AM Technical Solutions (AM) is currently leading a facility expansion project to support a biotechnology company’s critical research efforts for life-saving cell and gene therapies.
The customer needed to accelerate their timeline for expanding clinical and commercial manufacturing space to support an emerging need for process and product development. Our role in the project is to help lead the facility startup, commissioning, and qualification of the facility expansion.
The result will be a start-of-the-art contract manufacturing facility to help researchers push forward with innovative therapeutics. We have been asked to lead this effort in an efficient and compliant manner with a focus on schedule, cost, functionality, and quality.
Project Scope for the Facility Expansion Project
Our team has been asked to provide technical leadership and leverage our experience to support the customer’s facility expansion plans. We have also been asked to assist with their production facility utilities, which includes the development of lifecycle documents to the final review of executed Commissioning and Validation protocols.
A key aspect of the project is that we will be providing a Commissioning and Qualification Subject Matter Expert (SME) to work with the customer’s facility startup, commissioning, and validation teams.
In total, we have been asked to provide the following support for critical aspects of the facility startup, commission, and qualification:
- Understanding the minutiae of each system’s capability, and to decipher what components or operations are critical for commissioning or validation qualifications.
- Helping to Identify any gaps in the project lifecycle document process and making recommendations to ensure that they align with industry standards and regulations.
- Utilizing validation experiences to understand what testing is required within commissioning documents if they’re to be leveraged for validation purposes.
- Leading, coordinating, and assisting the project commissioning team to facilitate delivery of the project on-time, at-cost, and with quality and functionality project success.
Additionally, our original project scope has been expanded for us to assist with the coordination and review of validation protocols and equipment delivery of their process equipment.
“We are confident that our expertise and our collaborative approach to project delivery will lead to the successful completion of the facility expansion,” says Brian Williams, SVP, AM Life Science. “Once the project is complete, the customer will be armed with the latest tools to support innovation and accelerate the development of life-saving therapies.”
- Find out more about our capabilities to deliver solutions for life science projects.
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- Need support with facility startup, commissioning, and qualification? Contact us today to discuss your project needs.