According to Dr. Paul Quigley, head of API development and bioanalytical services at Arcinova, “Arcinova felt that the current Innovate UK funding round for the development of new medicines manufacturing technology was an ideal opportunity to enhance our technological capabilities ... The initial focus was on the development of new continuous manufacturing technologies, and this was an area of particular importance to Arcinova and an area where the University of Nottingham has particular strengths. Our previous successful track record of collaboration, allied to the skill sets of the Nottingham and Arcinova teams in the area of continuous processing technology development, made this collaboration a natural evolution of the current relationship.”

 

The project, which will span a three-year period, will be undertaken in collaboration with a team led by Prof. Mike George, with Prof. Pete Licence and Prof. Sir Martyn Poliakoff at the University of Nottingham. The aim of the project is to develop a continuous, flexible modular manufacturing technology platform which will enable Arcinova to handle increasingly complex chemistries with more discrete manufacturing steps.

 

“In response to the development of new and more targeted pharmaceutical treatments, small-molecule drug substances are becoming more complex in nature, more potent and, as a consequence, the drug substance requirements for a candidate drug—both through the clinical development phase and at commercial launch—has reduced significantly,” Quigley notes.

 

“Our vision for this project is the development of a continuous, flexible modular manufacturing technology platform which will enable Arcinova to meet this technology need and to be a leading player in the development, scale-up and manufacture of new small-molecule drugs. Initially, a number of key technology areas will be chosen for development,” continues Quigley. “These areas will be chosen on the basis of expected technical need from Arcinova and on the basis of demonstrated expertise from the academic partner (University of Nottingham).”

 

“My colleagues and I at Nottingham are firmly convinced that flow chemistry can transform chemical manufacture in the U.K., and this partnership with Arcinova is an opportunity to turn our vision into reality,” added George, a professor of chemistry at the University of Nottingham.

 

The developed continuous modular manufacturing technology reportedly will be easily scalable, with a reduced manufacturing footprint when compared to more traditional batch reactor approaches. The developed technologies will enable Arcinova to enhance manufacturing capacity and minimize inventories for highly reactive hazardous processes whereas for a batch process the reaction scale would be severely constrained. The developed flexible modular manufacturing technology platform will enhance Arcinova’s existing infrastructure in GMP and non-GMP assets, which include five-liter and 20-liter GMP vessel streams, and builds on its current capabilities in continuous processing technology.

 

“The growth in novel, increasingly potent and technically complex small molecules as new candidate drug substances necessitates a radical rethink in terms of the technology required to generate them. Currently the need is for technologies which will provide the capability to manufacture drug substances in small volume, with the facility of rapid changeover of production, with high process intensity and product yield, generating high purity materials and with the ability to handle potentially hazardous reagent conditions. Additional requirements would include the need for improved process economics when compared to traditional batch processing conditions, and the ability to minimize process solvents, reagents and catalysts as further drivers,” Quigley tells DDNews.

 

“Continuous processing technologies offer a solution to this unmet need, yet the technology is still evolving and in many areas (oxidation, thermal processing [high and low] and in solvent reuse) the technologies available are not, as yet, scalable,” he notes. “Arcinova in particular has a need for a technology which could offer the capability to satisfy long-term demand for new chemical entities as drug substances on an existing site footprint without the need to use large chemical reactors, with low inventories and with the ability to offer world-class chemical processing technologies that would differentiate us from the global competitor base and enhance our business growth prospects.”

 

When asked how the project has been since the announcement of the grant in April, Quigley says, “The project is going well, with the University recruitment phase in an advanced state. We have good project management discipline in place and regularized meetings to ensure that the project outputs are well managed and metricated. Our intention is to rapidly apply the developed manufacturing technologies to real case projects which can rapidly enhance Arcinova’s technological competitiveness.”