Meet our guest writers:
Lance Holland - As Continuous Improvement Champion at Shire, Lance aligns business needs with operational excellence and lean management.
Jeffrey Simeone - Experienced in both chemical engineering and process improvement, Jeffrey is Associate Director of Production Technical Support at Shire.
David Lai - Specialized in managing efficient and compliant manufacturing transitions as well as team development, David is a Manufacturing Supervisor at Shire.
Over the past decade, we have seen how new technologies, such as cloud-based software and mobile phones, change the way we live, work, and play. However, in a highly-regulated industry like biopharma, such technologies often take longer to be adopted.
Despite the conservatism of our industry, we see several disruptive technologies having a meaningful impact on our work. Here, we discuss a few of these trends and how we see them solving key problems in the industry and beyond.
Biopharma - from early discovery to commercial manufacturing - mandates the gathering of data from physical processes. From lab-scale to industrial-scale bioreactors to purification, we use devices (e.g. instruments, sensors, etc.) to facilitate the production and/or transformation of material. Given the value of this material (active pharmaceutical ingredients) and data associated with it (reproducibility, compliance), it follows that the Internet of Things (IoT) will transform our industry.
In the case of large-molecule manufacturing, it is hard to monitor all aspects of a process simultaneously and make real-time decisions based on instantaneous visibility. Using IoT, we could stream all active processes and aggregated data to a single dashboard.
Such a capability would enable us to improve operational efficiency, react more quickly to suspected issues and known deviations, and digitally generate batch reports that would help eliminate manual intervention and human-related errors.
Akin to the value of IoT in small molecule synthesis, as described by Theo Martinot (here), IoT can truly improve the large molecule manufacturing process.
Over the past twenty years, the rise of large-molecule medicines prompted major investments in bioprocessing capabilities. Mammalian cell culture processes, for example, are dynamic and highly complex. They require constant monitoring and adjustments. Using IoT, we believe we can have a more complete and consistent view of each bioprocess.
As we record data from each cell culture batch, we believe that new technologies, like artificial intelligence (AI), can make use of data in innovative ways.
In a manufacturing context, for instance, AI can analyze real-time data from a manufacturing run, juxtapose the current performance from past runs, and adjust parameters (e.g. flow rate, temperature, pH, O2, etc.) in real-time.
In this context AI could be incredibly impactful with the capability of increasing yields and minimizing human intervention, thereby reducing human-related performance issues.
New therapies that leverage ones’ own cells to treat disease, like cancer, provide a tremendous opportunity. Over 500 new personalized medicines are currently in some form of late stage development.
The method of studying and manufacturing these treatments is fundamentally disruptive: traditional protocols and systems won’t work.
First off, the work done at R&D scale must account for additional compliance requirements as human samples are being used. Second, conventional large-scale manufacturing is irrelevant as the patient population of a personalized medicine is only one! Therefore, GMP-quality manufacturing must be performed at R&D scale. In our view, the aforementioned trends of IoT and AI can help address some of the challenges we observe with this new type of remedy.
We are emboldened by what the future holds for the biopharmaceutical industry. Not surprisingly, the technological advancements mentioned above have already transformed several other industries. In time, we anticipate that these trends will also transform the pharmaceutical industry.
The challenge for biopharma, however, is to leverage these technologies despite the increasing regulatory scrutiny of our domain.
The biopharma company that is first to market with these innovations (like IoT and AI) will realize an unprecedented competitive advantage over their peers.
This edge is much like being first to market with a new compound. The implementation of all of these innovations will also require collaborating with and educating regulatory bodies. Such agencies have a tremendous responsibility in safeguarding the manufacture of medicines, however, new perspectives on compliance and process design space will need to evolve in the future.
The authors would like to acknowledge Gab Ricci and Dawn Irish for their work in supporting and advancing digital innovation. Their commitment to improving the biopharmaceutical industry inspired us to write this piece.
The views expressed in this blog are those of the authors and do not necessarily represent the views of Shire.
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