or CDMO

Tapestri instrument installation, premium training
Operational and performance qualifications (IOQ/PQ)
Lot-controlled customized product bundle for transfer and assay qualification

Deliverables:

Final transfer report
Wet lab and sequencing procedures
Cloud-hosted bioinformatics pipeline and user guide
Formal documentation

Driving Success Through PAD Partnership

Drive Therapeutic  Success With Streamlined Analytical Characterization

Why PAD Services for  Cell & Gene Therapy Development?

Expedite Your Therapy Development Pipeline

PAD Services Support & Process

Fully Customized Single-Cell Analysis Integration

Deliverables:

Our team has successfully supported design transfer to drug sponsors, CROs, and CDMOs, fully integrating the power of single-cell assays during drug manufacturing and lot release.

Driving Success Through PAD Partnership

Get Started

Drive Therapeutic Success With Streamlined Analytical Characterization

Why PAD Services for Cell & Gene Therapy Development?

Expedite Your Therapy Development Pipeline

PAD Services Support & Process

Fully Customized Single-Cell Analysis Integration

Deliverables:

Our team has successfully supported design transfer to drug sponsors, CROs, and CDMOs, fully integrating the power of single-cell assays during drug manufacturing and lot release.

Driving Success Through PAD Partnership

Get Started

Drive Therapeutic  Success With Streamlined Analytical Characterization

Why PAD Services for  Cell & Gene Therapy Development?