Quality Control of Biologics
Industrial applications
From vaccines to cell & gene therapies, and monoclonal antibodies, ensuring the safety of the products is the major concern when it comes to the development of biologics.
Our understanding of the science behind biological technologies allows us to bring you the novel technologies to remain competitive by decreasing facility space cost while keeping high expertise with state-of-the-art technology.
Our Span of Action
ATMPs
We can align with your ATMPs’ specific goals, speak the same language, and help you be nimbler to provide the answer to your daily genomic challenges.
Why PathoQuest?
- More accurate and sensitive than classical assays NGS is able to differentiate between carryover and true contamination
- Allows releasing with high confidence the drug product,
- Regulatory agencies have accepted NGS data over qPCR data
- Fast turnaround times (2-4 weeks)
- Cost-effective and comprehensive viral safety and genetic characterization
- Easy access to the experts team
Vaccines
Quality control is a cornerstone of vaccine development. PathoQuest provides a panel of high-quality assays that can reduce the risk of failure during clinical trials and the licensure process.
Why PathoQuest?
- More accurate and sensitive than classical assays
- One-stop-shop with viral safety and genetic characterization
- Enables release with high confidence in the product
- Regulatory agencies have accepted NGS data over qPCR data
- Fast turnaround times (2-4 weeks)
- GMP environment
- Regulatory evolutions
- 3R compliant ethical solutions that even surpass traditional methods
Other Biologics
Controlling the quality of raw materials used in cell culture-based biotech manufacturing processes is a particularly challenging and critical task. PathoQuest’s transcriptomic NGS approach enables the detection of only replicative viruses and reduces the risk of false-positive.
Why PathoQuest?
- Proprietary metabolic labeling method
- Added risk mitigation capabilities in a one-shot assay
- Possibility to detect difficult agents such as Mycoplasma or dsRNA virus, it can also identify a subset of vRNAs synthesized in a short window of time
- Possibility to test on serum
- Allows a high confidence release of your product
- Differentiate carryover from living agent
- 3R compliant ethical solutions
NGS is a key tool to assess the compliance of biologics in a safer, faster, and more ethical way.
Read Sridhar Pennathur, NOVAVAX INC VP, Analytical Development view on a game-changing use of NGS for the vaccine industry where safety is crucial and where, as the last 2 years have demonstrated, speed is the differentiator.
Read the full article here
Transgene is a French biotech developing virus-based immunotherapies. There manufacturing processes deal with breakthrough therapeutic vaccines highly awaited by patients.
It is critical to ensure compliance in a fast and safe way, they chose PathoQuest because NGS is the most suitable and rapid approach to assess the raw materials and biological products for viral contaminants.
Our solutions for your industry
Viral Safety
Transcriptomic approach : Cell safety
Comprehensive detection of living contaminant in cell banks:
- Focus on pathogen messengers
- Detect only living adventitious agents
- Has demonstrated the absence of replication in cell bank with PCR positive results
Virome approach: Virus safety
- Focus on intact viral particles
- Capacity to detect viruses spiked at 103 gc/mL into concentrated and viscous crude
- Has been accepted for product release in clinical trials
Metabolic labeling approach : Raw materials safety
A new method to be used as a read-out of raw material testing using your own production cells for the securitization of your processes:
- Focus on newly synthesized messengers
- Clear Score Threshold for positive/negative
- Has demonstrated the detection of replicating viruses and mycoplasma in difficult samples such as blood-derived materials
Genetic Stability & Characterization Whole Genome Sequencing
Let’s Start Something New
Welcome to PathoQuest!