Biotherapeutics are transforming healthcare for over 350 million patients globally, tackling everything from cancer and diabetes to rare diseases.
Human embryonic kidney (HEK) 293 cells play a key role in the manufacturing of many of these life-changing products. However, they are not without their challenges.
In this episode of The Top Line, sponsored by Bio Rad Laboratories, we’re joined by Dipika Gurnani, Global Product Manager from Digital Biology Group to explore the importance of quantifying HEK 293 DNA in biotherapeutics.
Patient safety is at the forefront of discussions, with Gurnani outlining the potential health risks that can arise should residual DNA integrate into a patient's genome, leading to harmful effects such as oncogenesis or other genetic abnormalities.
Attentions then turn to the guidelines that the FDA, EMA and other regulatory bodies have in place to address these risks, with Gurnani explaining the role of accurate quantification in ensuring compliance that can in turn drive product approval and market entry.
Unfortunately, there are challenges with traditional methods of quantification, such as qPCR.
“If you're using qPCR, it becomes necessary for you to undertake DNA testing extraction, a process that consumes a lot of time,” Gurnani reveals, who also points to the need for a reference point, the difficulties in maintaining a standard curve to achieve this, and other issues such as process inhibitors.
The key lies in managing and mitigating false positives, something that can be achieved using an innovative new way of HEK 293 quantification: Bio-Rad’s Vericheck ddPCR HEK293 Residual DNA Quantification Kit.
“This design minimizes cross reactivity with non-target DNA, ensuring that the assay is highly specific to just HEK293 target DNA,” Gurnani adds.
To learn more about the challenges and subsequent innovation in the critical field of biotherapeutics and HEK 293 DNA quantification, tune into the full episode.