Cell & Gene Therapy CDMO Case Study

Preparing a CDMO for COVID-19 Vaccine Manufacturing Readiness

Cell & Gene Therapy CDMO Case Study

Preparing a CDMO for COVID-19 Vaccine Manufacturing Readiness

Cell & Gene Therapy CDMO Project Highlights

  • State-of-the-art cell and gene therapy contract manufacturing facility
  • Saved hundreds of thousands of dollars with careful budget management
  • Met all milestones with a streamlined project schedule
  • Completed the project in record time by involving all stakeholders
  • Enabled the facility to manufacture in record time leading to an approved product
Cell & Gene Therapy CDMO Case Study - Preparing a CDMO for COVID-19 Vaccine Manufacturing Readiness

Cell & Gene Therapy CDMO Project Highlights

  • State-of-the-art cell and gene therapy contract manufacturing facility
  • Saved hundreds of thousands of dollars with careful budget management
  • Met all milestones with a streamlined project schedule
  • Completed the project in record time by involving all stakeholders
  • Enabled the facility to manufacture in record time leading to an approved product

Long before the novel coronavirus SARS-CoV-2 became a global pandemic requiring rapid vaccine development and treatment exploration, a U.S.-based contract development and manufacturing organization had a vision: to bring more life-saving gene therapies to patients in need.

A years-long process to make that dream a reality in the form of a state-of the-art commercial manufacturing facility hit a snag when the facility readiness work was falling behind schedule and was projected to go well over budget with the validation firm that was hired.

That’s where ICQ came in.

“Without ICQ, we would not have met our timeline for facility readiness or been in a position to help with COVID vaccine production.”

Deborah Wild, Former Chief Quality and Regulatory Affairs Officer and Global Head of Client and Business Management

“ICQ has the most skilled staff of validation engineers I’ve ever encountered. Our C-suite had full confidence in ICQ’s team. We had no one of ICQ’s expertise on staff and no head of validation at the time. They augmented our staff with the right people to accelerate our timeline to readiness to welcome commercial clients for production.”

Deborah Wild, Former Chief Quality and Regulatory Affairs Officer and Global Head of Client and Business Management

“ICQ performed an audit of our facilities, quality systems, and operational readiness and outlined a simple yet thorough executable and effective strategy. They proceeded through the execution plan that exceeded expectations.”

Deborah Wild, Former Chief Quality and Regulatory Affairs Officer and Global Head of Client and Business Management

ICQ’s pragmatic approach to biopharma and life sciences commissioning, qualification, and validation projects was key to successfully completing the first phase of the gene therapy commercial facility build-out.

Our ground-breaking risk-based CQV strategies helped accelerate the project schedule and meet aggressive timeline milestones in an ever-evolving gene therapy compliance environment to finish ahead of schedule and under the anticipated budget. With the success of our first phase work, we earned bids to head the CQV work for phases 2 and 3.

Answering the Call with CQV Strengths

  • Ground-breaking risk-based CQV approaches for gene therapy applications
  • Industry-leading applicant sourcing platform allowed the client to choose from the most talented and qualified professionals available
  • Comprehensive, hands-on project controls successfully managed and reduced the budget scope and schedule
  • Vast knowledge of data integrity challenges and solutions for more efficient project execution
  • Ability to communicate with all builders, engineers, and other stakeholders in detail to coordinate schedules and make cross-functional improvements

Completion of the facility in 2019 came just in time, as the global outbreak of SARS-CoV-2 was just around the corner.

As a result of the facility’s innovative design and flexibility for cell and gene therapy production, the CDMO was an attractive choice for biopharmaceutical companies looking to rapidly develop, test, and manufacture critical COVID-19 vaccines and treatments.

The facility supports viral vectors, vaccines, and oncolytic immunotherapies from phase 3 through commercial manufacturing.

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

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