Quality

Why GMP Matters at Akadeum

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.

Quality Policy

Akadeum Life Sciences is committed to supplying the highest quality cell separation products and providing world-class support for our customers. Akadeum pledges continuous improvement and operates under an effective quality management system that meets regulatory standards and the establishment, review, and continued optimization of quality objectives aimed at excellence.

Our objective is to meet a high level of compliance through self-evaluations of standard operating procedures, comprehensive facility inspections, or audits, as well as good documentation practices.

Quality Objectives

1. Commitment to Quality
   Akadeum will fulfill the requirements of a quality management system and provide quality products and scientifically accurate information.
2. Commitment to Customers
   Akadeum will communicate effectively and honestly to earn customer trust and fulfill customer needs.
3. Continuous Improvement
   Akadeum regularly reviews quality metrics and trends to continuously optimize the quality management system and to provide the most accurate and up-to-date information for our products.

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.

What Do You Get When You Purchase an Akadeum GMP-Grade Product?

GMP Manufacturing and Benefits Explained

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.

Highlights of Akadeum’s GMP Grade Products

1. Stringent Documentation and Processes
   A key part of our QMS is documentation on how to perform each production step, from purchasing raw materials to packaging the final product. Besides detailed procedures, Akadeum’s QMS includes rigorous training to ensure laboratory personnel consistently follow the same production protocols. These documentation and training practices limit the sources of variability, resulting in high lot reproducibility, demonstrated in over hundreds of lots produced to date.
2. Traceability and Supplier Management
   An advantage of the extensive documentation present in our QMS is traceability. Each step in the manufacturing process requires documentation of who performed the work, what was done, and approval of the work. All components in the production of Akadeum products can be traced back to our suppliers, who have been qualified and audited for their commitment to quality. All products can be retraced from what the customer received to the raw materials used in the process. If a customer complaint is filed, the issue can be pinpointed by examining the associated documentation.
3. Well-defined standards, In Process Quality Checks (IPQC), and Quality Control Testing for Release
   To promote quality and process control, Akadeum’s trained personnel perform in-process quality control tests to ensure that established product requirements are met before the manufacturing process is completed. The function of in-process quality control is to monitor and, if necessary, adapt manufacturing processes to ensure that all products conform to specifications.

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.

Testing and Compliance With Standards for Clinical-Ready Ancillary Materials

1. Biocompatibility, Extractables and Leachables
   With assistance from certified toxicologists, Akadeum is engaged in biocompatibility studies in compliance with ISO 10993, with an industry-leading global provider of laboratory testing. Literature review and predicate research has achieved a consensus that silica-based nanomaterials are considered stable, biocompatible and nontoxic.

2. Compliance with Industry-Accepted Standards in Cell and Gene Therapy
   We have products compliant with USP standards <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. The Clinical Ready products are tested and evaluated per the protocols outlined ISO 10993 – Biological Evaluation of Medical Devices standards and are compliant with ICH Q3D(R2) Guideline for Elemental Impurities.

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:

• Cytotoxicity
• Intracutaneous Reactivity
• Acute Systemic Toxicity (IV and IP)
• Hemolysis
• Sensitization
• Material Mediated Pyrogenicity
• Thrombogenicity (with magnetics predicate)

Additional Information on Quality at Akadeum

Risk Assessment

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.

Quality and Regulatory Team of Experts

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.

GMP Grade Versus GMP Certification

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.