As human trials of potential COVID-19 vaccines begin, the Institution of Chemical Engineers (IChemE) is calling on governments and public health organisations to recognise the importance of a robust manufacturing process to enable vaccines to be widely available in as short a time as possible.
IChemE welcomes the significant progress achieved by research scientists in developing vaccines and congratulate the teams involved in working around the clock to find a preventative solution to control the pandemic.
Identifying the vaccine is of course crucial as the first stage of the process. However, it is equally as important to focus on the engineering required behind the scenes to be able to deliver billions of doses of vaccines to the wider global population. To achieve these volumes, the formulated vaccine developed in the laboratory needs to be scaled up which can be a complex process. The industrial-scale manufacturing process required to do this needs to be validated based on learnings from the processes and cleaning tests carried out during clinical trials, plus it needs to meet regulatory safety requirements. This requires a huge amount of scientific and engineering input along with further work on the sterile vial filling as well as the logistics of getting the product to the patient.
The desired outcome of the clinical trials, scale-up and validation work would be a manufacturing licence for the site and a marketing authorisation which allows the vaccine to be supplied to patients. The time and effort required to reach this stage should not be underestimated, nor the potential difficulty in finding suitable specialist industrial-scale manufacturing facilities since these are not widely available, nor quick to construct.
Working in partnership with the International Society for Pharmaceutical Engineering UK Affiliate (ISPE UK), IChemE has brought together an expert team of engineers with a vast amount of experience in the industrial manufacture of vaccines. The IChemE COVID-19 Response Team has been looking at the practical requirements for manufacturing a COVID-19 vaccine at the industrial scale required since the pandemic started, with a view to supporting the supply chain where required.
The IChemE/ISPE UK team rapidly identified that there is a shortage of manufacturing capacity for vaccines worldwide, particularly in the UK. Recognising this major obstacle in the supply chain, the IChemE team researched where there is spare capacity and is able to advise on solutions where companies or organisations do not have manufacturing facilities available.
Keith Plumb, IChemE Trustee and member of the IChemE COVID-19 Response Team, said:
“It is understandable that much emphasis is put on developing the vaccine itself, but it is vital to look beyond the excellent scientific work being carried out in laboratories to the practical engineering issues required for full scale manufacture. Our goal is to avoid the scenario of having proven vaccines available but nowhere to manufacture them at scale.”
The development, scale-up and manufacture of vaccines and medicines requires the expert knowledge of chemical engineers, biochemical engineers and process engineers. Responsible for transferring small scale research products to large scale manufacture, chemical engineers devise processes that consistently deliver consistent and pure products, design effective production systems and advise on optimum technologies to achieve efficient production.
If your company would like visibility of spare capacity in the supply chain, please contact the IChemE COVID-19 Response Team