Biopharma Solution
Adventitious Virus Testing by Genotypic Technology
Ensuring Biopharmaceutical Safety through Advanced Genomic Solutions
What is Adventitious Virus Testing and Why is it Important?
Adventitious viruses pose a critical risk to biomanufacturing, as contamination can occur at various stages—from raw material sourcing to final product packaging. Biological materials such as serum and cell cultures are particularly susceptible, making comprehensive viral detection and characterization essential to ensure patient safety and regulatory compliance.
At Genotypic Technology, we offer cutting-edge genomic solutions for adventitious virus detection. Our approach aligns with Good Manufacturing Practices (GMP) and ensures precise, reliable, and rapid identification of viral contaminants, safeguarding the integrity of biopharmaceutical production.
Traditional vs. Modern Approaches to Virus Detection
Historically, cell-based in vitro assays and in vivo testing have been the standard for detecting viral contamination. While these methods help identify known and unknown viruses through viral amplification, they are often time-consuming and may not be compatible with certain biopharmaceuticals. Additionally, toxicity concerns, lengthy neutralizing antibody development, and limited sensitivity make these methods suboptimal in fast-paced production environments.
Next-Generation Sequencing (NGS): A Superior Approach
Genotypic Technology leverages Next-Generation Sequencing (NGS) for virus detection, offering several advantages over conventional methods:
- Broad-spectrum detection – Identifies both known and novel viral contaminants.
- High sensitivity and specificity – Detects viral genetic material even at low concentrations.
- Rapid turnaround – Reduces delays in batch release and accelerates decision-making.
- Minimal sample volume requirements – Ideal for scenarios with limited biological material.
- Compatibility with diverse sample types – Avoids issues of toxicity affecting in vitro and in vivo assays.
Mitigation Strategies for Viral Contamination
- A robust viral contamination control strategy relies on three pillars.
- Prevention: Isolating processes from contamination sources and conducting rigorous screening of raw materials.
- Removal: Implementing purification techniques like filtration, chromatography, and pH treatments to eliminate contaminants.
- Detection: Continuous monitoring at critical stages, including bulk harvest, to ensure viral safety.
Applications of Genotypic’s NGS-Based Adventitious Virus Testing
- Our NGS-based solutions are tailored for:
- Monoclonal antibodies (mAbs) and recombinant proteins
- Viral vectors for gene therapy
- Cell-based therapies
- Vaccine development
- RNA-based therapeutics
- Cultured meat and alternative proteins
Sample Requirements & Consultation
- To ensure optimal results, we recommend a consultation with our experts to determine the best approach for your specific requirements. General sample requirements include:
- 5ml of harvest material (bioreactor or raw material samples)
- Specific guidelines for viral seed stocks and cell bank samples
- Storage and shipment at -80°C or on dry ice
- Backup sample recommendation for repeat testing if needed
Challenges We Address
- Overcoming sample incompatibility with traditional assays
- Detecting contaminants in low-volume samples
- Meeting stringent clinical timelines
- Supporting non-animal testing approaches
- Troubleshooting batch failures and contamination sources
Why Choose Genotypic Technology?
With decades of expertise in genomic innovations, Genotypic Technology delivers cutting-edge, regulatory-compliant virus detection solutions. Our NGS-based adventitious virus testing ensures the highest safety standards for biopharmaceutical manufacturing, giving you confidence in your product’s integrity and compliance.
For consultations and inquiries, contact us today and secure your manufacturing process with the latest in genomic technology.
HLA Genotyping
Characterizing and screening for novel and emerging cell therapies
At Genotypic, we are committed to making advanced genomics solutions accessible to every scientist and biopharma innovator. Our HLA Genotyping service is designed to meet the evolving needs of cell and gene therapy research, biomanufacturing, and human cell line validation — all with precision, speed, and confidence.
What is HLA Genotyping and why is it important?
Human leukocyte antigen (HLA) genotype testing has traditionally been used for donor-recipient matching in organ transplantation. However, HLA genotyping can also be useful for cellular therapies as it can limit recipient response from the patient. This method can also be used for human cell line characterization and testing across biologic manufacturing as it can identify contaminating cells within the human cell line.
Traditional methods such as long range PCR to identify HLA specific alleles are:
✓ Fast and highly scalable
✕ Can suffer from issues leading to ambiguity of results
Genotypic brings you access to PathoQuest’s proven methodology that eliminates the issues associated with PCR-based NGS sequencing. A hybrid capture step generates the sequencing libraries, providing full coverage for all known and novel HLA alleles across 17 loci of the HLA genes.
What we do
- Allogenic cell therapies
- Gene modified cell therapies, e.g., CAR-T
- Stem cell therapies, including mesenchymal stem cells
- Donor tissue / patient samples
- Cell lines used across biologic manufacturing
- Cell bank identity testing
Why choose Genotypic’s NGS assays for HLA genotyping?
