Regulatory Situation at a Glance
Cell separation reagents like collagenase used during the manufacture of cell therapy are defined by regulatory agencies as ancillary materials (AMs). Since an AM comes in direct contact with cells destined for clinical administration, the quality of the AM can affect the safety, potency and purity of the cell product. Currently, no AM-specific regulations exist in worldwide regulatory frameworks. Although some organizations provide a framework for strategies to control AMs, they do not precisely define the regulatory or quality requirements for AMs.
Nordmark Pharma applies German pharmaceutical standards to the manufacturing of our products and complies with GMP requirements. We ensure proper design, monitoring and control of the manufacturing process and provide safe products for use in clinical applications. The FDA and many other regulatory agencies have certified our manufacturing process.
Our products are being used in clinical trials in many countries worldwide and local regulatory agencies approved Nordmark’s enzymes for the isolation of different cell types included in the Clinical Islet Transplantation trial (IND# BB-IND 9336). Currently, Nordmark enzymes are involved in more than 20 % of the clinical trials in the US dealing with cell therapy and tissue engineering products.
Our Regulatory Support for You
For some products we have already submitted a Drug Master File (DMF) to the US Food and Drug Administration (FDA) which users can then reference in their regulatory submissions. For such cases, we issue a Letter of Authorization to the customer, who will hand it over to the FDA for DMF access.
"…. it [the DMF] makes my job much easier and is a win-win for all parties. I could not comment on who I have advised and cannot promote your products, but I can and will inform those consulting with the FDA on pre-clinical studies that „translational collagenase“ with a DMF is available."
With our outstanding regulatory expertise, we are able to guide you through your registration process.
On request, many documents are available:
- Batch records
- Certificate of Analysis
- Validation reports
- Stability according to ICH guidelines
- Qualification documents
- TSE-CEP certificates
- GMP certificates
- and many more...