Project Key: Commissioning and Equipment Qualification
Cell & Gene Therapy
Headquartered in Cambridge, MA, Brammer Bio’s facility includes a 66,000-square-foot Phase III and commercial CGMP viral vector manufacturing site. This was facility was designed to accommodate spatially segregated viral vector processing in dedicated production suites to support early phase clinical trials. In 2019, Brammer Bio was purchased by Thermo Fisher Scientific.
The client renovated an existing biologic manufacturing facility into a new gene therapy viral vector manufacturing facility. Sequence scope included CQV for equipment including but not limited to incubators, biosafety cabinets, single-use bioreactors, single-use mix tanks, depth filtration, single-use chromatography skids, single-use TFF skids, drug product filler and drug product isolator.
Sequence was responsible for developing project plans for facilities, utilities, and process equipment followed by risk assessments, site procedures, and start up efforts to qualify the site to allow for production of viral vector products.
Life cycle documentation was developed and executed to demonstrate proper functionality per specifications for systems such as Membrane-based WFI generation skid, VHP, HVAC, Compressed Gases (O2, N2, CO2, Air), and indirect impact systems (tempered water, plant steam, chilled glycol, etc.
Thermo Fisher produces and tests viral vectors for cell and gene therapy with adherent and suspension cell culture processes, a variety of chromatography and filtration purification processes and a state-of-the-art isolator and integrated fill system.
With years of experience producing cGMP viral vectors, they support a broad range of viral vector manufacturing platforms for gene and gene-modified cell therapies and vaccines including AAV, Adenovirus, Lentivirus, HSV, and Retrovirus. Source