River Stone Biotech has developed a first-in-kind platform combining synthetic biology with improved chemistry processes to solve these key industry challenges.

How Does It Work?

River Stone Biotech has leveraged the power of synthetic biology to simplify the production of alkaloid molecules, initially: Buprenorphine, Naloxone and Naltrexone. Whereas current industry standards utilize a complex chemistry process to generate these products, River Stone Biotech has discovered a synthetic pathway that uses a novel intermediate to remove several synthetic steps, producing APIs faster and cheaper.

Our state-of-the-art patented technology permits:

  • Product Safety and Quality.
  • Removal of 2 highly toxic steps.
  • Improved environmental footprint.
  • Substantial cost reductions.
  • Higher yields.

Solving Environmental Challenges

The synthesis of opioid alkaloids such as Buprenorphine, Naloxone and Naltrexone incorporates a key chemical transformation known as an N-demethylation. The classical and often employed method of performing the N-demethylation requires the highly toxic compound cyanogen bromide. The by-product of this reaction is another toxic substance, hydrogen cyanide. This method leaves staff at risk of exposure to dangerous chemicals and requires significant disposal operations. While newer chemical N-demethylations have been developed, published reviews have identified the construction of transgenic organisms that would overexpress an enzyme responsible for the N-demethylation 1. This method will be superior to all other approaches, as the demethylation could be performed by fermentation in aqueous medium.

River Stone Biotech has realized this safer, superior approach that uses fermentation to perform the demethylation. This method does not involve toxic reagents or by-products, eliminating the risk of exposure to dangerous chemicals whilst slashing costs and the environmental impact associated with disposal of harmful compounds. Not only this, it also reduces the number of synthetic steps to the product, resulting in a leaner process that reduces the environmental footprint.

River Stone Biotech has been the first to develop and patent in this area, developing a cleaner and safer process that is more efficient for large-scale production. This puts River Stone Biotech at the forefront of producing APIs with a reduced environmental footprint.

Leveraging Our Platform

River Stone Biotech has established a strong IP portfolio. The platform can be harnessed to realize other product opportunities, offering revolutionary production methods across a variety of alkaloid compounds.

Our scientists are constantly innovating to evolve chemistry, microbiology and fermentation processes.

River Stone Biotech has a full suite of synthetic biology capabilities, including informatics, powerful gene integration tools, proprietary component libraries, diverse screening platforms, analytical systems biology, analytical chemistry, enzyme design & evolution, strain optimization and evolution, fermentation scale-up, downstream processing and quality control.

1. Hudlicky, T., 2015. Recent advances in process development for opiate-derived pharmaceutical agents. Canadian Journal of Chemistry, 93(5), pp.492-501.