Pharmaceutical & medical
SMART MANUFACTURING FOR PERSONALISED MEDICINE
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essenger RNA (mRNA) is an underpinning part of vital biological processes, but interest is growing in its potential therapeutic applications. mRNA
was the foundation of the most profitable and important vaccines to date - the ground- breaking COVID-19 vaccines - and now attention is turning to how this technology can treat other diseases.
An experimental personalised cancer vaccine from Moderna has shown effectiveness against melanoma when combined with Merck & Co Keytruda immunotherapy, cutting the risk of recurrence or death by 44 per cent compared to immunotherapy alone. The vaccine uses mRNA sequences tailored to the unique mutational signature of each patient’s tumours to stimulate the production of neoantigens and elicit an adaptive immune response. Though this type of treatment shows significant promise, manufacturing and scaling up production of personalised medicine like this will be a challenging process.
UNIQUE MANUFACTURING CHALLENGES Personalised medicine will require fully individualised processes from start to finish, from ordering, manufacture, tracking and storage. Tailored vaccines will also need to be frozen and kept in suitable cold storage for several months across the duration of a patient’s treatment. The model for these systems exists on some level thanks to the growing manufacture and use of biologic therapies, but this is limited to a relatively small number of pharmaceutical companies and still requires development. To produce personalised therapies, manufacturers will need to coordinate both surgical procedure and genetic sequencing.
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Recent advancements in mRNA cancer vaccines have highlighted the potential of personalised medicines, but this brings unique challenges in production and scale-up. Here, James Zaremba, sales director at automation specialist COPA-DATA, explains how specialised software can help to navigate the complexities of this new generation of pharmaceutical manufacturing.
Following manufacture of the therapy itself, it must be prepared on a strict schedule and stored appropriately in the meantime. Some of these challenges have been addressed in biologics manufacture, but scale-up will require implementation of new processes and new capability in software and supply chain. Production of large molecule therapies will undoubtedly bring challenges in manufacturing overall. In any life science operation, repeatability is key, and this is where automation comes in. Ensuring a process is carried out precisely and accurately every time removes the risk of human error and ensures consistency. It also allows easier switching between experimental processes and when paired with appropriate scientific instrumentation, it can make increasing throughput and reproducibility more straightforward. Data will also play a key role in building a robust model for personalised medicine manufacture. For a process as intricate and tightly regulated as biopharmaceutical production, traceability, collection, storage and access to data at every stage is absolutely essential.
EMBRACING AUTOMATION FOR BIOLOGICS
The unique demands that personalised medicine will bring will require smarter, more advanced methods. Automation and smart software platforms such as manufacturing execution systems (MES) are becoming more commonplace in pharmaceutical manufacturing and will
undoubtedly be essential in this new generation of therapeutics.
The industry has historically been somewhat resistant to digitalisation, employing outdated paper-based approaches to data handling, but more companies are seeing the benefits of embracing automation and smart technologies.
Implementing software solutions into any pharmaceutical operation is highly beneficial for increasing throughput, improving monitoring and minimising risk, particularly when there are stringent safety standards to meet. Digital platforms are a valuable tool for ensuring that data is collated and managed at every step of the production process for full visibility, something that will be a top priority in personalised medicine. The ability to trace samples at every stage and to monitor conditions and safety parameters will help to create models able to contend with the challenges of biopharmaceuticals. Pharmaceutical manufacturers planning to begin offering personalised therapeutics will need to invest in digital solutions to connect their equipment, monitor their processes and maintain flexibility. The zenon software platform from automation developer, COPA-DATA, is a customisable solution, and it has been developed with modern pharmaceutical operations in mind. Fully Good Manufacturing Practice (GMP) compliant and easy to integrate with new and existing equipment, it allows operators to seamlessly track products, manage recipes and generate comprehensive reports.
June 2023 Instrumentation Monthly
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