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Akadeum Life Sciences Announces Establishment of the Akadeum CDMO Alliance Program

Published on Dec 8, 2025

CDMO Alliance

Akadeum Life Sciences, the leader in buoyant cell separation, announces the establishment of the Akadeum CDMO Alliance™ and the first two members in the consortium. The exclusive Akadeum CDMO Alliance builds on the strong relationships Akadeum has built with leading CDMOs in the cell therapy space and seeks to be a bastion for innovation in reducing costs, time, and access to cell therapies while delivering best-in-class performance. Inaugural Members of …

Akadeum to Highlight Latest Accomplishments for Microbubble Cell Separation at Biotech Showcase 2026

Event Start Date: JAN 12, 2026

Biotech Showcase

Akadeum Life Sciences CEO, Dr. Brandon McNaughton, is scheduled to present the at the 2026 Biotech Showcase™ in San Francisco, CA. McNaughton will highlight robust data, regulatory achievements, and compelling ROI figures for Akadeum’s patented microbubble cell separation technology. Since last year’s presentation, Akadeum has collaborated with Charles River, Lonza, MaxCyte, ElevateBio, and other industry leaders to generate new data showing how Akadeum’s buoyancy-based microbubble technology outperforms traditional magnetic methods …

From Safety Testing to Documentation: Building a Drug Master File That Speeds Approval

Published on Dec 2, 2025

Akadeum Scientist working in lab

Regulatory documentation is often a critical bottleneck on the path from therapeutic discovery to market. Every reagent, buffer, and consumable used in manufacturing must be accounted for, and incomplete records can delay Investigational New Drug (IND) approval. In cell therapy manufacturing, this is especially true for ancillary materials—the reagents and materials that come into contact with patient-derived cells during isolation, activation, and expansion. Although ancillary materials are not part of …

Ancillary Materials in Cell Therapy Manufacturing

Updated on Dec 2, 2025 | Published on Nov 30, 2025

Akadeum Scientist in Lab

In cell and gene therapy manufacturing, understanding each raw material input is critical to patient safety and therapeutic success. Ancillary materials (AMs) are the reagents, buffers, and biologic process aids used during cell manipulation, purification, and expansion. Although they do not remain in the final product, AM quality directly impacts consistency, safety, and regulatory approval. As manufacturing scales from discovery to commercialization, qualifying these materials appropriately can mean the difference …

Akadeum Life Sciences Announces Drug Master File Submission to the US FDA for GMP Microbubble Cell Separation

Published on Nov 17, 2025

GMP Kit

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 …

How Akadeum Microbubbles Work

Published on Oct 28, 2025

Discover how Akadeum’s microbubble technology works in just four simple steps that deliver healthier, more potent cells for cell therapy manufacturing. Capable of processing over 50 billion cells in under an hour, Akadeum microbubbles enable gentle, scalable isolation and depletion directly in-bag or within closed systems. Designed for flexibility, microbubbles integrate seamlessly with industry-leading platforms like Cocoon®, Rotea™, Sepax™, and ExPERT GTx™, supporting workflows from research to manufacturing scale. See …

Improving Cell Separation for Better Therapies and Greater Access

Published on Oct 28, 2025

Akadeum CEO Brandon McNaughton returns to Cell & Gene’s Meeting on the Mesa to present significant regulatory accomplishments, clinical milestones, and recent data from industry collaborators demonstrating how better cell separation is the key to better therapies. Presentation Highlights: Akadeum’s microbubble-based cell separation technology is the first and only separation technology that works entirely “in bag” for untouched, negative selection without the need for magnetics and is compatible with industry-leading …

Streamlined, Closed System, In-Bag Cell Separation With Akadeum’s Human T Cell Leukopak Isolation Kit – GMP and Cytiva’s Sepax Cell Processing Instrument

Published on Oct 21, 2025

Akadeum’s buoyancy-based cell separation allows for an unique in-bag negative selection protocol that can be easily integrated into workflows that already incorporate cell processing equipment, such as the Cytiva Sepax. A Sepax-integrated workflow with Akadeum technology allows for a closed system process that can be scaled to meet any and all manufacturing needs. Utilizing standard Sepax protocols, Akadeum’s Human T Cell Leukopak Isolation Kit – GMP protocol can be initiated …

Akadeum Life Sciences and BioIVT Collaborate to Provide Robust Starting Material to Developers of Cell Therapy Products

Updated on Oct 21, 2025 | Published on Oct 14, 2025

BioIVT Logo

Akadeum Life Sciences, the pioneer in gentle buoyant cell separation technology, and BioIVT, a leading global provider of high-quality biological specimens & research services, announce a collaboration aimed at providing healthier T cells via better qualified starting material, for developers and manufacturers of cell therapy products. As cell therapies are complex, the process is important to the success of the product – high-quality starting material is a critical first step …

Akadeum Life Sciences to Provide Clinical & Tech Updates, Moderate Panel Alongside Industry Leaders at Cell & Gene Meeting on the Mesa

Published on Oct 2, 2025

Akadeum Life Sciences to Provide Clinical & Tech Updates, Moderate Panel Alongside Industry Leaders at Cell & Gene Meeting on the Mesa

Akadeum Life Sciences, a leader in buoyancy-based cell separation technology, will present significant milestone updates of its next-generation cell isolation microbubble technology at the annual Cell & Gene Meeting on the Mesa, taking place October 6–8, 2025, at the historic Arizona Biltmore Resort. Akadeum will also moderate a high-profile Science Slam session with industry leaders on the topic of improving the time and cost to develop therapeutics. On Monday, October 6th, at 4:00 …

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