Quality

Why GMP Matters at Akadeum

GMP matters to Akadeum because our customers and their research matters. Customers can rest assured that with Akadeum following a standardized process that promotes a product that was manufactured under conditions and practices required by the GMP regulations that they will receive a product that has quality built into the design and manufacturing process at every step. Akadeum maintains a GMP compliant cleanroom, our equipment 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 products and providing world-class customer support for our customers. Akadeum pledges continuous improvement and operation for our products 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 GMP-related documentation.

Quality Objectives

1. Commitment to Quality
Akadeum will fulfill the requirements of the quality management system and provide scientifically accurate products.

2. Commitment to Customers
Akadeum will communicate effectively, efficiently, and honestly to earn customer trust and fulfill customer needs.

3. Continuous Improvement
Akadeum will regularly review quality metrics and trends to continuously optimize the quality management system and provide the most accurate and up-to-date data for our products.

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.

 

What do you get when you purchase an Akadeum GMP-compliant product?

GMP Manufacturing and benefits explained

Akadeum Life Sciences has aligned their processes and procedures to offer you a GMP-compliant product.  What does that mean? GMP regulations such as 21 CFR 820 make sure manufacturers establish and follow quality systems to help ensure that their products consistently meet applicable requirements and specifications.

Fundamentally at the center of GMPs 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. It outlines everything from manufacturing guidelines to handling customer complaints.

Combined with the advantages of the human cell-expressed system, Akadeum GMP-compliant products are ideal for use in your separation processes.

Featured Highlights of GMP-Compliant Akadeum Products

1. Stringent Documentation and Processes: Lot Consistency
A key part of our QMS is documentation on how to perform each step, from buying raw materials to packaging the final product. Besides detailed procedures, Akadeum’s QMS outlines 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
An advantage of the extensive documentation in the QMS is traceability. Each step in the manufacturing process requires documentation of who performed the work, what was done and an approval of the work. All components in the production of Akadeum products can be traced back to our suppliers, who are also committed to quality. All products can be traced back from what the customer received to the raw material the process started with. If a customer files a complaint, the issue can be pinpointed by examining the 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 quality is met before the manufacturing process is completed. The function of in-process quality control is monitoring and if necessary, adaptation of the manufacturing processes to ensure that the product conforms to its specifications.

For all lot releases, the principles of GMP are strictly adhered to at Akadeum.

Furthermore, Akadeum can provide our consumers with documentation that states that our products are wholly obtained, produced, manufactured or processed in the United States.

 

Compliance with Industry-Accepted Standards

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.

By the end of the year, we will also be compliant with USP standards <1043> Ancillary Materials for Cell, Gene and Tissue Engineered Products, USP <71> Sterility and USP <85> Bacterial Endotoxins via third-party testing.

 

The Journey from GMP-Compliance to GMP-Certified

Akadeum understands that it is imperative to be both prepared and understand what is required for GMP certification. Akadeum is taking into account the following steps and considerations to get ready for certification should this be a requirement of our partners:

Building A GMP Team of Experts

Partnering with Sequoia Consulting Group, an experienced and renowned biotech regulatory and quality consulting group, and the onboarding of our Quality Assurance Manager, Angela Little, has placed Akadeum on the fast track for certification should a partner require it. A gap assessment has been completed and additional recommendations to ensure Akadeum is ready for certification are currently being implemented.

Risk Assessment

GMP involves all of the practices in the manufacturing of our products; from the raw materials, methods, facilities and equipment, training and controls used in manufacturing, processing, and packing of our products. GMP requires that we perform risk assessments of all of our processes, identify areas that contain potential risks, and adopt strategies to minimize their occurrence.  High risk areas that Akadeum has identified from the gap analysis have been assessed and a plan implemented to ensure our partners get a safe and quality product.

Biocompatibility, Extractables and Leachables

With Sequoia’s assistance, Akadeum is actively planning biocompatibility studies in compliance with ISO 10993. Initial literature and predicate research achieves a consensus that silica-based nanomaterials are considered stable, biocompatible and nontoxic.

GMP Certified

To be cGMP certified, a company must be compliant, register with the FDA and request the FDA to inspect the facilities and certify that the facilities are actively meeting or exceeding cGMP 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 the GMP standard, welcome audits by our partners and can support the partner in their goals, please contact quality@akadeum.com to discuss further.

Akadeum products are for Research Use Only and are not intended for diagnostic or therapeutic purposes.

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