Akadeum’s CDMO Alliance is an exclusive consortium of leading companies who have evaluated and integrated Akadeum’s GMP-grade, scalable microbubble kits for commercial manufacturing. The CDMOs are positioned to help you manufacture your therapeutic in a cost-effective, time-saving manner with the use of microbubbles.
Being Bubble Certified is a seal of approval and a competitive edge. Membership in the Akadeum CDMO Alliance demonstrates the CDMO is equipped to deliver superior outcomes in cell therapy manufacturing while reducing costs and streamlining workflows. CDMO Alliance members have early access to kits in development, enabling earlier discussions for new indications. Member companies also have Akadeum’s regulatory and tech support teams available when they need it, whether remote or in person.
Achieve the benefit of microbubbles with our CDMO Alliance:
Akadeum’s microbubble technology is designed to address common cell therapy manufacturing bottlenecks, delivering higher-quality cells and faster workflows compared to traditional magnetics-based methods. Key advantages demonstrated in CDMO Alliance member application notes and webinars include:
Utilizing microbubble kits in cell therapy workflows can reduce overall workflow time by up to 37% and provide up to twice as many therapeutic cells—with cost savings recognized by a smaller GMP suite space and no additional capital equipment expenses.
Akadeum’s technology scales consistently from 50 million to 50+ billion cells per run, enabling CDMOs to move smoothly from supporting development efforts and pivotal stage trials through commercial scale GMP manufacturing, with the same reagents and processes. This scalability ensures reliable performance at every stage of the drug development process through commercialization, eliminating change concerns and streamlining the process for raw material validations.
GMP Microbubbles are fully compatible with cell washing systems but can also be utilized instrument-free, including processing in apheresis material bags, and leveraging common sterile tube welders. GMP-grade kits offer sterility, endotoxin and viral release testing and follow a stringent documentation process, facilitating seamless adoption in regulated environments.
Buoyancy-based GMP microbubbles can scale to up to 50 billion cells without equipment, are more gentle resulting in better viability (a major contributor to potency and persistence), and up to 80% faster with isolation under an hour and the ability to cut expansion times by days—all critical attributes for therapies where every cell counts.
Yes. Akadeum’s GMP kits are validated in CAR-T therapy workflows. They provide high-quality starting material that supports consistent, reproducible therapeutic products. Note it is up to the sponsor to determine fit for use in their specific workflow.
Akadeum’s GMP kits are manufactured under compliance with GMP standards 21 CFR 820, 210 and 211. Akadeum’s GMP kits are Ancillary Materials for Cell and Gene Therapy, and are compliant with ISO 20399 and USP <1043>, among other standards for viral testing and residual solvents. Biocompatibility and extractables testing has been completed on the microbubbles per ISO 10993.
A Drug Master File is available and can be amended to support a custom application, if necessary. Please contact Akadeum for more information. Akadeum works with Dark Horse Consulting for regulatory support.
Unlike magnetic methods, microbubbles use gentle buoyancy for separation. This instrument-free approach has demonstrated a significant ROI of up to 40% in cost savings (workflow dependent) and is scalable while preserving cell health—giving CDMOs a unique edge in manufacturing efficiency and therapeutic quality. Simplicity in use reduces training and implementation timelines.
Yes. By reducing workflow steps to save time (labor and facility cost impacts) and complexity (lower the risk of failed runs), improving yields (more cells saves time), enabling industry leading potency and persistence of cells (reduce risk), and eliminating the need for new equipment (saving capital equipment and facility costs), GMP microbubble kits help CDMOs lower operational costs while delivering better outcomes faster.
The Akadeum CDMO Alliance is built to support organizations ready to move from R&D to commercialization, to scale their capability in cell therapy manufacturing quickly and cost-effectively. By utilizing the Alliance CDMO capabilities, your company will gain access to innovation, experience the ROI of microbubbles, and receive dedicated technical support from the CDMO and Akadeum teams—all powered by Akadeum’s microbubble technology.
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