Lykan Bioscience Project Highlights
- Cell-based Therapy CDMO
- Hopkinton, MA
- 2020: Developed CQV strategy, performed IOQ, and ran cleanroom EMPQ
- Managed the qualification of all facility equipment and generated more than 4,000 pages of data, including protocols and reports
How It Started
Lykan Bioscience is a startup facility in Hopkinton, MA, that specializes in the development and manufacturing of cell-based therapies.
In June 2020, when they were nearing the end of their construction, the Lykan team realized that they needed some validation assistance.
One of Lykan’s founding team members had previously worked with ICQ’s President, Mike Bogan, and reached out for expert guidance.
Lykan brought ICQ in to help with three main goals:
- Assist in developing a Commissioning, Qualification, and Validation (CQV)
- Perform Installation and Operational Qualification (IOQ) on process equipment (primarily Temperature Controlled Units – TCUs).
- Develop, manage, execute, and report on Environmental Monitoring Performance Qualification (EMPQ) for their cleanroom areas.
The Game Plan
For the equipment IOQ efforts, ICQ provided a protocol template and the base qualification experience. We worked with the Lykan team to develop the template into a protocol that was functional for them.
Once that was in place, we worked with Lykan to qualify their equipment and manage the execution efforts to ensure that qualification was complete and executed data packages were assembled and provided to Lykan for on-time release of qualified equipment. All equipment in our scope consisted of Temperature Controlled Units (TCUs) – refrigerators, freezers (-20, -80), incubators, and cryofreezers.
For the EMPQ efforts, ICQ evaluated the cleanroom areas to develop a sampling plan and comprehensive protocol. We designed the protocol to evaluate cleaning performance (through viable surface samples), HVAC performance (through viable and non-viable air samples), and environmental control (temperature, humidity, and differential pressure) through a review of environmental monitoring system alarms during the testing period.
We vetted and brought in a contract sampling lab to assist with sample collection and worked together to develop a testing schedule.
Due to the size of the cleanrooms, we broke the area into three testing “phases” and had one protocol for each phase. During sampling, ICQ personnel were on-site to help manage personnel movement and ensure that testing was completed according to the schedule.
As sample results came in, ICQ reviewed and compiled all the data into executed protocol data packages and developed reports for each test phase.
Following approval of the final reports, ICQ provided continued support to correct minor documentation errors in the data packages and revise the reports following client audits of the EMPQ data.
In all, the project generated:
- 3,288 total particulate count (non-viable air) sample results
- 1,464 viable air sample results
- 4,728 viable surface sample results
- More than 4,000 pages of data (including protocols and reports)
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