Regulatory Support for Cell Therapy Manufacturing
Akadeum helps cell and gene therapy developers meet global regulatory requirements with confidence. Akadeum’s microbubble cell separation kits are manufactured under a Quality Management System aligned with ISO 13485 for Medical Devices and ISO 14971 Risk Management standards and compliant with GMP requirements under FDA 21 CFR Parts 11, 211, and 820. Each process—from raw material qualification to final lot release—is designed with the ultimate goal in mind of enabling reproducible and reliable results for cell therapy manufacturing.
Quality and Transparency You Can Trust
Akadeum Life Sciences is committed to delivering high-quality cell separation products designed for safe and effective use in research and clinical trials. We prioritize product safety, regulatory compliance, and continuous improvement through a rigorous quality management system. Our commitment to excellence ensures that our products meet the highest standards for reliability and performance, supporting scientists and clinicians in achieving safe, reproducible, and impactful results.
Our commitment to quality includes:
- GMP and ISO 13485 compliant Quality Management System
- Controlled cleanroom manufacturing and validated processes
- Comprehensive raw material traceability and supplier qualification
- Certificates of Analysis (CoA) provided with every lot
- In-process and release testing for performance, sterility, endotoxins, and viruses
- Dedicated quality oversight and continuous improvement programs
GMP Manufacturing Support from Research to Commercial Scale
Akadeum’s microbubble kits are designed for seamless transition from R&D to GMP manufacturing. Identical formulations across research-use and GMP-grade kits allow teams to scale processes without revalidation.
The simplicity of buoyancy-based separation makes Akadeum’s kits inherently compatible with both manual and automated closed systems, reducing the number of operator touchpoints and maintaining exceptional cell health. Buoyant cell separation reduces the need for additional cell separation equipment, resulting in lower capital equipment and facilities expenses and reduced labor requirements. Scaling from hundreds of millions of cells in research through tens of billions at commercial scale with the same reagents without added expenses is possible with microbubbles.
Regulatory Documentation and Support Materials
Akadeum provides detailed documentation to support audits, regulatory submissions, and process qualification activities. All products are backed by validated specifications, test data, and certificates designed to meet the expectations of global health authorities:
- Drug Master File (DMF) Letter of Authorization (upon request)
- Certificate of Analysis (CoA) and Certificate of Origin (CoO, where applicable)
- Product Information File
- Material Safety Data Sheets (MSDS/SDS)
- Regulatory and quality statements (e.g., Animal-Origin Free, USP <1043> Ancillary Materials, USP Class VI compliance)
- Protocol for residual enumeration
Ancillary Material Qualification
Regulatory agencies require qualification of ancillary materials used in cell therapy development and manufacturing. Ancillary materials are reagents used during manufacturing that are not intended for inclusion in the final product. Akadeum’s microbubble reagents are developed and manufactured to meet these expectations while simplifying customer qualification processes.
Key considerations for ancillary material use:
- Meets USP <1043> and ISO 20399:2022 standards for ancillary materials
- Tested per ISO 10993 biocompatibility and ICH Q3D(R2) elemental impurity guidelines
- Validated per USP <71> sterility, USP <85> endotoxin, and ICH Q5A(R2) viral testing
- Animal-origin–free formulations, where applicable
- Full traceability and supplier qualification documentation
By meeting recognized regulatory standards, Akadeum helps therapy developers minimize risk, accelerate qualification, and maintain compliance during scale-up.
Frequently Asked Questions
Akadeum operates under a rigorous Quality Management System aligned with ISO standards and the U.S. FDA’s Quality System Regulation (21 CFR Parts 11, 211, and 820). Our manufacturing processes are designed to meet or exceed expectations for ancillary materials used in cell and gene therapy manufacturing.
Yes. Akadeum has been successfully audited to U.S. and EU GMP standards, and manufactures in partnership with Pace Analytical, an FDA-registered facility. Our cleanroom operations, personnel training, equipment validation & calibration, and documentation practices meet the stringent conditions required for GMP manufacturing of microbubble-based products.
Absolutely. Akadeum’s GMP-grade reagents comply with USP <1043> Ancillary Materials for Cell, Gene, and Tissue-Engineered Products and ISO 20399:2022 Biotechnology – Ancillary Materials Present During the Production of Cellular Therapeutic Products and Gene Therapy Products. Each product is also evaluated in accordance with ISO 10993, Biological Evaluation of Medical Devices, and the ICH Q3D(R2) Guideline for Elemental Impurities.
Akadeum performs in-process and release testing in alignment with USP <71> sterility, USP <85> endotoxin, and ICH Q5A(R2) viral safety standards, as well as functional performance testing. Biocompatibility testing encompassed cytotoxicity, sensitization, hemolysis, intracutaneous reactivity, acute systemic toxicity, pyrogenicity, and thrombogenicity (with Thermo Dynabeads as predicate), with each testing plan and data report reviewed by certified toxicologists. Testing was completed by internationally recognized testing firms in alignment with ISO, ANSI, AAMI, and USP guidelines.
Many Akadeum kits are Animal-Origin Free (AOF) or sourced from qualified suppliers that meet ancillary material requirements and provide full transparency, including endotoxin levels and viral testing, reported via Certificate of Origin and Certificate of Analysis, or via a Letter of Authorization to cross-reference their Drug Master File (DMF).
Yes. Our Regulatory Support Team can provide Certificates of Analysis (CoA), Certificates of Origin (CoO, where applicable), Material Safety Data Sheets (MSDS/SDS), Product Information Files, and a Drug Master File (DMF) Letter of Authorization (LOA).
As a supplier of ancillary materials rather than a regulated biologic manufacturer, Akadeum is GMP-compliant but not FDA-certified for product licensure. This means our facilities, documentation, and quality systems meet GMP requirements, and we welcome partner audits to verify compliance for their specific workflows.
Requests for documentation, DMF Letter of Authorization, supplier questionnaires, or facility audits can be directed to our Regulatory Support Team or emailed to quality@akadeum.com. Our experts will coordinate document delivery and address product-specific regulatory questions.