In March 2015, CPI secured a multi-million-pound investment via the Government’s Advanced Manufacturing Supply Chain Initiative (AMSCI) to support the development and manufacture of novel biologic treatments. This case study gives an overview of what the project will entail and the impact it will have on the industry.
The biopharmaceutical drug development process is lengthy, expensive and fraught with risk. Typically, it takes many years to get a drug from discovery to the market and costs hundreds of millions of dollars. Failures occur for many reasons; from lack of efficacy in the clinic and patient safety issues to development and manufacturing issues which can render a drug uneconomic. Whilst the reasons for failure are often beyond our control, given the right technologies many issues could at least be predicted allowing early decisions to be taken on which drug candidates to progress and what manufacturing issues will need to be solved.
The AMSCI funded project seeks to demonstrate an improved pathway for the development of biopharmaceuticals. Cutting edge predictive technologies will be applied to a panel of therapeutically relevant drug candidates and the results compared to experimental data on the same molecules. With this knowledge it will be possible to devise a development route that enables early decisions to be taken on the suitability of drug candidates, to maximise the chances of clinical and manufacturing success.
Enabling decisions to be taken earlier in the development cycle will have a massive positive impact on the economics of drug development, reducing the number of candidates that fail at a late stage when significant amounts of money have been spent on them. Resources will therefore be able to be directed to the advancement of the most promising molecules. The project is a large scale collaboration involving two world class multinational biopharmaceutical companies but also involving SME’s, midsized technology companies and academic partners.
The project will be led and managed by CPI who are also providing some key scientific resources and access to their facilities to enable the project to be conducted in a truly collaborative manner. The project outputs will be implemented by the partners in various ways but overall the tools, techniques and workflows that result will have a major positive impact on the biopharmaceutical industry, both in the UK and beyond.