Pharmaceutical
Automation Innovation Delivers Boundless Opportunities for Life Sciences Industry
By Nathan Pettus
By Nathan Pettus
The pace of innovation and adoption of digital technologies in the life sciences industry has accelerated dramatically in recent years. As prescription spending in the United States hit a record $772.5 billion in 20231, continuing a decade-plus growth trend, consumer demand is holding the industry’s feet to the fire for faster and greater access to medicines.
With more emphasis on continuous manufacturing and personalized medicines, pharma and biotech processes must be more agile, flexible and scalable than ever to move innovations quickly and consistently from the R&D pipeline to the commercial market. To make that happen, automation has become a non-negotiable for the life sciences industry.
Automation technology and software play a critical role in quickly providing efficacious life-saving medicines and therapies to patients. In addition to lowering costs, automation reduces manual touchpoints eliminating many associated opportunities for errors and contamination; enables digital integration for reproducibility, traceability and regulatory compliance; and additionally, drives competitive differentiation among life sciences companies.
As the life sciences industry has incrementally digitalized both manufacturing and several business processes, companies now have access to volumes of valuable data – but too often, that data is isolated in system and organizational siloes. The automation architecture of the future will provide a holistic view of operations, and Emerson is making strong progress on this charge, starting with a new vision—one of Boundless Automation™.
Our Boundless Automation vision is driving the development of a new software-defined automation architecture designed to seamlessly connect and contextualize data from the field to the edge and cloud to deliver unparalleled insights across the life sciences innovation pipeline from development to commercial manufacturing.
By enabling the free flow and democratization of data across operations, life sciences companies will have a stronger ecosystem to meet their most pressing challenges, including:
Pipeline Acceleration: Getting products to market as quickly as possible
Flexible Manufacturing: Introducing new products to existing plant sites and quickly changing from one product to another
Operational Integrity: Being a reliable supplier and ensuring manufacturing facilities can meet production schedules and deliver quality products
Real-Time Release: Optimizing the review and release processes to save time and reduce losses
Sustainability: Meeting corporate sustainability goals to eliminate waste and continue to make progress toward carbon neutrality
Pipeline acceleration through streamlined tech transfer
Leading pharma companies are exploring how to digitalize and automate everything, especially the transfer of product recipes to get to market faster. Fujifilm Diosynth Biotechnologies is leveraging the power of Emerson technologies to reduce the time and complexity of technology transfer. Faster tech transfer means faster and more effective sharing of knowledge and manufacturing data across different teams, sites and stages of development, making it easier to help companies quickly bring their treatments to market.
To further shorten the technology transfer process, FujiFilm Diosynth Biotechnologies, Merck and Pfizer are working with Emerson to develop strategies and standards for One-Click Technology Transfer™, evolving today’s life sciences manufacturing recipe transfer process into a digitalized production platform. This important collaboration is setting the stage for the next generation of pharmaceutical production.
In the future, we envision our customers will be able to digitalize product recipes and provide valuable translations between recipe requirements and manufacturing processes – in essentially one click. This strategic innovation will dramatically reduce time and costs, potentially reducing product introduction timelines from 10 to 2.5 years.
Flexible manufacturing provides newfound adaptability
Today’s new, targeted therapies require smaller batch sizes, driving companies to build more multi-product facilities with flexible manufacturing capabilities. This gives customers a faster path to regulatory approval and allows product manufacturing changes to take days or weeks, instead of months or years.
Emerson technologies incorporate tools designed to shorten user workflows and improve flexibility. Features like out-of-the-box recipe building blocks make it easy to quickly change recipe configuration without complex coding, while class-based objects simplify change management—when the object class changes, all associated objects are changed automatically as well. Our technologies are also increasingly incorporating Module Type Package-type technology tools to make integrating new equipment into the control system as close to plug-and-play as possible.
Operational integrity drives on-time performance
Delivering product orders in full is a vital mandate for pharma companies, which cannot afford unexpected production downtime. With the growth of all segments in the industry including cell and gene therapies, facilities are constantly reconfiguring sophisticated equipment and keeping that equipment running is a priority in the world of flexible manufacturing. Intelligent sensors, combined with analytics software, help identify and remedy equipment issues before they shut down operations.
Emerson’s DeltaV manufacturing execution system (MES) helps customers follow the steps necessary to consistently manufacture products and boost manufacturing efficiencies. This technology helps ensure quality and regulatory compliance, while also providing a safe work environment for employees and a quality end product for patients.
Other critical Emerson technologies in conjunction with the DeltaV MES are used to navigate the complexities of batch production operations, including batch execution technologies, real-time dynamic scheduling software, electronic records, and the lightweight, flexible, recipe creation tools in DeltaV Workflow Management. These advanced technologies help teams enforce right-first-time actions, track the progress of every step, capture the data from each step, and identify how any unanticipated scheduling changes will affect all batches being produced in the facility.
Genentech, a U.S. biotechnology corporation, relies on Emerson’s DeltaV distributed control and manufacturing execution systems at its new Clinical Supply Center in South San Francisco to help enable on-demand delivery of Genentech’s personalized medicines for clinical trials. Genentech turned to Emerson for a highly integrated, fully paperless automation platform with built-in flexibility to accommodate a range of known and unknown future therapeutic modalities.
Real-time release reduces bottlenecks
Plants rely on digital technologies such as electronic workflow, electronic batch records and quality review manager software to help identify and resolve exceptions as part of the batch record process before batch completion. Inline monitoring and real-time release testing software technologies such as DeltaV Spectral Process Analytic Technology help teams perform in-line or at-line product quality control and testing as treatments are produced, preventing delays and millions of dollars of both intermediates and products from being held in inventory while waiting for test results.
Supporting a more sustainable life sciences industry
The same technologies helping deliver safe, quality medicines and therapies to market are also enabling pharma companies to make measurable progress toward their corporate responsibility goals.
Advanced automation and real-time analytics can be effectively used to improve overall operational performance, which leads to reduced emissions, improved energy usage and lower water consumption. For example, real-time scheduling reflects current production and automatically adjusts future production to optimize cleaning and sterilization processes, minimizing delays and reducing the use of water or steam. Acoustic sensors identify steam loss from leaking steam traps so they can be fixed and improve energy usage. These automation tools are used to reduce a company’s carbon footprint.
The shift toward digitalization and Boundless Automation is key to helping the industry get life-saving drugs and therapies to patients as quickly and safely as possible while minimizing environmental impact. Emerson is a critical partner to enable digital biopharma plants to put their valuable data to work – from the lab bench to the manufacturing plant.