GMP matters to Akadeum because our customers and their research matter. Customers can rest assured that Akadeum follows a standardized process that promotes a product manufactured under conditions and practices required by the GMP regulations. Customers will receive a product that has quality built into the design and manufacturing process at every step. Akadeum maintains a cleanroom appropriate for GMP manufacturing with equipment that is properly maintained and calibrated. Our employees are qualified and fully trained, and our processes are reliable and reproducible.
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.
Akadeum is committed to establishing and maintaining a quality system that is appropriate for all materials produced and developed within the company and ensures the system is appropriately controlled and meets the requirements of 21 CFR parts 211, 11, and 820.
Akadeum Life Sciences has aligned our processes and procedures to offer you a GMP Grade product. GMP regulations such as 21 CFR 820 ensure manufacturers establish and follow quality systems so that their products consistently meet applicable requirements and specifications.
At the center of GMP practices is the quality management system (QMS). Akadeum’s QMS includes procedures for reproducibility and continual improvement. Our internal system documents the standardized company practices for processes, procedures, and responsibilities to ensure product quality. The QMS outlines everything from manufacturing guidelines to handling customer complaints.
Combined with the advantages of the Alerion™ Microbubble Cell Separation System and BioRise® consumable, Akadeum GMP Grade products are ideal for use in your cell separation processes.
For all lot releases, the principles of GMP are strictly adhered to at Akadeum.
Akadeum is committed to establishing and maintaining a quality system that is appropriate for all products produced and developed within the company and ensures the system is appropriately controlled and meets the requirements of 21 CFR parts 211, 11, and 820.
Akadeum is compliant with USP <71> Sterility and USP <85> Bacterial Endotoxins via third-party testing of our GMP Grade products manufactured under 21 CFR 820, 210, and 211.
Our Clinical Ready Products are classified as blood path indirect, externally communicating, limited duration (<1 hour) contact, and thus have been tested per the following biocompatibility tests as determined in Table A.1: Biocompatibility Evaluation Endpoints, Use of International Standard ISO 10993-1 (Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process” FDA Guidance, SEP2023), reviewed by a certified toxicologist and have met specifications:
GMP compliance involves all practices in our manufacturing processes, including raw materials (and suppliers), methods, facilities and equipment, training, and controls used in the production, testing, and packing of our products. We perform risk assessments for all of our processes, identify potential risks, and adopt strategies to minimize their occurrence. High-risk areas that have been identified from gap analyses have been assessed, and plans implemented to ensure our partners and customers receive a safe and quality product.
Partnering with Sequoia Biotech Consulting, an experienced and renowned biotech regulatory and quality consulting group, and the expertise of our Quality Assurance Manager, Angela Pinkston, Akadeum readily achieved GMP compliance.
To be GMP certified, a company must be compliant, register with the FDA, and request the FDA to inspect the facilities that are producing a regulated product to certify that the facilities are actively meeting or exceeding GMP standards. As Akadeum is a supplier of ancillary materials and not a supplier of a regulated diagnostic or biologic itself, it is incumbent on the partner to seek approval for their workflow. Akadeum will hold ourselves to compliance with GMP standards and welcomes customer audits to support our partners in their goals. Please contact quality@akadeum.com for further assistance.
Akadeum has partnered with a national CDMO for the production of products in an FDA-registered facility. For more information, please contact us.
Akadeum products are for Research Use Only and are not intended for diagnostic or therapeutic purposes.