Biotherapeutics must go through rigorous purification processes during their development and manufacturing. However, low levels of residual or plasmid DNA can often remain after purification, affecting the safety and efficacy of final products.
Although many labs opt for in-house methods to screen for residual DNA, these can be costly, time-consuming and require specialist expertise.
Discover a fully integrated commercial real-time qPCR solution that can improve efficiency, reduce workloads and ensure regulatory compliance in your lab today.
Download this application focus to explore:
• How to produce reliable, reproducible results for in-process and lot-release studies
• An optimized, rapid sample preparation protocol
• An established and trusted system adopted for use by major biopharma companies
Application Focus
Quantifying Residual DNA in a
Biotherapeutic Manufacturing Workflow
Author
Summary
Ilaria Scarfone
Residual host cell and plasmid DNA can survive purification methods in
biotherapeutic development and manufacture, affecting safety and efficacy of the
final product. Thermo Fisher Scientific’s fully integrated commercial kits for residual
DNA analysis deliver rapid, reliable and highly consistent solutions for quality control
(QC) and lot release.
The challenge of residual DNA
Biotherapeutics are manufactured by modifying living cells in order to create therapeutic
products, such as gene therapies and vaccines. During manufacture, low levels of cellular
DNA from the host cell, or plasmid DNA derived from the manufacturing reagents, can survive
the purification process. This is known as residual DNA, and transference to the patient in
biotherapeutic products may lead to an increased risk of oncogenicity and immunogenicity.
In light of these safety concerns, regulatory guidance for products produced in cell culture
specifies that residual DNA content in the final product must be as low as possible, as
quantified by a highly sensitive, reliable testing method.
While many laboratories opt to develop in-house protocols for residual DNA analytical
methods, this can result in multiple challenges and a considerable investment of time,
resources and specialized expertise. Controls and standards must be highly robust, ensuring
material stability and linearity of the standards. In addition, all standard operating procedures
(SOPs) must be validated under the ICH Q2 (R1) guidance for analytical procedures.
