COVID-19 Testing Lab Case Study

Fast Action Gets COVID-19 Testing Lab Ready for National Work

COVID-19 Testing Lab Case Study

Fast Action Gets COVID-19 Testing Lab Ready for National Work

COVID-19 Testing Lab Project Highlights

  • Automated, high-throughput COVID-19 diagnostic testing laboratory
  • Supported lab build-out with a dedicated team of on-site validation engineers
  • Readied the lab to achieve Emergency Use Authorization status

If the biopharma industry had a motto for 2020, it might have been “fast and flexible.” As any organization that had applications relevant to the SARS-CoV-2 pandemic can attest, operations had to pivot quickly — often multiple times — in response to changing demands.

COVID-19 Testing Lab Case Study - Fast Action Gets COVID-19 Testing Lab Ready for National Work

COVID-19 Testing Lab Project Highlights

  • Automated, high-throughput COVID-19 diagnostic testing laboratory
  • Supported lab build-out with a dedicated team of on-site validation engineers
  • Readied the lab to achieve Emergency Use Authorization status

If the biopharma industry had a motto for 2020, it might have been “fast and flexible.” As any organization that had applications relevant to the SARS-CoV-2 pandemic can attest, operations had to pivot quickly — often multiple times — in response to changing demands.

The same was true for our Boston-area client that retrofitted an existing space to fill an immediate need for accurate and expedited COVID-19 diagnostic testing with a special focus on a campaign to test the nation’s teachers and students.

The lab was completing a phase 3 build out of a completely automated lab capable of running 150,000+ saliva samples per day through a system of 55 individual units — including buffer management, centrifugation, and chromatography — connected by an intelligent MagneMotion conveyor system.

With equipment commissioned and quality control testing underway, our biosecurity client realized an immediate need to supplement their team with experienced validation engineers who could validate the new equipment and software while building a foundation for Good Manufacturing Practices.

“A heartfelt thanks for wrapping this up!”

Automation Architect

“The CLIA & GxP gap analysis are quite useful to us in understanding how to tackle future regulatory hurdles; the index of organized documents, manuals, and drawings are fantastic as well for a future knowledge base for the facility.”

Automation Architect

“The CLIA & GxP gap analysis are quite useful to us in understanding how to tackle future regulatory hurdles; the index of organized documents, manuals, and drawings are fantastic as well for a future knowledge base for the facility.”

Automation Architect

After working with ICQ at his previous organization, the Senior Group Product Manager knew to reach out to ICQ to get his validation done correctly and efficiently by experts well-versed in GMP. Although we were there to assist with acquiring Emergency Use Authorization, we delivered detailed validation protocols that would also be helpful when going further to prove GMP compliance.

In the first phase of the validation project, ICQ:

  • Ensured all equipment was installed to specification
  • Validated the equipment operated as intended by the vendors
  • Confirmed all computerized systems communicated with each other and upheld 21 CFR Part 11 data integrity standards
  • Ensured start-to-finish sample traceability

Now that the demand for COVID-19 diagnostic testing has decreased, our client is retrofitting the lab space to apply their technology to other biologic sampling and tracking needs.

“My team of validation specialists maintained exceptionally high standards for process validation and computer system validation while working in a time-sensitive environment with other external teams to get the lab up and running.”

Gary LaPlante, Managing Consultant, ICQ

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Integrated Commissioning & Qualification Corporation (ICQ) is a leading provider of commissioning, qualification and validation services.

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Phone: (508) 970-8421
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