Ramping up production for the COVID vaccines
Over the last year, there has been a significant global effort underway by pharmaceutical companies 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 now need to ramp up production to satisfy the huge 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 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 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 potentially numerous production facilities around the world 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 whilst 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 a huge time saving in the whole production process.
For more information about the digitalisation of recipe management with MePIS RM in your production, please contact info@iiotek.com
Press enquiries: Robin Buxton – Evestico Ltd, Bathory House, Tove Court, Rugby CV23 9SJ
Telephone: +44 (0) 1788 247272
e-mail: robin.buxton@evestico.com
Twitter: https://twitter.com/evestico
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About iioTek
iioTek Ltd is an independent Industrial IT & Automation consultancy covering an array of industry applications within the UK & Ireland.
The company are experts in delivering, supporting and advising upon the leading industry vendor products and solutions, whilst offering a wide range of data, visualisation, control, electrical design, and digitisation solutions, with extensive capabilities in Life Sciences, Power, Water, Food & Beverage, CPG, Manufacturing and Process solutions.
About Metronik
Metronik is a trusted and innovative provider of digitalisation and automation systems for life science and other industries. The company provides a comprehensive set of services, including software development, implementation, and commissioning; full life cycle and validation support; and operational consulting. The company has particular expertise in several industries – life science, food and beverage, discrete and others.
Established in 1990, the company today employs more than 160 engineers and software developers in three countries.
With headquarters in Slovenia and business partners in Austria, Belgium, Germany, Italy, Croatia, Serbia, BiH, Macedonia, Russia, Ukraine, UK and Ireland, Metronik has a strong international footprint.
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