Akadeum Life Sciences Announces Drug Master File Submission to the US FDA for GMP Microbubble Cell Separation
Published on Nov 17, 2025 Share
Akadeum Life Sciences, the leader in buoyant cell separation, announced today that it has submitted a Type II Drug Master File (DMF) to the U.S. Food and Drug Administration (FDA) for its GMP BACS™ Microbubble Cell Separation products. The DMF represents Akadeum’s strong commitment to delivering high-quality cell isolation products for cell therapy workflows, ongoing adherence to standards for Ancillary Materials in Cell and Gene Therapy, and support of customers actively pursuing clinical trials with Akadeum’s microbubbles.
Dedicated Compliance with International Standards
Akadeum has been successfully customer-audited per US and EU GMP standards, and the products meet endotoxin, sterility, and viral requirements per USP and ICH standards. As expected for raw materials in cell therapy, Akadeum’s compliance extends to USP <1043>, ISO 20399, and ISO 10993 for biocompatibility and extractables testing, in addition to other relevant ICH and ISO standards.
“As a supplier of critical ancillary materials, submitting the Drug Master File to the US FDA is a testament to Akadeum’s commitment to GMP, well-characterized products, and routine engagement with regulatory authorities in support of our clinical customers, reinforcing confidence in the safety and reliability of the materials we provide,” stated Akadeum’s Chief Operating Officer, Vanessa Kelchner. “We appreciate the support received from Dark Horse Consulting in achieving this important milestone”.
Akadeum’s Microbubbles Deliver Quality and ROI for Cell Therapy Workflows
In addition to regulatory support and compliance, Akadeum’s Human T Cell Leukopak Isolation Kit-GMP presents a significant advancement for healthier cells with its patented microbubble technology. Leveraging buoyancy, microbubbles effectively float unwanted cells to the surface, a negative selection approach that provides truly untouched cells, leading to enhanced cell viability, reduced expansion times, and increased potency without the need for additional cell separation equipment. This workflow ROI contributes to:
- Reduction of expansion time from 9 days to 5 days reduces cellular exhaustion risk and saves up to 30% in facility and labor costs
- Reduced rate of run failure – buoyant cell separation in under an hour is a gentle approach to maintaining healthier cells and providing increased potency
- Implementation anywhere – decentralized, modular, single day manufacturing applications are utilizing microbubbles that save up to 75% on equipment costs
- An overall cost savings of up to 40% in cell therapy workflows supports the goal of affordable therapeutics for greater access
Combining ROI with the Drug Master File enables cell therapy developers and manufacturers to work confidently to increase access to life-saving therapeutics while reducing costs, and knowing the product is backed by strong regulatory diligence and support.
Companies interested in obtaining a Letter of Authorization for the DMF are encouraged to contact Akadeum at quality@akadeum.com.
About Akadeum Life Sciences
Akadeum Life Sciences is dedicated to advancing cell separation technology through its unique buoyant microbubble platform. This platform enables researchers and manufacturers to achieve higher yields, better purity, and improved process simplicity across a range of life science applications. Our mission is to create separation technologies to advance human health. We envision a world where innovative separations empower researchers and clinicians to unlock breakthroughs in diagnostics, therapeutics, and basic research.