Periodic Reporting for period 1 - USONIPRO (Ultrasonic technology for bioprocess enhancement)
Reporting period: 2016-06-01 to 2016-10-31
The aim of the USONIPRO project is to develop and implement a technology, that uses sound wave propagation in order to increase the efficiency of the protein production. Companies that produce proteins in microbiological expression systems are looking for a solution that will increase the yield of their production, but currently there are only few commercially available technologies that solve that problem, and BBH Biotech Polska has found a unique solution to the problem with the use of sound waves.
The problem that the manufacturers need to solve is a limited efficiency of microbial expression systems due to the proteins that are stuck between membranes in the periplasmic space. According to protein producers this results in stopping the proteins from exiting cells and reduces product quantity.
As an answer to this problem, BBH Biotech Polska started developing its own technology. Its main idea is to use sound waves to deliver mechanic vibrations to microorganisms and “shake out” the proteins that are stuck in the periplasmic space. This kind of effect was observed during the tests performed on Trametes versicolor – a filamentous fungus. An enzymatic protein, that was stuck in the periplasmic space, was thrown out to the medium without destroying the cell and the enzymatic activity of the medium increased even by 100%. Thanks to these tests BBH Biotech Polska decided to approach the problem of the protein producers.
The device, which prototype was constructed by BBH Biotech Polska, uses multiple sound sources to deliver the vibrations to the medium. The sound sources are installed outside the fermenter. This very innovative feature will make the device easy to implement without serious changes to the existing production facilities and will enable a calibration of parameters individually tailored to the needs of the manufacturer.
Phase I of the SME Instrument was a very important step for the USONIPRO project to bring its technology from the laboratory into the market. Up to this point the BBH Biotech Polska had only a general idea of the market and regulations concerning the topic of recombinant proteins. After phase I the company has most of the necessary information needed for proceeding with the technology into phase II. With introduction of USONIPRO to the market, drug companies will be able to increase their production yield without significant increase in costs. This will allow them to redistribute the profits into developing new drugs and should cheapen the prices on those already existing on the market that involve microbial production such as eg. insulin.
Right now BBH Biotech Polska will focus on the new strategy as well as expanding their reach to other pharmaceutical companies to shorten the road to market that is still quite long. The company also plans to continue the cooperation with European Union in Horizon 2020 by submitting USONIPRO for phase 2 which will allow us to make the technology a fact in this decade.
The problem that the manufacturers need to solve is a limited efficiency of microbial expression systems due to the proteins that are stuck between membranes in the periplasmic space. According to protein producers this results in stopping the proteins from exiting cells and reduces product quantity.
As an answer to this problem, BBH Biotech Polska started developing its own technology. Its main idea is to use sound waves to deliver mechanic vibrations to microorganisms and “shake out” the proteins that are stuck in the periplasmic space. This kind of effect was observed during the tests performed on Trametes versicolor – a filamentous fungus. An enzymatic protein, that was stuck in the periplasmic space, was thrown out to the medium without destroying the cell and the enzymatic activity of the medium increased even by 100%. Thanks to these tests BBH Biotech Polska decided to approach the problem of the protein producers.
The device, which prototype was constructed by BBH Biotech Polska, uses multiple sound sources to deliver the vibrations to the medium. The sound sources are installed outside the fermenter. This very innovative feature will make the device easy to implement without serious changes to the existing production facilities and will enable a calibration of parameters individually tailored to the needs of the manufacturer.
Phase I of the SME Instrument was a very important step for the USONIPRO project to bring its technology from the laboratory into the market. Up to this point the BBH Biotech Polska had only a general idea of the market and regulations concerning the topic of recombinant proteins. After phase I the company has most of the necessary information needed for proceeding with the technology into phase II. With introduction of USONIPRO to the market, drug companies will be able to increase their production yield without significant increase in costs. This will allow them to redistribute the profits into developing new drugs and should cheapen the prices on those already existing on the market that involve microbial production such as eg. insulin.
