Report
Teaser, summary, work performed and final results
Periodic Reporting for period 1 - SpectraHow (SpectraHow. Smart Raman sensor to speed up biopharma manufacture)
Teaser
To bring a new drug to the market, biopharma companies spend 13 years where 18 months are dedicated to the drug process development, investing an average of € 3 Billion. Once they have the approval, pharmaceutical production costs €66 Billion including costs of failure...
Summary
To bring a new drug to the market, biopharma companies spend 13 years where 18 months are dedicated to the drug process development, investing an average of € 3 Billion. Once they have the approval, pharmaceutical production costs €66 Billion including costs of failure runs (currently up to 5%). Biopharma companies face an increased pressure for cheaper process development, faster time to market as a 6 months delay in process development could cost $100 million per drug.
Through this project we are going to assess the technical commercial and financial feasibility of SpectraHow, our data analysis software for drug processing monitoring.
SpectraHow will be a user-friendly and a plug-and-play solution to predict important variables during the drug processing such as concentration of viable cells and glucose as well as important product characteristics for process optimization and quality assurance such as product and impurity concentrations using one automated sensor. For each variable to be predicted SpectraHow finds, with advanced non-linear algorithms, the optimal modelling solution amongst millions of possibilities and provides a real-time basis for process monitoring and control. SpectraHow advantages are a reduction of the time to create a reliable prediction of the drug processing (reducing the need of 1200h per year for an expert) and improvement of the predictive accuracy (by up to 80%) and robustness (by up to 50%).
Work performed
• We have identified and described the technical requirements of SpectraHow and the development steps to: fine tune our algorithms, define IT integration, Good Manufacturing Practices (GMP) certification, and NIR/MIR diversification. As a result of our analysis during the EIC accelerator project we will focus SpectraHow developments on algorithm consolidation and the IT platform development.
• We have designed a roadmap to develop, and test SpectraHow, identifying project development risks (mainly focused on the alignment with client’s needs) and proposed mitigation measures (AGILE methodology)
• We have performed a survey among our current clients to assess their experience and expectations of process Raman analyser software.
• We developed a market analysis and found that biopharma market is an attractive niche where SpectraHow has almost no competitors. Moreover, our expansion to the pharma market is also feasible.
• We have identified market barriers and commercial risks and designed a mitigation strategy accordingly.
• As a result of our market analysis, we have found that our current distributor partner holds the biggest share in the process Raman analyser manufacture market. To further expand our market coverage, we have identified Bioreactor suppliers, flow meters manufacturers and SCADA providers as possible partners.
• As biopharma is a small market niche, we have defined our dissemination plan to have high impact via specialised conferences.
• We developed an FTO analysis that confirmed the possibility to commercialise SpectraHow in our target countries and determined the best action plan in order to protect SpectraHow’s related IP.
• We have assessed the investment/resources needed for the development and market launch of SpectraHow; and confirmed our current pricing strategy and our preliminary 5-year post-project financial forecast
Final results
We have already developed SpectraHow’s core algorithms to build the predictive models from the spectral data. Our algorithmic toolbox has been already tested for different drug processes with leader pharma companies.
At the end of the SpectraHow phase 2 project, we will launch into the market a software covering 70% of the most used drug processes in the biopharma industry. Through a user-friendly interface we will reduce 1200 hours of work from an expert and reduce the deployment time to only 1 day (plug- and –play solution). We will be present in Europe, and USA since the beginning of the project involving leading biopharma companies from these markets into our pilot testing phase. We will carry out our dissemination and communication strategy presenting SpectraHow in specialised conferences, webinars and our own annual event on big data during the next two years.
SpectraHow supports Smart Manufacturing and Industry 4.0 Initiatives (key goal for biopharma industry during the next 10 years). Our software is aligned with European policy to foster sustainable economic development as the European pharma industry today employs more than 750,000 people and generates 1.8 million indirect employment. In addition, as SpectraHow enables faster time to market and reduced development costs, it might drive reductions in future drug’s prices contributing to United Nations’ Sustainable Development Goals (SDGs) especially SDG-3 - the high cost of health care is a burden on individual patients, their families, and society as a whole.
Website & more info
More info: https://www.datahow.ch.