BaseClear’s Viral Contamination Panel for Bovine and Porcine Cells (according to 9 CFR 113.47) uses digital PCR technology to provide highly sensitive, accurate, and regulatory-compliant detection of viral contamination, offering a rapid and robust alternative to traditional antibody-based methods for cell line validation.
BaseClear’s Viral Contamination Panel for Bovine and Porcine Cells (9 CFR 113.47) is a high-performance diagnostic service designed to detect viral contamination in bovine and porcine cell lines used for vaccine production and other biopharmaceutical applications. This panels tests viral contamination of Bovine or Porcine cells according to the 9 CFR 113.47 regulations, which are critical for ensuring the safety and quality of animal-origin cell lines.
This service is ideal for pharmaceutical companies, biotechnology firms, and research institutions involved in vaccine development, bioprocessing, and cell-based therapeutics. Specifically, it is intended for clients working with bovine and porcine cells that are used in the production of vaccines and biologics. It is also highly relevant for quality control laboratories and regulatory bodies that require precise validation of cell line safety and integrity. By using this service, clients can ensure their cell cultures are free from contamination, helping to avoid costly delays in production, product recalls, or non-compliance with regulatory requirements.
BaseClear’s Food Safety Digital PCR Panel utilizes the Qiagen QIAcuity One digital PCR platform, a state-of-the-art technology known for its superior sensitivity, accuracy, and reliability in detecting low-abundance DNA targets. The QIAcuity One platform partitions the sample into thousands of individual reactions, enabling precise quantification of pathogen DNA without the need for reference standards or calibration curves. This approach ensures highly reproducible results, even in complex food matrices or samples with low pathogen concentrations.
When using BaseClear’s Viral Contamination Digital PCR Panel for Bovine and Porcine Cells, clients receive a comprehensive report with detailed insights into the number of DNA or RNA copies detected for each target viral contaminant. The report clearly outlines the presence or absence of each virus, along with the exact copy number of viral DNA or RNA in the sample.
We assess whether the test strain can be cultivated under standard MIC conditions. Where necessary, conditions are adapted to ensure valid and reproducible susceptibility testing.
We define the antimicrobial panel and testing strategy based on regulatory requirements and strain type
Your strain is tested using standardized broth microdilution assays under controlled laboratory conditions
Quality control strains and acceptance criteria are applied to ensure data reliability and compliance.
Results are interpreted in line with EFSA guidance, including assessment of intrinsic versus acquired resistance.
MIC testing performed according to CLSI standards
Integrated wet-lab and bioinformatics workflows
Expertise in distinguishing intrinsic versus acquired resistance
Clear, dossier-ready reporting to support regulatory submissions
Digital PCR offers superior sensitivity and quantification compared to traditional PCR by partitioning the sample into thousands of individual reactions, allowing for absolute quantification of viral DNA or RNA. This enables the detection of very low levels of contamination that may be missed by traditional PCR methods, which are typically less sensitive and often rely on relative quantification.
As specified in 9 CFR 113, the following viral contaminants are detected.
Bovine: Bovine virus diarrhea virus, Reovirus, Rabies virus, Bluetongue virus, Bovine adenoviruses, Bovine parvovirus, Bovine respiratory syncytial virus
Porcine: Bovine virus diarrhea virus, Reovirus, Rabies virus, Porcine adenovirus, Porcine parvovirus, transmissible gastroenteritis virus, Porcine hemagglutinating encephalitis virus.
This panel is specifically designed to test bovine and porcine cell lines, including primary cells, cell cultures, and stocks used in vaccine production or other biopharmaceutical applications. It can also be applied to cell harvests and production batches to ensure the absence of viral contamination before further processing.
Standard delivery time for this service is 5 business days after receiving the sample(s). Premium delivery can be requested, and is 3 business days after receiving the sample(s).
As specified in 9 CFR 113, caprine, and ovine cells shall be tested similar to Bovine cells, and can therefore also be tested.
Genomic analysis to identify antimicrobial resistance genes and support
Evaluation of biologically active metabolites to assess functional and toxicological risks
Demonstration of absence of viable cells and recombinant DNA in final products for regulatory compliance
Integration of MIC, genomic, and safety data into a submission-ready regulatory dossier
Get expert guidance on MIC testing, interpretation, and regulatory strategy to avoid delays in your submission. Start with a free consultation tailored to your project.
