Quality

Regulatory and Quality Systems at Akadeum

Akadeum manufactures and is compliant with standards for ancillary materials for use in cell and gene therapy. As the first negative selection GMP company, Akadeum has years of experience producing GMP microbubble-based products and has been successfully audited to US and EU GMP standards.

GMP matters to Akadeum because our customers, their research and development of life-changing therapeutics and the patients their work helps 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 from product realization to commercialization, including regulatory. Akadeum maintains a cleanroom appropriate for GMP manufacturing with equipment that is properly maintained and calibrated and has paired with Pace Analytical for manufacturing of products in an FDA-registered facility. Our employees are qualified and fully trained, and our processes are reliable and reproducible.

Quality Policy

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.  

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.

Quality and Regulatory Team of Experts

Partnering with Dark Horse Consulting, an experienced and renowned cell and gene therapy regulatory consulting group, Akadeum has completed a drug master file to support the BACS Streptavidin Microbubbles and associated protocol for use. Akadeum is continuing the Dark Horse Consulting engagement for any customers seeking regulatory support in the use of Akadeum’s products.

Akadeum’s GMP compliance achievement was supported by Sequoia Biotech Consulting and is managed by the expertise of our Quality Assurance Manager, Angela Pinkston.

Attributes of Akadeum’s Quality Management System

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 – , well-established leaders in the life sciences 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, including sterility checks, 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:

• Sterility testing per USP <71>
• Endotoxin testing per USP <85>
• Viral testing of antibodies per ICH Q5A(R2) guidelines
• Functional testing

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.

Testing and Compliance With Standards for Ancillary Materials in Cell & Gene Therapy

1. Biocompatibility, Extractables and Leachables
   With assistance from certified toxicologists, Akadeum has completed 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
   Akadeum’s GMP products are 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 GMP 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.

Akadeum’s GMP 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 Management Program

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. In compliance with ISO 13485 and ISO 14971, Akadeum performs risk assessments for all processes, products and systems, identify potential risks, and adopt strategies to mitigate occurrence.

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 products are for Research Use Only. It is up to the sponsor to determine fit for use.