ABSTRACT
Background/Case Studies: Clinical-grade cell manufacturing must be performed in an environment designed to prevent contamination or introduction of communicable diseases into the product. For an institution seeking to add clinical-grade cell manufacturing capabilities to augment existing facility capabilities, a modular cleanroom may be a practical option. We report on the installation and certification of a 140 x 100 cleanroom with a 60 x 60 gowning chamber at a newborn stem cell bank. Study Design/Methods: A modular cleanroom and antechamber were ordered from the manufacturer and delivered in crates. After installation of epoxy flooring by an outside vendor, cleanroom assembly was completed inside an existing warehouse environment with common power tools by a three-person team in approximately two weeks. Cleanroom equipment was installed over three weeks, and the cleanroom and gowning chamber were certified to the specified ISO classification within two months. Weekly cleanroom cleaning and biweekly environmental monitoring were implemented and are ongoing. Results/Findings: Assembly of the cleanroom was accomplished by an in-house team per the manufacturer's instructions. Following installation, the cleanroom and gowning chamber were certified by a vendor at ISO Class 7 and 8, respectively. Measurements for air changes per hour and airborne particulate counts obtained during certification indicate that each room was well within the requirements for its certification level (Table 1). Based on this data, certification of the cleanroom at ISO Class 5 could be possible, if required. Bi-weekly environmental monitoring showed no breaches of action limits for viable air sampling, including for periods during which cell processing activities were performed. Conclusions: Development and maintenance of an appropriate processing environment can be a hurdle to the implementation of clinical-grade cell manufacturing. Our experience demonstrates that a modular, off-theshelf cleanroom is a suitable alternative to a permanent cleanroom. Proceeding from installation through certification at ISO-7 within four months was especially valuable during the constraints of the COVID-19 pandemic. Along with sterile gowning procedures, routine cleaning, and environmental monitoring, the cleanroom provides a suitable environment designated specifically for isolation and expansion of cGMP compliant MSCs from umbilical cord tissue previously cryopreserved as a composite material for use in partnered IND-enabling and process development studies to facilitate submission of IND applications to the FDA.