Cell Therapy Manufacturing and Quality Control

Count on Bio-Rad for Assays to Help Ensure Manufacturing Quality and Safety

Efficiently ensure the safety of your cell therapy manufacturing process, whether you are evaluating transgene copy number or verifying the absence of microbial pathogens.

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Leveraging the Speed and Sensitivity of ddPCR™ Technology for Cell Therapy Manufacturing

When it comes to quality control (QC) lot release assays, you need easy-to-implement, high-throughput assays that you can have the utmost confidence in. For detecting impurities such as microbial pathogens, you also need sensitivity.

With Droplet Digital™ PCR (ddPCR™) technology, you can have it all — easy-to-use plate-based instruments that deliver quantitative accuracy, sensitivity, and reproducibility.

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ddPCR instruments and assays from Bio-Rad are robust enough to meet the needs of QC environments. Learn More

Ensure Viral Vector Purity Before Treating Cells

Detect HEK293 Residual DNA

With many viral vectors manufactured in HEK293 cells, accurate and precise quantification of residual HEK293 DNA is essential for producing a safe transgene delivery vector. However, the standard methods used for such quantification, like qPCR, face challenges due to lack of specificity and reproducibility. The Vericheck ddPCR HEK293 Residual DNA Quantification Kit, with a novel 5-plex ddPCR assay, has been designed to quantify residual HEK293 DNA in biotherapeutics with high specificity and reproducibility, without the need for reference curves.

  • Achieve high sensitivity and specificity
  • Move quickly with an easy, extraction-free protocol
  • Efficiently meet regulatory requirements

Learn More and Order the Vericheck ddPCR HEK293 Residual DNA Quantification Kit »

Bio-Rad instruments and software for ddPCR technology meet Good Manufacturing Practice (GMP) regulations and QC environments and comply with U.S. FDA 21 CFR Part 11 regulations.

Our compliance with International Organization for Standardization (ISO) extends beyond ISO 9001 to ISO 13485 and includes stringent documentation requirements and product-specific demands.

Size HEK293 Residual DNA

Verify that any HEK293 residual DNA in your transgene delivery vectors is below the FDA-recommended size of 200 base pairs with the Vericheck ddPCR HEK293 Sizing Kit. This kit is the first HEK293-specific ddPCR based residual DNA sizing solution that has been designed and validated to meet regulatory guidance requirements and is capable of measuring HEK293 size without the use of reference curves.

  • Achieve high sensitivity and specificity
  • Move quickly with an easy, extraction-free protocol
  • Efficiently meet regulatory requirements

Learn More and Order the Vericheck ddPCR HEK293 Residual DNA Size Kit »

Efficiently Quantify Transgene Copy Number

Turn the ddPCR assay you developed for quantifying transgene copy number into a robust cell therapy manufacturing QC lot-release tool to ensure quality and standardized potency.

With ddPCR technology, quantification does not depend on amplification efficiency but instead uses endpoint PCR to deliver absolute measurement. The process starts by isolating individual transgenes from your sample into discrete, volumetrically defined droplet partitions. Then, inside each partition, the nucleic acid is amplified if the transgene is present. Quantification is determined by calculating the ratio of transgene-positive partitions to transgene-negative partitions.

Transgene measurement with ddPCR technology is precise and accurate, and with our family of ddPCR instruments, straightforward to learn and implement.

Learn More about Using ddPCR Technology for Cell Therapy »

Featured Publications

Test for Mycoplasma Contamination

When choosing an appropriate Mycoplasma detection method, researchers need to consider sensitivity and turnaround time. Traditional culture-based detection tests, for instance, can take up to 28 days to deliver results and often produce false positives.

ddPCR detection, on the other hand, provides high sensitivity with a quantitative readout that reports both in genome copies (GC) per reaction and colony-forming units (CFU) in less than one day. The ddPCR technology also demonstrates high reproducibility across operators, instruments, lots, and days.

Perform quality control analysis to detect Mycoplasma contamination with our probe based Vericheck ddPCR Mycoplasma Detection Kit. The high sensitivity and specificity of this kit allow for precise measurements of 112 mycoplasma species using ddPCR.

Learn More and Order the Vericheck ddPCR Mycoplasma Detection Kit »



Application of Droplet Digital PCR for the Detection of Vector Copy Number in Clinical CAR/TCR T Cell Products
Lu A, et al. J Transl Med. 2020; 18: 191.

Digital-Droplet PCR for Quantification of CD19-Directed CAR T-Cells
Mika T, et al., Front Mol Biosci. 2020; 7: 84.


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