Project Basecamp: Lab Instrument Qualification
Cell & Gene Therapy
With more than 140,000 square feet of space, ElevateBio BaseCamp includes current Good Manufacturing Practice (cGMP) manufacturing suites, analytics, and quality control (QC) laboratories, and protein engineering, virology, and immunology labs, all with state-of-the-art laboratory automation. BaseCamp was designed to support diverse gene and cell regenerative therapy products, with manufacturing suites that have flexible floor plans for cGMP manufacturing. The facility has autologous, allogeneic, and regenerative medicine cell products such as induced pluripotent stem cells, or iPSC, and viral vector manufacturing capabilities. Additionally, the BaseCamp cGMP manufacturing suite environment, equipment, and processes are monitored by validated and integrated computer systems.
Sequence Scope: Instrument Qualification
On this project, Sequence was responsible for developing a site validation program for the Manufacturing and Laboratory space including laboratory instrument qualification. After the implementation of the new validation program, the project consisted of various system CQV activities for the start-up of the laboratory space. The current lab footprint has expanded resulting in expansion efforts for additional CQV projects.
- Developed site Validation program for QC and MFG assets, including risk-based validation plan to facilitate efficient qualification of assets in the QC Lab and Manufacturing GxP space.
- Developed Analytical Assets and Test Method Validation Master Plan for the newly constructed Gene/Cell Therapy facility.
- Created lifecycle forms/templates to assist with document/SOP development for site implementation (i.e. VMP,SIA, RRA/ERES, VP, RS, IOPQ, TM, VSR, Periodic Review, Admin SOP)
- Coordinated all vendor scheduling and installations, including procurement of quotations for instrument and software upgrades.
- Managed and reported overall project finances, resource plans, and deliverable completion metrics.
- Developed Kneat templates for QC to streamline validation process by using family approach testing strategy.
ElevateBio BaseCamp is a dedicated cell and gene therapy research, process development, and production center that addresses the primary obstacles in cell and gene therapy and regenerative medicine: integrated research, process development and manufacturing.
Manufacturing production plans for the facility at this stage include two companies: AlloVir, which is developing a T-cell therapy that targets multiple viruses, and HighPassBio, which is working on a T-cell receptor treatment for leukemia. Source
What is Analytical Instrument Qualification?
Analytical Instrument Qualification is the documented collection of activities necessary to establish that an instrument is delivered as designed and specified. All lab instruments should be qualified to demonstrate suitability for the intended use as part of the foundation of all quality analytical work. Instrument qualification is crucial for compliance in the pharmaceutical industry as it ensures regulatory compliance, maintains data integrity, supports quality control, manages risks, and aligns with Good Laboratory Practices. By implementing instrument qualification processes, laboratories can enhance the reliability and credibility of their operations, ultimately contributing to the safety and effectiveness of pharmaceutical products.
By utilizing qualified instruments and retaining the documents required for compliance, cell & gene therapy manufacturing facilities can speed the time to market and ensure that FDA compliance requirements are met.