The extracellular matrix protein fibronectin is involved in a remarkably important set of functions that go beyond cell migration and adhesion, and encompasses disease control, as well as the structural integrity and functional properties of live tissues, and was recently shown to be important for its therapeutic effects in nanomedicine.
Fibronectin can be sourced from plasma or it can be cell-derived. As therapeutic systems which use fibronectin as an ECM component progress through the development pipeline, considerations about the sourcing and safety of those products for which fibronectin is part of the final formulation are becoming increasingly more important.
While removal and inactivation of adventitious and endogenous viruses is critical to the safety of the final product and is required by regulatory agencies, few changes have occurred to the manufacturing processes of plasma fibronectin to eliminate potential viral contamination from the source plasma over the years. By and large, plasma fibronectin is produced using animal-derived processes that have been in place for the past three decades.
Regulatory guidances provide a general framework for how demonstration of viral clearance should be performed, but they do not provide any comment about how to achieve such viral elimination. As far as fibronectin is concerned, no products have emerged on the market which address the inactivation of potential viruses from source plasma.
In order to combat this, we have introduced the first virus-inactivated fibronectin to the market recently. The product is fully validated and sourced from plasma which has been treated so as to inactivate any potential adventitious viruses.
The virus-inactivated fibronectin is available as a GMP product with a portfolio of documentation which includes batch records and well as prolonged stability data.
Functionally, virus-inactivated fibronectin is equivalent to the traditional non-virus-inactivated variant, with structural and functional homology – in other words, it is the same product. This is advantageous as it minimizes the characterization work that one would have to perform in order to introduce it into their process or switch from the regular fibronectin.
As the first of this kind on the market, the product has been verified in a number of studies and we are happy to discuss data with you.