Count what counts

The characterization bar in Cell & Gene Therapy workflows is rising. Countable PCR is already there.

Your current CGT workflow is stitching together incomplete answers.

If you’re troubleshooting titer-to-potency discrepancies, struggling to characterize impurity integrity, or trying to build a defensible genome integrity story for your IND filing, you already know the problem.

Countable PCR delivers single-molecule resolution for genome integrity assessment — precisely distinguish full-length from partial genomes with the reproducibility your release workflows demand. Measure multiple CQAs simultaneously and establish robust batch comparability, all from one assay.  

Be ahead of the characterization curve. 

With Countable PCR:

True single-molecule counting

Delivers clean, highly precise signal and absolute quantification for highly reproducible results

Combine multiple CQAs in one

Combine multiple CGT critical quality attributes to simplify workflows and reduce cost - such as titer, genome integrity, plasmid-derived impurities or residual host DNA

GMP-friendly

Designed for regulated environments with software built for auditability and compliance

Accelerate assay deployment

Leverage ready-to-use Pre-designed Assays for CGT workflows or use Assay Services for fast generation of proof-of-concept data

Count What Counts Grant Program

Stop guessing. Start knowing.

Submit your proposal for a chance to win a FREE CGT Profiling Service project from Countable Labs.

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White Paper: Cell & Gene Therapy

Analytical characterization is one of the biggest bottlenecks in CGT development. This whitepaper cuts through the complexity, comparing the platforms your team is already using—and showing where single-molecule counting changes the equation.

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CGT Profiling Services

De-risk your next CGT milestone

Understand exactly what is in your vector or cell lines quickly. Our CGT profiling service delivers rapid proof-of-concept insights using single-molecule linkage PCR, so you can make confident decisions at your next critical milestone. 

Built for rapid POC studies:

  • Genome integrity and titer
  • Residual DNA & full-length, plasmid-derived impurities
  • Vector copy number (VCN)
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Upcoming Webinar: Assessing DNA impurity integrity in rAAV gene therapy manufacturing

The countdown is complete

Topics to be covered:

  • Importance of DNA impurity integrity in rAAV safety assessment
  • Limitations of conventional PCR in distinguishing DNA fragment types
  • Principles of single-molecule linkage analysis for impurity characterization
  • Integration of integrity-based measurements into quality control workflows
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David Dobnik, PhD
Assistant Professor
National Institute of Biology (NIB)

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Emily Blair, PhD
Senior Project Manager
Countable Labs

Explore the science

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White Paper

Advances in genomics-based analytical characterization for cell and gene therapy

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App Note

Rapid, quantitative viral genome integrity measurements using multiplex Countable PCR assays

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App Note

Accurate, one-step lentiviral titration with the RNA Module for Countable PCR

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I'm ready to talk to an expert about how Countable PCR can help me with my CGT workflow