Fibroblast Growth Factor’s remarkable biological function, now newly formulated for cell therapy use

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The fibroblast growth factor (FGF) family counts 22 characterized members – since their discovery over 6 decades ago, the FGF proteins have been linked to essential roles which include cell proliferation, differentiation and apoptosis, embryonic development and differentiation, neuron differentiation, survival and regeneration, normal skeleton development, and the proliferation of various types of cells.

Other roles include the regulation of vitamin D metabolism and osteogenesis and post-natal bone mineralization by osteoblasts, with new evidence supporting their regulation of appetite control.

Just recently, more significant implications about FGF in tissue regeneration were reported. The lab of Dr. Atsushi Kawakami at the Tokyo Institute of Technology published, in the journal Development, their observations on the mechanism by which FGF signaling is involved in tissue regeneration. They studied this by investigating the regeneration of damaged fins in zebrafish, and identified FGF-20a and FGF-3/10a as major FGF ligands in wound epidermis and blastemas, respectively, important for the regeneration process. Because FGF-20 and FGF-3 are present in all vertebrate species, this study may uncover potential cues to how tissue regeneration is regulated in mammals, as well as humans.

Clinically, studies such as the above one, as well as discoveries made over the past few decades have resulted in an increasing focus from the part of pharmaceutical and cell therapy companies developing biologics to target FGF receptors that are implicated in important therapeutic functions via their signaling and regenerative roles. Companies such as Boehringer Ingelheim are involved in clinical studies for new biologics targeting, among others, signal transduction pathways regulated by FGF.

And the market has responded – FGF is ubiquitous and readily available. It can be found stable, functional, and lyophilized, often with excipients to improve its stability.

However, as the clinical development of biologics advances – and such advances are progressing rather rapidly – so should the industry’s response to the shifting needs of clinical developers. Such needs include a more thorough consideration on safety, sterility and cell therapy use.

While Akron has been a strong, leading supplier of multiple FGF proteins for many years, we have now gone one step further and developed a formulation of FGF which directly addresses the use of the protein in cell therapy settings.

Our new FGF is a ready-to-use, fully-formulated and reconstituted, liquid-phase FGF basic. Having formulated FGF in liquid form makes the protein amenable to single use scenarios and eliminates the need for cumbersome reconstitution. In doing so, we have addressed common contamination issues that arise during handling of the powder. Moreover, sterility, critical in cell therapy processes, is maintained in a single-use configuration.

Filled to multiple sizes, the new liquid FGF is a revolutionary solution that removes ambiguity during use, being formulated to exact activity specifications.

As a first step to showing you how this new FGF can simplify and improve your workflow, contact us to discuss – we would be happy to learn about your application.

 

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