Quality Control of Biologics

YOUR GENOMIC EXPERT
FOR BIOLOGICS TESTING

Robust and efficient quality control testing is critical for the development of biologics to reduce time to market and improve patient outcomes.​ Developers and producers need QC testing solutions which help de-risk their product development pipelines by preventing contamination with adventitious agents and cell lines misidentification

WHAT WE DO

PathoQuest offers advanced Next Generation Sequencing (NGS) solutions that supplement or replace traditional testing methods and support the strategic decision-making process for the release of your product. This innovative approach enables a robust and unambiguous level of testing and faster turnaround time in either an R&D, GLP, or a GMP environment.

Adventitious agents

Adventitious agents such as viruses and mycoplasmas can contaminate biopharmaceutical production systems and remain undetected with consequential risks to the final product.

NGS testing is a technique that does not require targeted primers to identify contamination. Instead, it is able to concurrently scan millions of RNA/DNA sequences. After sequences of interest are identified, bioinformatics tools are used to scan through these sequences and determine matches to known agents, with the added ability to identify new, previously unknown pathogens.

Genetic Characterization

NGS permits parallel sequencing of millions of DNA fragments and is now recognized as a powerful and reliable tool for full genome sequencing.

The combination of PathoQuest’s expertise in microbiology and virology combined with state-of-the-art NGS sequencing platforms makes us a unique solution provider for your studies on cell lines and virus stocks when evaluating identity and/or purity (monoclonality).

 

All you need is 2 minutes to learn how to create additional value for your biologics QC testing program >>

PathoQuest is the first company in France to have a facility that has received GLP certificate of conformity following a successful inspection by the French National Agency for Medicine and Health Products Safety (ANSM).

WHY
WE ARE DIFFERENT

Quality Control of Biologics >>

NGS testing for a faster time to release

NGS metagenomic approaches enable the testing of all biological media and other components that are used in the development of biologics from the R&D stage to the batch release of marketed products, including investigations in the case of a contamination. By including raw material testing in your viral safety package, you can lower the risk of finding a contaminant at a later stage in your production processes.

Our upfront sample preparation can be adapted to many matrices including cell banks, virus stocks, raw materials and product intermediates. This avoids the development of specific neutralizing antibodies (no antiserum from animal origin) with three options for the delivery of results:

  • regular (4 to 8 weeks depending on the service chosen)
  • fast track
  • emergency (2 weeks)

All you need is 2 min to create additional value for your biologics QC testing program >>

WHY WE ARE DIFFERENT

Quality Control of Biologics >>

NGS testing for a faster time to release

NGS metagenomic approaches enable the testing of all biological media and other components that are used in the development of biologics from the R&D stage to the batch release of marketed products, including investigations in the case of a contamination. By including raw material testing in your viral safety package, you can lower the risk of finding a contaminant at a later stage in your production processes.

Our upfront sample preparation can be adapted to many matrices including cell banks, virus stocks, raw materials and product intermediates. This avoids the development of specific neutralizing antibodies (no antiserum from animal origin) with three options for the delivery of results:

  • regular (4 to 8 weeks depending on the service chosen)
  • fast track
  • emergency (2 weeks)

All you need is 2 min to create additional value for your biologics QC testing program >>

WHY WE ARE DIFFERENT

Quality Control of Biologics >>

NGS testing for a faster time to release

NGS metagenomic approaches enable the testing of all biological media and other components that are used in the development of biologics from the R&D stage to the batch release of marketed products, including investigations in the case of a contamination. By including raw material testing in your viral safety package, you can lower the risk of finding a contaminant at a later stage in your production processes.

Our upfront sample preparation can be adapted to many matrices including cell banks, virus stocks, raw materials and product intermediates. This avoids the development of specific neutralizing antibodies (no antiserum from animal origin) with three options for the delivery of results:

  • regular (4 to 8 weeks depending on the service chosen)
  • fast track
  • emergency (2 weeks)

WHY USE NGS FOR THE QUALITY CONTROL OF BIOLOGICS?

Comprehensive & Integrated Services for QC testing of your Biologics in GLP environment:

— Cell therapy
— Cell banks & Control cells
— Virus seeds or bulks
— Bulk of cell, bank dedicated to protein bioproduction
— Raw materials

Regulatory authorities are advancing support for NGS, it has the potential to replace existing in vitro/in vivo assays and molecular tests:

— It can be used in direct testing of cells, virus stocks, etc.
— Can be used as a readout of Bioassays
— Non-Hypothesis driven
— A broad range of detection
— Differentiate live from inert viruses

Fast time to release

Safety

Cost-effective offer

Expertise

3R compliance

— Faster Turnaround time than classical in-vivo/in-vitro assays
—  Clear Go/No-go decision support for lot release
—  Reduce time to patient and time to market
— Multiplexing capabilities (NGS throughput)
— High parallel computational capabilities

—  Patient safety-driven, de-risking bioproduction
  Validated protocols
— GLP certificate and in compliance with GMP (2021)
— Secured and back-up servers for data safety
— 5 years archiving
— Dedicated customer portal

—  State of the art technology
—  Comprehensive portfolio
— Outsourcing benefits: expertise without huge investments
— End-to-end services
— Customizable services

—  Unique Viral Database
—  AVDTIG member
— NIMBL member
 22 scientific publications
— Viral and genetic experts
— Actionable Report with expert reviewal

—  Potential of NGS to replace in-vivo testing’s
—  In accordance with Directive 2010/63/EU, Replacement, Reduction, Refinement needs to be considered when selecting testing approaches to be used for regulatory testing

Fast time to release

— Faster Turnaround time than classical in-vivo/in-vitro assays
—  Clear Go/No-go decision support for lot release
—  Reduce time to patient and time to market
— Multiplexing capabilities (NGS throughput)
— High parallel computational capabilities

Safety

—  Patient safety-driven, de-risking bioproduction
  Validated protocols
— GLP certificate and in compliance with GMP (2021)
— Secured and back-up servers for data safety
— 5 years archiving
— Dedicated customer portal

Cost-effective offer

—  State of the art technology
—  Comprehensive portfolio
— Outsourcing benefits: expertise without huge investments
— End-to-end services
— Customizable services

Expertise

—  Unique Viral Database
—  AVDTIG member
— NIMBL member
 22 scientific publications
— Viral and genetic experts
— Actionable Report with expert reviewal

3R compliance

—  Potential of NGS to replace in-vivo testing’s
—  In accordance with Directive 2010/63/EU, Replacement, Reduction, Refinement needs to be considered when selecting testing approaches to be used for regulatory testing

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Let’s Start Something New

Welcome to PathoQuest!