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.
Sequence Scope: Commissioning and Equipment Qualification
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
What is Equipment Qualification?
Equipment qualification typically involves four critical steps: Qualification, Installation Qualification, Operational Qualification and Performance Qualification. These steps help ensure that all procedure documentation to operate and maintain the system are in place. Equipment qualification also involves the final inspection and testing of equipment to ensure that critical manufacturing requirements and guidelines outlined in the four step process are in place and being accurately followed. This is a vital step in ensuring product quality and specifications are routinely met.
How Does the Commissioning Process work?
The commissioning process for the pharmaceutical and biosciences industry focuses on creating a systematic approach to the start-up, renovation or turnover of facilities. This often includes ensuring that the equipment, processes and systems of the facility meet specific requirements and includes the confirmation of adequate water and power utility supply, HVAC systems, waste removal, etc. Anything that might affect the facilities’ ability to create a quality, replicable product is examined in commissioning.
Because the pharmaceutical and biosciences industries are so regulated, commissioning typically adheres to GMP regulations that involve not only equipment qualification but also qualification of all operations within the manufacturing process. Facilities must maintain and have traceable verification of the systems in place. Commissioning helps ensure that all equipment and systems are correctly installed and that the correct documentation is in place.
Before the commissioning process is instigated, it is important to have an overview of the system, facilities and equipment to be commissioned. The plan will detail the scope and sequence of strategies, project deliverables and the role of both the commissioning agent and the facility. Commissioning activities may include design reviews, factory acceptance testing, installation verification, and functional testing.