Programs Protein Inducers

 

Sirona Biochem believes there is a strong commercial demand for the development of superior biological ingredients.

Our chemistry technology platform can be used for the development of enhanced inducers for recombinant protein production.  More specifically, inducers could be valuable in the production of insulin, human growth hormone, vaccines, interferon (anti-viral/bacterial/parasitic/tumor) and interleukin-2 (immune), and other recombinant protein produced by Escherichia coli (E. coli).

Inducers

Inducers are biological reagents that are used in laboratories for gene expression, an important process for the production of recombinant proteins.  Our product, IPGMim(TM), is in development for the production of recombinant protein by E. coli.  In the mid-eighties, biotechnology revolutionized insulin production when it was discovered that inserting an appropriate gene into a host organism (i.e. E. coli) could produce this “recombinant protein”.

We have applied our proprietary fluorination process with the aim of producing valuable inducers that initiate protein expression more efficiently.  It is our goal to develop enhanced inducers which are more stable and have less toxicity for the host organism and improved duration of gene expression.

  • Status & Milestones

Using gold standard tests, we are currently testing our inducer compounds and comparing them with similar inducers.  Our aim is to demonstrate that our molecules can successfully induce the expression of recombinant proteins in E. Coli and to compare the molecules’ efficiency, stability and protein yield against commercial products.

To date, studies have been conducted comparing Sirona Biochem’s inducer, IPGMim(TM), with IPTG, a leading commercially available inducer.  The studies have demonstrated that IPGMim(TM) produces more protein compared to IPTG at the same concentration.  IPGMim(TM) also induced synthesis of a soluble recombinant protein in E. coli for up to 24 hours.

A second study, performed independently by protein engineering firm PX’ Therapeutics further validated the induction performance of IPGMim(TM).  In the study conducted by PX’ Therapeutics, IPGMim(TM) induced synthesis of a recalcitrant protein of 13.6 kDa, known to be poorly expressed in E. coli.  In addition, IPGMim(TM) induced more protein than IPTG at the same concentration of 0.1 mM.  The kinetic study of induction at 37 degrees celsius showed that total production with IPGMim was 1.7 times and 2.9 times that of IPTG at 24 and 56 hours, respectively.

Further studies will be conducted with potential customers to further characterize the benefits of IPGMim(TM) over IPTG.

  • Market Opportunity

There are several recombinant proteins in clinical development for CNS disease, blood disorders, cardiovascular diseases, cancer and Type 1 & 2 diabetes.  Hematology, diabetes, endocrinology and oncology will be the most valuable therapeutic areas for the development of recombinant protein production.

The market for recombinant proteins is expected to significantly rise with sales forecasted to reach $75.8 billion in 2012, a 50% increase from 2007.

There are disadvantages of current inducers that are used in the production of proteins in E. Coli.  One is that it must be stored at -20°C.   This requires appropriate on-site storage at production facilities as well as appropriate transport.  A second disadvantage is that the product undergoes degradation under cell culture conditions of the bacteria.

There is a recognized need for more stable inducers for the production of proteins in E. Coli to improve protein expression and facilitate production.

Our inducer for protein production in E. Coli has been shown to be stable at ambient temperature and therefore can be stored and transported more economically than current inducers.

 

For any additional information please contact Aleksandra Kasikovic at akasikovic@sironabiochem.com.

Product Development

While carbohydrate-based molecules offer immense commercial potential, we are focusing on three programs at this time.