2022
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PathoQuest boosts quality control of drugs using a cloud that complies with Good Manufacturing Practices (GMP)

Learn more about how PathoQuest uses Next-Generation Sequencing with the capabilities of the AWS Cloud.

Cloud infrastructure

complies with GMP for the pharmaceutical industry

Manual transactions

reduced from 7 hours to 30 minutes

IT workflows

reduced from 5 days to 1 day

Internationalization

easy through AWS regional infrastructures

Overview

PathoQuest, a spin-out of Institut Pasteur, offers quality control services to the pharmaceutical industry. Its NGS (next-generation sequencing) based tests reduce the drug control process for experimental or commercial release from 12 weeks to 4 weeks on average. To accomplish this, PathoQuest is able to quickly and easily deploy the IT and storage resources it needs, in the countries where it needs them, compliant with good manufacturing practices (GMP) governing the industry, through the Amazon Web Services cloud.

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Fortunately, the quality control procedures in the pharmaceutical industry are very standardized. To conduct quality control analyses in the cloud, we have to strictly respect GMP standards."

Jean-François Brepson
President & CEO, PathoQuest

Drug development is a lengthy and complex process, taking several years. The worldwide health crisis highlighted the need to speed up the process so that patients can receive the treatments they need quickly. And it’s precisely this challenge that PathoQuest is taking on. The French company offers quality control services to the pharmaceutical industry in order to ensure compliance of new drugs before they are marketed and administered. To accomplish this, the company relies on its next-generation sequencing (NGS) technology. PathoQuest collects a sample of a particular product through DNA extraction, then analyzes it to very accurately determine its nucleic composition. "The sequenced DNA is a very large data file," explains Jean-François Brepson, President & CEO of PathoQuest. “From this mass of information, our algorithms are able to identify the slightest trace of virus by comparing the information to our proprietary databases."

Whereas, normally, conventional techniques take 3 months to get a result, PathoQuest’s NGS technology takes only a few weeks. Faster but more comprehensive. “For example, a well-known PCR test targets only a limited number of viruses,” Jean-François Brepson explains. It’ll tell you if you have the coronavirus, but not if you have the flu. Our technology pragmatically detects all possible viral contaminations in a single sample.” A method that avoids viral safety testing on animals. In fact, many animals are injected with products in laboratories to test the effects, and the pharmaceutical industry is seeking alternative methods.

Automating transactions to focus on Innovation

The biotechnology industry is at the crossroads of medical research and technological innovation. Digital technology plays a key role in PathoQuest’s NGS process. "The test that we offer combines two worlds," says Jean-François Brepson. "We start by extracting DNA, in a molecular biology laboratory. Then we switch over to the world of big data." In fact, data processing requires significant computer power and storage scalability, since each analysis can require up to 150 GB of data. “The analysis building block that we offer functions only with a solid computer infrastructure to support it,” confirms Guillaume Deplaine, Head of Operations at PathoQuest. "We immediately contacted Amazon Web Services to build this infrastructure in the cloud to overcome constraints associated with hardware."

Using Amazon EC2 services for IT resources, Amazon S3 for secure storage capacities and Amazon KMS for data encryption saves the PathoQuest teams time. Besides outsourcing infrastructure management, the company’s programmers use AWS services to modernize workflows and to implement a high level of automation, which will reduce the time necessary to process an analysis transaction from 5 days to 1 day. This allows us to devote more time to higher added value tasks and to act as a real technological and innovative partner serving businesses. “Our goal is to automate as many transactions as possible," adds Guillaume Deplaine. "When an analysis is launched, we can accomplish 6 to 7 hours of manual work in about thirty minutes, while the volumes of data to process increase." The ultimate goal is to deliver quicker results to PathoQuest’s customers.

Complying with Good Manufacturing Practices, in the Cloud

Being a leader in bioproduction isn’t so simple. Even though PathoQuest does not handle patients’ personal health data, the regulatory constraints are still strict. “It’s not about simply taking data and sending it to the cloud," notes Sebastien Renouf, Chief Pharmaceutical Officer of PathoQuest. "The quality control procedures in the pharmaceutical industry are extremely standardized. To conduct a pharmaceutical test in the cloud, we have to implement proven systems, secure storage, qualified equipment, and trained teams to comply with good manufacturing practices (GMP)."

Relying on AWS services such as AWS Config and the GxP conformance pack, which provide a compliance framework, PathoQuest can remotely deploy its GMP-compliant methods to the cloud. “We must never lose sight of the fact that we are working on manufacturing a drug," Sébastien Renouf points out. "What our customers need to know is if the drugs they develop are safe and can be administered to patients. The analysis must be simplified. And our duty is to ensure that if we move the analysis process to the cloud, this solution will remain valid." Today, PathoQuest conducts daily and routine regulated and non-regulated studies on the Amazon Web Services cloud.

Deploying Resources Close to Customers

The next step is now to implement a similar strategy in the United States. On October 4, 2022, PathoQuest opened its new quality control facility in Wayne, Pennsylvania. The company invested $10 million in this facility to serve this new key market, and has started conducting analyses. PathoQuest can simply deploy the IT resources it needs locally to process requests from overseas customers through access to AWS infrastructures in the US East (Northern Virginia) region. “We’re not talking about an insignificant change," concludes Sébastien Renouf. "It’s a major transformation for the industry. We want to continue to be NGS pioneers, serving the French and worldwide industries."


About PathoQuest

PathoQuest is a French service provider for the pharmaceutical industry, offering quality control testing of biologics, such as gene and cell therapies, vaccines, or antibodies. Its technology is based on next-generation sequencing (NGS).

AWS services used

Amazon EC2

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Amazon S3

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