Bio-Rad Expands DNA Testing Kits for Cell and Gene Therapy Manufacturers

Bio-Rad Laboratories has added five new kits to its Vericheck ddPCR lineup, built to run on its QX700 digital PCR system. While not the flashiest announcement, it does address a key problem that those who work in cell and gene therapy manufacturing will recognise. That problem is proving a batch is clean and correctly assembled before it's cleared for use.

The new kits cover Mycoplasma Detection, Empty-Full Capsid analysis, Replication Competent Lentivirus testing, and residual host cell DNA quantification for both CHO cells and E. coli. All five run on the QX700 System, the platform Bio-Rad launched with seven-colour multiplexing and a claimed capacity of up to 384 reactions in roughly two and a half hours.

Cell and gene therapy manufacturing doesn't leave much margin for error as batches are frequently small, sometimes made for a single patient, and rarely cheap to produce. There's no option to shrug off a failed QC test and just run another batch next week. Checks like confirming a viral capsid is actually carrying its therapeutic cargo, rather than sitting empty, or ruling out that a lentiviral vector has picked up the ability to replicate, are what regulators want to see before a product moves forward.

Droplet digital PCR has become the method of choice for this kind of work. Instead of relying on a standard curve, as conventional qPCR does, it splits a sample into thousands of tiny droplets and simply counts how many come back positive. The result is generally better sensitivity to low-level contamination and residual DNA, which counts for a lot when even a trace amount can hold up a release decision.

Stephen Kulisch, Vice President of Marketing for Bio-Rad's Digital Biology Group, said the expansion "offers validated workflows with unmatched precision and sensitivity, combined with the power of the QX700 platform, enabling scalable, streamlined workflows and faster time to actionable results." He added that the move reflects the company's "commitment to support development of safer and more efficient advanced therapeutic development and manufacturing."

The word "unmatched" should probably be taken with a pinch of salt, as you would with any line from a marketing executive. Thermo Fisher, Qiagen and others all compete in this space, and it'll be down to independent labs, not press releases, to say how the Vericheck kits actually stack up to competitors. But it is hard to argue with the trend behind the launch, which is that as more cell and gene therapies work their way through clinical development, developers need QC assays that are already validated rather than something they have to build and optimise themselves since this alone can save all-important time on a development timeline.