Genesis converted 2seventy bio’s existing office space into a purposeful cGMP clinical facility, essential for the advancement of their CAR-T cell therapy drug product. Within this context, the Genesis team played a pivotal role in guiding the intricacies of the construction and procurement processes.
By carefully mapping out equipment and process requirements at an early stage, our approach demonstrated foresight and meticulous planning. In line with regulatory standards set by FDA and EMEA, we strategically formulated cGMP-compliant workflows, seamlessly aligning personnel, materials, waste, equipment, and product flows. This harmonized design not only expedited the project’s timeline but also ensured adherence to stringent quality criteria.
The resulting clinical space accommodates various functionalities, including two ISO-7/Grade B process suites linked by supply and return corridors. Alongside these, we established a cGMP warehouse for storage, a controlled rate freezer and drug product room, as well as specialized areas like debox and waste rooms, lockers and gowning sections. Additionally, the layout includes spaces for media preparation and kitting, an ISO-7/Grade B Peripheral Blood Mononuclear Cell (PBMC) suite, a QC lab, document storage, clean equipment quarters, and utility infrastructure.
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- cGMP (Current Good Manufacturing Practice): Regulatory guidelines that ensure the proper design, monitoring, and control of manufacturing processes and facilities.
- CAR-T Cell Therapy: A type of treatment in which a patient’s T cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells.
- Pre-clinical and Phase 1/2a Clinical Trials: Stages of drug testing that occur before a new drug is made available to the general public. Pre-clinical refers to tests on cells and animals, while Phase 1/2a trials involve its first uses in humans.