AM Life Sciences, a division of AM Technical Solutions (AM), recently completed a significant project supporting innovative gene and cell therapy research.
A Cell and Gene Therapy (CGT) company approached us to perform sample collection for analysis to support their commissioning and validation program at the company’s large biopharmaceutical facility in the Eastern U.S.
We were asked to deliver a team of qualified technicians to collect several hundred samples for analysis. We were also responsible for the management, coordination, and logistics of the project.
Capable of Navigating Cleanroom Challenges in Biopharma
The primary challenge associated with this project was performing the process gas sampling in a cleanroom environment to prevent the contamination of the samples.
We met this challenge head-on. Our team of experts were already familiar with working in cleanroom environments that are common in high-tech and biopharma facilities. Specifically, our team members are trained in aseptic techniques that are required to collect the different samples without contamination.
Being able to control environmental contaminants for systems that provide mediums to manufacturing processes is critical to the quality and compliance of those processes. We were pleased to complete the project without issues, and we provided the company with the final comprehensive reports detailing the results of the sample analysis for their facility.
“Any time that we can support biopharmaceutical companies with the important mission of delivering on life-saving therapies, we are pleased to apply our expertise,” says Robert McAndrews, VP, Global Accounts. “We appreciate that our customer has already reached out to us again to support them on future projects at other facilities in the U.S.”
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