- We help you move faster, go deeper, and detect more — with assays that are:
- Faster in turnaround
- More robust than long-range PCR
- Capable of allele-level resolution
- Offering full coverage across 17 loci, including all exons
- Designed to detect contamination in human cell lines
Challenges we help solve
- PCR failure due to primer mismatch
- Balanced amplification across all HLA alleles
- Base-level resolution, including subpopulation detection
- Detection of contaminating human cells within a human cell line
With Genotypic, cutting-edge HLA genotyping is no longer out of reach. Our Biopharma Solutions are built to simplify complexity — so you can focus on advancing science.
Cell Line Characterization
Biosafety screening and stability testing of manufacturing cells
At Genotypic, we make regulatory-grade biosafety and stability testing accessible to innovators across biopharma and emerging therapeutic spaces. Our NGS-based Cell Line Characterization solutions are designed to meet global regulatory standards — while accelerating timelines and reducing dependency on classical, time-consuming methods.
What is Cell Line Characterization and why is it important?
According to regulatory guidance, all cells used directly as a therapy or within the manufacturing process of a biopharmaceutical must be sufficiently tested to confirm:
Identity testing confirms the cell is as described in the submission
Purity testing ensures that the cell does not contain any adventitious microbial or viral contaminants. It also determines if there is any contamination from other cell lines.
Stability testing generally focuses on the genetic stability of the cell line and ensures that the cells act in the proposed manner across the expected lifetime.
Mammalian cells used for biologic production must be tested for these three categories across a simulated lifetime for the Master and Working Cell Banks (MCB/WCB), as well as the cells at the end of a production run. This ensures that any endogenous or occulted contaminating virus does not emerge unexpectedly. Genetic stability testing across this lifetime also provides assurance that the quality and yield of the biopharmaceutical product can be maintained by the manufacturer.
Classical cell line characterization packages use a range of in vitro and in vivo cell assays and other molecular assays for contamination detection. Cell line stability testing can use a mix of Sanger sequencing, PCR, and cytological methods such as FISH. A full biopharmaceutical characterization package can typically take anywhere between 3 to 6 months.
NGS-based approaches to cell line characterization developed and validated by PathoQuest offer several advantages, especially where traditional testing proves challenging. NGS can provide results much faster and is a viable alternative if there is a compatibility issue with the traditional approach (e.g., a lack of neutralizing antibody or available sample volume). NGS also offers a higher level of information, particularly in cell sequencing to characterize genetic modifications or insertions of sequences into the cell line.
Finally, using an NGS testing strategy can provide a rapid way to screen and identify favorable candidates during the cell line selection process.
What we do
- mAbs and recombinant protein biologics
- Viral vectors
- Cell therapies
- Vaccines
- RNA-based therapeutics
- Cultured meat
Challenges we help solve
- Incompatibility of sample with traditional assays
- Very low sample volumes
- Tight clinical timelines
- Meeting corporate objectives for removing animal use
- Discriminating infectious virus from non-replicating carryover
With Genotypic’s NGS-powered cell line characterization, you gain faster, richer, and regulatory-aligned insights — without compromising on quality or timelines. We bring biosafety within reach.
Identity Confirmation
Genetic characterization of viral and plasmid products for release
At Genotypic, we simplify complex regulatory requirements by making advanced nucleic acid identity testing accessible and efficient. Our NGS-based Identity Confirmation service is purpose-built for the biopharma ecosystem — offering deep, accurate characterization of viral vectors, plasmids, and other critical raw materials to support reliable product release.
What is Identity Confirmation and why is it important?
Identity testing is a critical component to release vector products, including viral and non-viral cell and gene therapies, as well as vaccine and oncolytic applications. Determination of the nucleic acid sequence of the vector and gene of interest is a regulatory requirement, with full nucleic acid sequence provision for vectors under 40 kb. Therefore, direct sequencing is a standard and well-accepted approach.
Sanger sequencing has traditionally been employed for nucleic acid testing and is well accepted by regulators. However, an NGS approach provides several advantages over Sanger sequencing:
Identify ultra-rare genetic variants <5% (Sanger variant detection limit ~20%)
More cost- and time-efficient than sequential Sanger runs
Full coverage is often challenging with Sanger sequencing
As there is a regulatory expectation for appropriate characterization of critical raw materials, an aligned nucleic acid analysis strategy should also be employed for any plasmid input materials. This mitigates the risk that non-clonal variation within the manufacturing plasmids will affect the quality of the final product.
NGS screening offers several advantages, including the ability to detect ultra-rare genetic variants and providing more comprehensive coverage than traditional methods. This makes NGS a superior choice for nucleic acid testing in the context of ensuring the integrity and quality of vector products, plasmids, and other critical raw materials.
By leveraging the advantages of NGS over Sanger sequencing, manufacturers can ensure a higher standard of nucleic acid analysis, ultimately contributing to the reliability and efficacy of the final biopharmaceutical products.
What we do
- Plasmids
- Vaccines (Viral and RNA)
- Gene Therapy Vectors
- Oncolytic Virus
- Bacteria
Challenges we help solve
- AAV ITR and lentivirus LTR sequencing by Sanger
- Difficult-to-sequence promoter regions within vector
- Reducing number of Sanger sequencing runs
- Alignment of methods between plasmid and vector release
Genotypic enables you to meet stringent regulatory expectations with clarity and confidence. With our advanced Identity Confirmation solutions, your biopharma innovations are one step closer to reliable release.
