Clinical Manufacturing Facility Design + Pre-con
CRB provided all architectural and engineering design, as well as early pre-construction support, for Pfizer’s Andover Clinical Manufacturing Facility. The ACMF will produce CGMP compliant clinical drug substances. Beginning with concept design in fall of 2015, the design was accelerated to allow an aggressive start to construction in April 2016.
The new facility was online, producing cGMP compliant clinical drug substance, within 36 months to replace the current manufacturing facility in St. Louis, Missouri
The new clinical manufacturing facility is designed with five independent manufacturing suites to support Pfizer’s highly complex and diverse biologics research effort. The facility:
- Employs flexible design to fully enable Next Generation Manufacturing strategies.
- Leverages state-of-the-art single-use bioreactors and disposable process technologies.
- Provides clinical manufacturing options with the lowest cost and greatest flexibility for efficiently driving important clinical drugs to patients.
Specific cell culture and microbial capabilities were designed as follows:
- Suites 1-3: Cell culture manufacturing with single use equipment through the bioreactor stage. Two suites will be at 1000L scale and one at 2000L scale. Cell harvest will be via centrifugation. Stainless steel flow paths will be utilized for chromatography and ultrafiltration.
- Suite 4: Cell culture manufacturing with single use up to 100L expansion and SS at 250L and 1000L scale. The purification strategy will be centrifugation with stainless flow paths for chromatography and ultrafiltration.
- Suite 5: Designed to run microbial fermentation with oxygen uptake. Bioreactors will be 150L and 1000L scale. Cell disruption will be via homogenization and capability will include centrifugation and vessels for refolding. Purification concepts will be similar to suites 1-4. The bioreactors will be capable of being converted for cell culture operations.
- Suites are flexible in configuration to accommodate future processes which will include perfusion of seed reactors, hybrid perfusion and fed batch bioreactor concepts.
- Media and Buffer distribution will be via totes utilizing single use bags. No transfer panels will be utilized.
- Media and Buffer prep are to be readily expandable for future operations. Platform technologies for single use systems by GE Health Care are being utilized. Upstream utilization of “Flex Factory” and GE’s AKTA chromatography in downstream are being considered.
Pfizer wanted to align the Clinical Manufacturing Facility and biologics commercial manufacturing worldwide on Emerson’s Delta V control platform. This syncronization in Andover is progressed in stages to this platform and CRB ensured that the Clinical Manufacturing building and operation is in alignment with the existing site movement where there is shared infrastructure.
The facility was operational by the beginning of 2019.