The White Paper discusses the important aspects of analytical approaches in ensuring raw material quality, why it might be necessary to consider partnering with an organisation that has the requisite knowledge and the key points to contemplate when forming this partnership to ensure a smooth process.
Developing an understanding of the analytical landscape for testing complex biological raw materials in advanced therapy medicinal products: a CRO perspective
Unlike antibody-based products which are generally single, highly purified proteins, ATMPs are complex products. Production of these involves the use of technologies specifically designed or adapted for producing ATMPs and as a result, the regulatory expectations for these products have increased to match the additional complexities involved. An important aspect of the manufacture of cell and gene therapy products is the role raw materials play and the controls required to ensure consistent product quality and, most crucially, patient safety. Important aspects of analytical approaches to ensure raw material quality will be discussed in this White Paper.
Advanced therapy medicinal products (ATMPs) are medicines for human use that are based on genes, tissues or cells and can generally be classified into three distinct categories: gene therapy, somatic-cell therapy and tissue-engineered medicines. All ATMPs function by manipulating the target biological system to treat the disease.
An important aspect of the manufacture of cell and gene therapy products is the role of raw materials and the controls required to ensure consistent product quality and, ultimately, patient safety. The fundamentals of Good Manufacturing Practices (GMP) still apply. Importantly, within the EU the terms ‘starting materials’ and ‘raw materials’ must also be distinguished. Starting materials (SM) cover the human cells and tissues used in the final product, whereas raw materials are defined within EU Directive 2001/83/ EC1.
Not all companies have the ability or resource to perform the required raw materials testing. In such instances, partnerships with CROs are considered, and the choice may be dictated by the regulatory status (EMA/FDA inspected and approved), experience and knowledge around the product area. The CRO must have an understanding of what may be required and can help to guide clients through the testing regime. This paper will not cover all of the aspects that are fundamental to ensure the quality of the product is as required but does consider the points that are important when you are forming partnerships with a CRO to perform aspects of the raw materials testing.
Originally published by Bio Insights. Click here to read the full White Paper.
Cell & Gene Therapy Testing Service
Visit our Cell & Gene Therapy Testing page today and find out how we can become your trusted partner for analytical testing in the development of ATMP's or you can contact us here.