As human trials of potential COVID-19 vaccines begin, the Institution of Chemical Engineers (IChemE) calls on governments and public health organizations to recognize the importance of a robust manufacturing process to enable vaccines to be widely available in as short a time as possible. IChemE says it welcomes the significant progress achieved by research scientists in developing vaccines and congratulates the teams involved in working around the clock to find a preventative solution to control the pandemic.
Identifying the vaccine is crucial as the first stage of the process. However, it is equally as important to focus on the engineering required behind the scenes to deliver billions of doses of vaccines to the wider global population, notes IChemE. To achieve these volumes, the formulated vaccine developed in the laboratory needs to be scaled up. The industrial-scale manufacturing process required needs to be validated based on learnings from the processes and cleaning tests carried out during clinical trials. It also 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, according to IChemE.
The desired outcome of the clinical trials, scale-up and validation work would be a manufacturing license for the site and a marketing authorization that 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, says IChemE.
Working in partnership with the International Society for Pharmaceutical Engineering UK Affiliate (ISPE UK), IChemE brings 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. Recognizing 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 organizations do not have manufacturing facilities available.
“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,” says Keith Plumb, IChemE trustee and member of the IChemE COVID-19 Response. “Our goal is to avoid the scenario of having proven vaccines available but nowhere to manufacture them at scale.”
Companies with spare capacity in the supply chain should contact the IChemE COVID-19 Response Team at [email protected].
For more information, visit: www.icheme.org