Right now BBH Biotech Polska will focus on the new strategy as well as expanding their reach to other pharmaceutical companies to shorten the road to market that is still quite long. The company also plans to continue the cooperation with European Union in Horizon 2020 by submitting USONIPRO for phase 2 which will allow us to make the technology a fact in this decade.
During the 5 months of the project we acquired data regarding technical details of the technology, IP status of the technology and the idea, the structure and condition of the market, European legislation that must be taken into consideration and lastly, the company's vision of the future of this project.
Thanks to that data BBH Biotech Polska was able to create a reliable feasibility study that shows the necessary steps and actions that must be made for the USONIPRO technology to enter the market.
The first part of created feasibility shows the data and how it was acquired and was divided into five sections: technical feasibility, Intellectual Property rights protection, market analysis, regulatory aspects and business plan strategy. From those we can learn that USONIPRO will still need additional development to be fully profitable, and what changes must be made for it to work in accordance with EU and the US laws. Its Intellectual Property is in the hands of BBH Biotech Polska only, and there are no immediate threats to that matter. The feasibility study also points out the range and capacity of the market, as well as its problems, opportunities and possible threats. The technology was analysed with several market analysis methods such as SWOT, PEST and Porter Five Forces.
The final sales model and business strategy differs greatly from the one described in the proposal, since all of the data indicated that the chosen course of actions won't bring effects as they were anticipated. Section 2.5 of the feasibility study also fully describes the road ahead of this project and what needs to be done for the market entry which is expected in the first quarter of 2019.
In the second part of the study we described the outcomes of the information gathered during the SME Instrument Phase I and the conclusions of the actions.
In Section 3 we listed the final conclusions of the feasibility study as well as all the necessary actions that are needed for USONIPRO to succeed. The most important of those are finishing the development of the prototype and associating with a business partner who is a producer of biopharmaceuticals. Those two steps are crucial to develop and test the "ready to market product-service" in operational environment.
Thanks to this feasibility study the following conclusions can be made:
Technical issues - USONIPRO installation needs significant improvements in its several modules. These improvements will lead to a better stability and reliability of the installation.
Intellectual Property protection:
- there are 6 patents or patent applications that combine microbiological processes with soundwaves or ultrasounds;
- the current state of art shows that the technical solution which is the subject of USONIPRO possesses the novelty and inventive step required to gain a patent protection and does not interfere with any valid patents;
- we consider two main IP protection strategies, with the second strategy is regarded as the one more effective for USONIPRO: patent protection, protection by know-how.
Market:
- biopharmaceuticals market is a steady growing market with estimated increase around 8% annually;
- the total value of serviceable available market is estimated at 48,5 billion dollars;
- gaining 0,4% of serviceable obtainable market in first 3 to 5 years (estimated in SME Instrument Phase I proposal) will give our company a turnover high enough to dynamically develop this technology and additional projects;
- there are several companies that may be a valid competition;
- some companies, especially those that only manufacture proteins as CMO, will not be really interested in this technology;
- the current serviceable available market is beyond the reach of USONIPRO for at least next 10 years;
- the current situation on the market is favorable for BBH Biotech Polska and USONIPRO project, however there are some significant risks and threats that have to be taken into consideration.
Regulatory aspects:
- there are three EU directives concerning the technical side of USONIPRO;
- there are eight important documents concerning USONIPRO in terms of a device that takes part in pharmaceutical production;
- due to those harsh regulations our potential clients may, in some cases, have to forgo the whole procedure of introducing drug to market;
Business development:
- a precise business customer profile was made;
- two types of distribution channels are considered: direct (through sales representatives) and indirect;
- most of the fixed costs and necessary human resources needed for the technology were predicted, however, the data was not sufficient enough to create a sensible cash flow and to calculate the value of the minimum viable product;
- cash flow and the value of MVP are planned as a task for SME phase 2 in the near future;
- cooperation with a strategic partner is crucial to reach TRL 9.
