Purpose-Built Viral-Vector Facility Construction: Applying Quality and Engineering Controls

In this report, Avid shares its approach to producing high-quality, safe, and effective viral vectors for use in gene therapy and vaccine applications. The company is dedicated to minimizing the risks for, and associated high costs of cross-contamination and contamination during manufacture of viral-vector products. To this end, the contract development and manufacturing organization (CDMO) is establishing a rigorous quality control program as it completes its new facility. In 2021, Avid began building a 53,000-ft² site in Costa Mesa, CA, close to its main campus in Tustin, CA. The process development (PD) and analytical development laboratories were completed in 2022, and the good manufacturing practice (GMP) facility is expected to be ready in mid-2023.

The author summarizes how Avid designed engineering and quality controls to provide several layers of protection. He describes use of LoPA (layers of protection analysis) as a major tool in Avid’s risk-assessment toolbox. That enables the company to consider all potential failures in its viral-vector manufacturing process and to develop layers of controls to protect against cross-contamination. LoPA helps determine how robust the controls are and how many independent protection layers are needed. Such activities are vital to ensuring a safe and efficient manufacturing process.

Further examples include use of ionized hydrogen peroxide (iHP) for fumigation or decontamination processes and implementation of engineering and facility controls during GMP site construction. Among those controls are customized badge access, equipment that is color coded for viral-positive or viral-negative rooms, and a robust process to inactivate viral-positive biowaste.

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