Moderna Project Highlights
- Norwood, MA
- September 2020 – present
- Helped build a 1,700-square-foot quality control (QC) lab and manage nearly 30 instruments
- Continued partnership across various internal Moderna teams
An Urgent Need for A New Facility
In September 2020, Moderna needed to build a brand-new 1,700-square-foot laboratory that would house nearly 30 instruments.
However, they didn’t have a lot of staff at the time. It was the height of the COVID-19 pandemic, and they were working at light speed. After moving from phase 2 clinical to commercial GMP in nine months (typically a 10-year process!), they experienced growing pains, and many of their systems needed upgrading immediately.
They were looking for a partner with a wide range of knowledge—especially about process validation—to get the lab up and running.
One of Moderna’s leaders had a personal connection with ICQ’s Northeast Regional Director, Michael Murphy, and knew he and the rest of ICQ had the right experience to do the job.
Helping Moderna’s Internal Quality Control Team
In addition to managing the construction of their new facility, we helped Moderna’s QC team get their system ownership documentation squared away for all of their releases.
We guided their team and assisted with the execution of the day-to-day activities required to manage so many pieces of equipment.
These activities and guidance include:
- Understanding the equipment life cycle
- Pipetting calibrations
- Updating standard operating procedures (SOPs)
To date, ICQ has helped Moderna release hundreds of instruments.
Moderna and ICQ: A Continued Partnership
After the initial laboratory build, Moderna expanded operations and purchased the 75,000-square-foot building next to the new laboratory, which houses around 470 instruments.
They continued our partnership and brought many of our resources into their internal teams, where they still work today.
These teams include:
- Computer system validation (CSV)
- Equipment validation
Interested in hearing more success stories? Check out our case studies.
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