Thanks to that data BBH Biotech Polska was able to create a reliable feasibility study that shows the necessary steps and actions that must be made for the USONIPRO technology to enter the market.
The first part of created feasibility shows the data and how it was acquired and was divided into five sections: technical feasibility, Intellectual Property rights protection, market analysis, regulatory aspects and business plan strategy. From those we can learn that USONIPRO will still need additional development to be fully profitable, and what changes must be made for it to work in accordance with EU and the US laws. Its Intellectual Property is in the hands of BBH Biotech Polska only, and there are no immediate threats to that matter. The feasibility study also points out the range and capacity of the market, as well as its problems, opportunities and possible threats. The technology was analysed with several market analysis methods such as SWOT, PEST and Porter Five Forces.
The final sales model and business strategy differs greatly from the one described in the proposal, since all of the data indicated that the chosen course of actions won't bring effects as they were anticipated. Section 2.5 of the feasibility study also fully describes the road ahead of this project and what needs to be done for the market entry which is expected in the first quarter of 2019.
In the second part of the study we described the outcomes of the information gathered during the SME Instrument Phase I and the conclusions of the actions.
In Section 3 we listed the final conclusions of the feasibility study as well as all the necessary actions that are needed for USONIPRO to succeed. The most important of those are finishing the development of the prototype and associating with a business partner who is a producer of biopharmaceuticals. Those two steps are crucial to develop and test the "ready to market product-service" in operational environment.
Thanks to this feasibility study the following conclusions can be made:
Technical issues - USONIPRO installation needs significant improvements in its several modules. These improvements will lead to a better stability and reliability of the installation.
Intellectual Property protection:
- there are 6 patents or patent applications that combine microbiological processes with soundwaves or ultrasounds;
- the current state of art shows that the technical solution which is the subject of USONIPRO possesses the novelty and inventive step required to gain a patent protection and does not interfere with any valid patents;
- we consider two main IP protection strategies, with the second strategy is regarded as the one more effective for USONIPRO: patent protection, protection by know-how.
Market:
- biopharmaceuticals market is a steady growing market with estimated increase around 8% annually;
- the total value of serviceable available market is estimated at 48,5 billion dollars;
- gaining 0,4% of serviceable obtainable market in first 3 to 5 years (estimated in SME Instrument Phase I proposal) will give our company a turnover high enough to dynamically develop this technology and additional projects;
- there are several companies that may be a valid competition;
- some companies, especially those that only manufacture proteins as CMO, will not be really interested in this technology;
- the current serviceable available market is beyond the reach of USONIPRO for at least next 10 years;
- the current situation on the market is favorable for BBH Biotech Polska and USONIPRO project, however there are some significant risks and threats that have to be taken into consideration.
Regulatory aspects:
- there are three EU directives concerning the technical side of USONIPRO;
- there are eight important documents concerning USONIPRO in terms of a device that takes part in pharmaceutical production;
- due to those harsh regulations our potential clients may, in some cases, have to forgo the whole procedure of introducing drug to market;
Business development:
- a precise business customer profile was made;
- two types of distribution channels are considered: direct (through sales representatives) and indirect;
- most of the fixed costs and necessary human resources needed for the technology were predicted, however, the data was not sufficient enough to create a sensible cash flow and to calculate the value of the minimum viable product;
- cash flow and the value of MVP are planned as a task for SME phase 2 in the near future;
- cooperation with a strategic partner is crucial to reach TRL 9.
Thanks to the acquired data BBH Biotech was able to reach two goals that were not foreseen in the proposal. Thanks to the support and experience of the coach provided by the European Commission we were able to determine several scenarios for USONIPRO development, including financial aspects, e.g. minimal price for a single installation, human resources and fixed costs related to the planned milestones on our road to market. We were also able to create a relevant customer profile for USONIPRO which also helped us find the second early adopter for this technology.