Quantitation of residual host cell DNA levels using digital PCR technology to determine the host cell impurities in target samples (in-process, final product, etc.), supporting the risk assessment and regulatory compliance of biological products.
Contamination of residual host cell DNA in biological products poses the potential risks to the patients. To ensure the safety and regulatory compliance of biological products, BaseClear provides the phase-appropriate analytical testing service to monitor and quantify the residual host DNA in a broad range of samples containing different matrix compositions derived from several producer cell species (e.g. HEK, E.coli, CHO, Vero, Sf9). We also offer expert consultation and custom project design to ensure high-quality data delivery and optimal solutions tailored to the client’s specific requirement.
Residual host cell DNA testing in biological products from biopharmaceutical/biotechnology sectors for:
Residual host cell DNA in the biological samples is detected and quantitated using QIAcuity digital PCR technology, which relies on the absolute quantitation of the target DNA concentration using sample partitioning method in a microfluidic nanoplate system. Due to the endpoint quantitation without the need of standard curves, the assay is less susceptible to PCR inhibitors and amplification biases, increasing assay precision and providing the advantage over the quantitative PCR (qPCR) assay.
We offer an extraction-free residual host cell DNA quantitation directly in the target samples, circumventing the need of additional custom sample extraction optimization with different sample compositions and providing more simplified analytical workflow.
Our residual host cell DNA testing platform was developed and pre-validated in the common representative biological samples according to ICH Q2 guideline. This is to demonstrate that the method is fit-for-purpose to measure the residual host cell DNA in these typical biological matrixes, providing an early insight into the overall fit-for-purpose assay performance to our clients.
Deliverables:
Contact us & Free consultation with BaseClear expert team for specific project requirement
Project-specific quotation according to service scope:
Fit-for-purpose evaluation of method performance in client’s samples containing specific matrix composition:
Protocol drafting by BaseClear team
Protocol reviewing by clients
Protocol revision by BaseClear team with client’s input
Protocol approval by BaseCear team and clients
Sample submission by clients
Study execution, analysis, and internal data quality review by BaseClear team
Tailored study/testing report drafting by BaseClear and report reviewing by clients
Study report revision by BaseClear with client’s input
Final study report and data package provided to clients.
Confirmation of fit-for-purpose method performance status, supporting routine testing of client’s samples.
(Optional) Routine testing of the client’s samples:
Testing protocol drafting by BaseClear and protocol reviewing by clients.
Testing protocol revision by BaseClear with client’s input.
Execution of testing protocol by BaseClear.
Testing report drafting by BaseClear and report reviewing by clients.
Testing report revision by BaseClear with client’s input.
Final testing report and data package provided to clients.
Genomics and sequencing projects completed
Years of sequencing and genomics expertise
Validated molecular analysis workflows
Cell culture samples analysed
Cell line species identification determines the biological species from which cultured cells originate using genetic analysis. This verification ensures that cell lines used in research or production correspond to the expected organism and are not contaminated by cells from another species.
Species identification is important because misidentified cell lines can compromise experimental reproducibility, research credibility, and regulatory documentation. Confirming species origin ensures that cell cultures accurately represent the intended biological model.
The mitochondrial cytochrome c oxidase subunit I (COI) gene is widely used for DNA barcoding because it shows strong sequence variation between species while remaining relatively conserved within species. This makes it a reliable genetic marker for species-level identification.
COI sequencing can detect cross-species contamination by revealing whether the genetic sequence corresponds to a different species than expected. This helps identify cases where cell cultures may have been contaminated with cells from another organism.
STR profiling is typically used to authenticate human cell lines, whereas COI sequencing determines the species origin of animal cell lines. Both methods are complementary and may be used together in comprehensive cell line quality control programs.
Species identification is recommended when establishing cell banks, acquiring new cell lines, or performing routine quality control of cell culture systems. Early verification helps prevent costly downstream issues caused by misidentified cell lines.
Detect mycoplasma contamination in cell cultures using sensitive molecular detection methods.
High-accuracy DNA sequencing for PCR products, plasmids, and targeted genetic regions.
Quantify the residual host cell DNA in your samples using digital PCR technology.
Speak with our experts to discuss your cell line identification project. We will help you determine the appropriate analysis approach and provide reliable sequencing results to support your research and quality control workflows.
