Recent advancements in mRNA cancer vaccines have highlighted the potential of personalised medicines, but this brings unique challenges in production and scale-up. 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.
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Key insights:
- A digital transformation to contend with biopharma's challenges will need to be implemented to monitor processes and manage flexibility throughout the manufacturing process of personalised medicine.
- Automation and smart software platforms are becoming more commonplace in pharma manufacturing and will be essential in the new generation of therapeutics.
- A common issue raised against personalised medicine is the collection and storage of patient’s genetic information, so protecting confidentiality should be a fundamental concept in production.
- The zenon Module Type Package (MTP) Suite can optimise production efficiency by allowing a task to be subdivided into small modules that can be standardised.
Messenger 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% 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. 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.
Scaling up with modular production
zenon is also developed compliant with IEC 62443 industrial safety standard and offers state of the art security against unauthorised access. One common issue raised against personalised medicine is the collection and storage of patient’s genetic information, so protecting confidentiality should be a fundamental concept in production.
The zenon Module Type Package (MTP) Suite can optimise production efficiency by allowing a task to be subdivided into small modules that can be standardised. The system’s intelligent interconnection can connect these modules in multiple ways to suit the operation — it is essentially plug-and-produce.
The platform’s features are not just advantageous in the manufacturing stage — it can even prove useful in large molecule drug design and development. It meets IPSE GAMP 5 Guidelines for software category 4, allowing swifter system validation. zenon also meets the requirements of GMP and FDA 21 Part 11 for strictly validated production environments. The quicker validation and consistent compliance allows pharmaceutical companies to develop, design and test vaccines and biopharmaceuticals with a much faster turnaround time.
Medicine is evolving, with advanced technologies and revolutionary new therapeutics changing the face of the industry. To keep this momentum and to produce personalised medicine on a larger scale, digital transformation will be essential. Smarter processes and automation will allow manufacturers to expand into this growing field while remaining compliant to its strict regulations, allowing them to offer more pioneering new treatments than ever before.