Over the last year, pharmaceutical companies have made a significant global effort to develop a vaccine to combat Covid-19. Now with the announcement by Pfizer and BioNTech that a vaccine is close to being available and other vaccine developers also in the final stages, manufacturers need to ramp up production to satisfy the enormous demand. This is something not seen since the second world war when the first mass-scale production of antibiotics happened.
To meet this expected demand, pharmaceutical companies have attempted to shorten production time by securing funding in advance (in the form of pre-purchase agreements). This has enabled them to take a significant commercial risk by manufacturing vaccines at a large scale before clinical trials have been completed and evaluated. As a result, substantial stockpiles of new vaccines to be accumulated ready for use once approved.
However, this strategy on its own has not been sufficient to produce the billions of doses required. So, both small and larger pharmaceutical companies have also relied on outsourcing to contract manufacturing organisations (CMOs). The smaller companies lack manufacturing capabilities, so they have no choice but to use external suppliers, and even the largest companies require extra resources to produce the billions of doses needed should their vaccine be approved. Vaccine sponsors as large as AstraZeneca and Johnson & Johnson are using CMOs for their pipeline vaccines.
The task of transferring an approved vaccine recipe to numerous production facilities worldwide and ensuring that every batch has the same strength of the active ingredients, quality, and purity is not to be underestimated. This requires precise recipe management. Recipe management prescribes the actions, machine parameters, and documentation required to convert input materials into high-quality medicines.
Quite often, this is a very slow process. Having had dispersed, often paper-based documentation approved by all the stakeholders, an operator may have to handle confirmed machine parameters manually on each production machine. And a single production machine may require up to several hundred parameters.
The whole process must be repeated on every production line, so this manual and repetitive work is inherently error-prone. Each deviation results in lost production time and even the destruction of an entire batch.
The most efficient and risk-free way to do this is to use a centralised recipe management solution, such as MePIS RM. This is a configurable software solution that digitalises all the steps in the recipe management process. It enables the creation and execution of contactless workflows for all stakeholders (something that is particularly important while we are all social distancing), secure electronic exchange of recipe data between stakeholders and machines, and central recipe storage – all while fulfilling GMP regulations (e.g. audit trail, electronic signatures, security). All this is done without any change of execution logic on production machines and process control applications.
Furthermore, the manufacturer benefits from shorter lead times, no deviations caused by human errors and substantial time-saving in the whole production process.
For more information about the digitalisation of recipe management with MePIS RM in your production, please fill out the enquiry form attached to this page.