It is incredible to reflect on 21st century advances in life sciences. The mapping of the human genome was completed in 2003, and the gene responsible for a cancer’s surface cell protein was identified.
Medications are now available to block these proteins and prevent cancer cell growth. The intricacies of the immune system are more understood now than ever before, resulting in new products enabling a patient’s immune system to fight off cancer cells.
Driven by a deeper understanding of related sciences, pharma manufacturing has advanced to support these and other developments. The result is processes with higher titers, concentrations and yields. Technologies have blossomed to support these developments including greater processing power and more storage space — along with availability of data and search capabilities far beyond what was once imagined. This intersection of sciences and technology innovation, coupled with business drivers, represents an inflection point for life sciences.
More treatments are available now than ever before, but new therapies are still needed. Companies must make a profit to stay in business and invest in acquisitions, partnerships and R&D. Therefore, better ways of operating are emerging to drive down costs, making more products available to more people. For example:
Single-Use Processing: First used in research and development, more companies are leveraging single-use in full-scale manufacturing. Advantages include a smaller manufacturing footprint, fewer cleaning chemicals, less energy usage and more production flexibility. Challenges include more complicated setup, tracking of additional components and disposables waste handling.
Continuous Manufacturing: This technique has been in lab development for several years, and there are now some early adopters receiving regulatory approval for production systems. The most significant benefit is higher production capacity within a smaller footprint. Challenges include in-process monitoring, material traceability and deploying new control schemes.
Pharma 4.0: As digital technology continues to blossom, the trend to use it to meet business demands across the value chain has been dubbed Pharma 4.0. This includes IoT, data exchange in the manufacturing space, cloud-based solutions and more. Capturing more data and putting it in context — then using it to build models manually or automatically — can help pharma manufacturers prevent problems, react to issues and optimize processes. Challenges include lack of standards from systems in terms of data origin, and understanding causation and not just correlation.
Personalized Medicine: The ability to treat a patient population with common characteristics is becoming more viable with the recent regulatory approval of the first CAR-T cell therapy product. Potential benefits are tremendous because the patient receives the exact treatment for their specific circumstance, and no more, reducing side effects. Challenges include complete traceability to ensure the right product gets to the right patient, in-process tracking of many batches, and the tremendous amounts of stored data needed for individualized batches.
These advances are helping industry leaders bring safer, more affordable and effective therapies to patients faster. Automation — including enhanced process modeling, predictive analytics and plug-and-play solutions — is a critical lever for capitalizing on these trends.
These trends are making a global impact, and there is synergy among them. Single-use solutions can be deployed to help commercialize products faster and expand manufacturing by scaling out rather than up, and to make personalized meds. Pharma 4.0 is relevant across all these trends, as more analytical models will be used, and more data will be generated and analyzed.
As these trends continue to be successfully implemented, we can look forward to a world where more diseases are eradicated, or at the very least managed better. New and improved technology will propel us into this future with various automation components underpinning success. Suppliers to the life sciences industry are investing in these technologies, and in turn investing in patients by developing/improving products and services to meet future demands.