The world has been plunged into an unprecedented public health and economic crisis. In order to return to normality and begin to recover, the race is on to find an effective vaccine against Covid-19 and manufacture the millions of doses required to build immunity, a process that can typically take more than a decade.
Thankfully, the UK is exceptionally well placed – with established tools, technologies and expertise – to rise to this challenge, as Lucy Foley, Director of Biologics at CPI, explains.
Over the past 15 years, the UK has been cementing its position as a global leader in biopharmaceutical research and next0generation manufacturing.
This position is supported by top universities with experience of novel vaccine technology, as well as organisations including CPI, the Cell and Gene Therapy Catapult, and the Vaccines Manufacturing Innovation Centre.
All the pieces are in place to fast-track an effective vaccine which can provide much needed protection against Covid-19. Now, the challenge is to help these different organisations, from across the supply chain, to work together as effectively and efficiently as possible.
CPI’s cutting-edge National Biologics Manufacturing Centre in Darlington carries out bioprocessing projects that aren’t currently possible within industry. Image: CPI
Strong collaborations are key to ensuring that when a vaccine becomes available, it can be rapidly rolled out to market. This will require a wide breadth of skills and expertise, with input from scientists, engineers and clinicians.
The BioIndustries Association (BIA)-led vaccine manufacturing group has been established to bring together the necessary expertise from academia, industry and supporting organisations.
The group will focus on developing processes for the scale-up and manufacture of the two most promising vaccine candidates being developed in the UK – Imperial College London’s saRNA (self-amplifying RNA) vaccine candidate, and Oxford University’s adenovirus vaccine candidate.
It is working closely alongside the government’s Vaccine Taskforce and reports directly to the UK’s Chief Scientific Advisor, Sir Patrick Vallance.
This article first appeared in the June issue of The Manufacturer magazine. Click here to subscribe
The saRNA vaccine candidate being developed at Imperial College London has several characteristics that make it an attractive option in the fight against Covid-19.
Firstly, like monoclonal antibodies and the seasonal influenza vaccine, this vaccine candidate is being developed using a platform-based approach. Vaccine platform technology lends itself relatively easy to scale-up, delivering significant benefits in terms of speed to market.
Secondly, the vaccine is self-amplifying within the human body, which means that the dose required to provide immunity will be at least an order of magnitude smaller compared to other mRNA vaccines.
Finally, the vaccine is produced via chemical synthesis rather than being expressed in cell cultures, which are notoriously difficult to work with and scale-up.
This allows mRNA and saRNA vaccines to be produced on a much shorter timescale than traditional vaccines, generating millions of doses from one manufacturing process.
All of these traits ensure that a vaccine could be available immediately following successful clinical trials.
However, while Imperial College has a wealth of experience in working with saRNA vaccines on a small scale, there are currently no mRNA or saRNA vaccines on the market, and as a result there is relatively little experience with large-scale manufacturing of this type of therapy.
Bridging academia and industry
CPI, a founding member of the High Value Manufacturing Catapult (HVMC), acts as a bridge between academia and industry and is currently helping to lead this saRNA vaccine candidate workstream.
This work includes evaluating the process of scale-up and development of the mRNA vaccine platform technology. Brought together by the BIA-led vaccine manufacturing group, this collaboration will focus its efforts on building the capability to manufacture the millions of doses of the vaccine as soon as it is found to be safe and effective.
The work would be carried out in-house at CPI’s National Biologics Manufacturing Centre in Darlington, UK, established to carry out bioprocessing projects that aren’t currently possible within industry.
The biologics facility provides state-of-the-art equipment and multi-disciplinary teams who are used to working together, as well as with many different project partners. The Centre has extensive experience in dealing with novel, untested and challenging biotherapeutics.
It is staffed with a 50/50 mix of personnel from a scientific background and those from an engineering background; both mind-sets are vital for delivering a feasible manufacturing process for this new vaccine candidate.
CPI’s National Biologics Manufacturing Centre is staffed with a 50/50 mix of scientists and engineers. Image: CPI
While this Centre was built to be very similar to a biopharmaceutical facility, as a traditional R&D facility upgrades would have to be made to manufacture vaccines for human use.
To facilitate the rapid manufacture of this vaccine at scale, CPI is now seeking GMP accreditation for the Centre, which could be acquired relatively quickly thanks to this forward thinking in facility design.
The saRNA vaccine candidate entered trials in June, and CPI has already started to transfer the manufacturing process to its facilities. Intense work will be carried out on the scale-up of manufacturing as the vaccine candidate progresses further through clinical development.
This should greatly minimise the delay between vaccine approval and the manufacture of the millions of doses required to immunise the UK population.
A mass vaccination programme would have a tremendous and immediate impact on society, easing strain on healthcare services and allowing a return to normality.
However, the development of a successful mRNA vaccine platform in particular will have more far-reaching effects, providing scientists with a foundation to create mRNA vaccines against many diseases with unmet clinical needs in the future.