In the life sciences, bringing treatments to market quicker is no longer a bonus. Today, accelerating the treatment development pipeline is an expectation—arguably a core value—of the world’s most respected pharmaceutical companies. The pipeline for the COVID vaccine showed us that it was possible to operate differently, and companies around the globe have not only taken note; they’ve taken action.
However, accelerating the pipeline is still a journey, and that journey has a significant roadblock: technology transfer. As manufacturers leverage software and automation to perform their tasks faster, they need ways to quickly and easily manage data and scalability across the pipeline. That task can be accomplished, but only if the major players work closely together. In a recent article in Pharma Manufacturing, Emerson’s Nathan Pettus, Bristol Myers Squibb’s Chris Darrell, and FUJIFILM Diosynth Biotechnologies’ Peter Dam Madsen shared how they are focusing on collaboration to speed technology transfer and get treatments into the hands of patients far faster than ever before.
Manufacturers pave a new path
At Bristol Myers Squibb (BMS) teams are working in close partnership with their automation to develop new strategies to accelerate their pipeline from end to end. The rise of new technology provides a strong catalyst for streamlining technology transfer. Darrell explains,
“One such approach is the deployment of Industry 4.0 and 5.0 capabilities, including artificial intelligence (AI) and machine learning (ML). These advanced technologies are utilized for deeper digitalization, data mining, predictive modeling, and in silico molecular design. By providing more accurate predictions and insights, AI and ML are transforming the landscape of clinical trials. These tools can enhance the efficiency of technology transfer, ensuring a smooth transition from research to clinical trials, and ultimately, to commercial manufacturing.”
Integrating new technologies isn’t easy, but it is a critical enabler for meeting the needs of a changing marketplace. BMS works closely with Emerson to ensure that its AI, ML, and other automation technologies are rigorously tested and continuously improved, helping set the standard for innovation in the life sciences.
Standardization sustains success
Contract development and manufacturing company FUJIFILM Diosynth Biotechnologies is also no stranger to the complexity of technology transfer. As the company has shifted its focus to one targeted to end-to-end partnerships built around standardization and modularity, the company is embracing a technology strategy to digitalize and automate everything related to the transfer of recipes so that it can quickly scale up production across its sites around the globe. Dam Madsen illustrates,
“Consider a product manufactured in a uniquely designed 2k bioreactor facility. If demand skyrockets and the manufacturing must be moved to a 10k or 20k facility, the product will be subject to many delays and complexities, and the technology transfer steps will have to be reperformed with each change. In contrast, a product designed around FUJIFILM Diosynth Biotechnologies’ standardized ecosystem can be replicated quickly and easily in any size facility to expand output and reach. Moreover, such a configuration can be represented in a joint master file and submitted to regulatory authorities so the product can potentially be pre-approved for manufacture from various nodes of FUJIFILM Diosynth Biotechnologies’ standardized global network— reducing or eliminating the need to re-perform technology transfer with every change.”
Making the system work means some changes to the status quo, but they will ultimately pay off in a significant increase in the ability to scale quickly and relocate manufacturing across the globe to meet demand.
Automation suppliers support the shift
The bold changes and innovations being proposed and implemented by pharmaceutical companies cannot happen without automation. Fully manual processes and paper records cannot keep up with the continuous manufacturing speed necessary to shorten the treatment time to market. There are too many variables, and the connections between them are too critical. Pettus explains,
“Today’s manufacturers must manage a vast array of factors, including version control, maintaining the link between a recipe and its parameters, identifying where a treatment is in the pipeline, monitoring change and more. Moreover, all those elements must be translated into recipes a manufacturer can use, so it is critical to make the technology transfer process more seamless.”
Perhaps the most critical element of making technology transfer more seamless is the release of new technologies. Solutions like Emerson’s DeltaV PKM software, DeltaV Spectral Process Analytic Technology, DeltaV Manufacturing Execution System, DeltaV Workflow Management, and more are critical to empowering operators to do more in less time, providing the seamless management of treatments across the pipeline.
Yet even more important is the commitment for manufacturers and automation suppliers to work in tandem to drive innovation to further increase success. Pettus explains,
“That is why key stakeholders in the life sciences industry—across automation, research and development, manufacturing and more—are coming together to build a one-click technology transfer framework to align on a set of standards for centralized transport and translation of data. Their ultimate goal is to integrate the technology transfer process, creating a holistic product platform for management, sharing and translation of data, using open source and open standards to align on the best way to translate recipes into automation systems.”
With more new treatments coming to the market every year and One-Click Technology Transfer on the horizon, there’s never been a more exciting time in the life sciences. You can learn more about the role Emerson, BMS, and FUJIFILM Diosynth Biotechnologies will play in that future by reading the article in full over at Pharma Manufacturing.
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