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

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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
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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)
  • GLP soon to be GMP
  • Can be used in GMP environment
  • Regulatory evolutions 
  • 3R compliant ethical solutions that even surpass traditional methods
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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

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
Adventitious viruses detection in crude harvest:
  • 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

Insertion Profiling
Genetic Characterization & Stability
Identification
Purity
Clonality documentation
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Let’s Start Something New

Welcome to PathoQuest!