Executives at Emerson’s Automation Solutions business in Singapore believe the life sciences sector is at an inflection point. In a wide ranging discussion with ARC coinciding with the launch of a 10-week webinar series, Life Sciences.NOW, ChowYang Neo, director of marketing, systems and software, and Atul Tripathi, associate director, digital transformation solutions, highlighted the intense focus on vaccine development and new drug therapeutics required to ameliorate the COVID-19 pandemic. This further emphasizes the need for life sciences manufacturers to boost capacity and throughput while maintaining rigorous attention to quality and adherence to regulations.
While COVID-19 adds to existing industry challenges, such as the rising demand for modern medicines from Asia’s burgeoning middle class, growing complexity of regulations, and long research-to-market durations, the increasing availability of new digital technologies provides an opportunity for manufacturers to reach necessary higher levels of operational excellence. And Emerson’s determination to help them on that quest certainly came through during our discussion.
As an industry, life sciences is a sector seeing strong growth in the region, with countries like China, India, Korea, and Singapore expanding their domestic production footprint over the last several years through the activities of the Big Pharma players, and increasingly, homegrown companies, many of which specialize in contract manufacturing.
The new facilities, often co-located in specially built business parks, all need to be equipped with the core drug-making production technology and also with control systems, instrumentation, and software for plant floor manufacturing execution, facility planning and scheduling, and asset management, all of which Emerson supplies to clients in the region.
The mainstay of Emerson’s offering to the life sciences industry continues to be the DeltaV distributed control system, which has now over two decades of deployment in facilities worldwide. As ChowYang Neo emphasizes, its success is in a large part due to working closely with customers to understand how to support them in key areas, such as GMP implementation and FDA regulation adherence. Hence, DeltaV systems fulfil key requirements around change management, traceability and data integrity through functions for version control, compliance reporting and audit trails and supporting the electronic signature requirement of the FDA’s CFR 21 part 11.
In September, Emerson launched the DeltaV Life Sciences OEM Program. By implementing Emerson technologies, like the DeltaV PK Controller and CHARMs, equipment suppliers to the industry can more easily integrate their equipment and skids into balance of plant systems and better orchestrate data across the drug lifecycle. The program’s aim is to ultimately drive better outcomes for patients by accelerating technology transfer and moving rapidly from research to full manufacturing, something that is highly relevant in these COVID-19 times.
While the DeltaV DCS (now at Version 14) continues to get regular additions and improvements, such as cloud engineering capability and the fast DeltaV PK Controller, a relatively newer product targeted specifically at life science laboratories is DeltaV Discovery, which improves technology transfer and reduces scale-up time by providing a “virtual DCS” with full functionality of DeltaV system in a single workstation (no separate controllers or I/O cards) in the lab. For Emerson customers using DeltaV Discovery, the process of moving, or scaling up from lab to plant, is eased through the use of tested control strategies and, hence, reduced engineering effort.
The increasing acceptance of industrial wireless networks opens the door to wider use of mobile devices, which help to boost communications and collaboration between teams on the pharma plant floor. With the DeltaV Live HMI, which natively supports HTML5, operators can easily access Emerson’s DCS from remote locations in the plant. Mobile device deployment also reduces the need for traditional operator HMI stations that take up valuable real estate in the facility.
Digital transformation can be a confusing area for companies across industries, especially with the avalanche of terminologies and information and the hawking of all sorts of technologies that promise a new digital nirvana. With its output impacting the health of people’s lives, the life sciences sector is inherently conservative in adopting new technologies and hence relatively slow when it comes to digital transformation. As such, it is important for companies in this industry to resist the temptation to throw shiny technology into the plant and hope some of it sticks. A much better approach is to develop a clear-sighted view of what is achievable and plan and execute in stages.
To encourage customers to take a logical roadmap approach, Emerson uses the Digital Plant Maturity Model (DPMM) in initial engagements with life sciences customers. Developed by the BioPhorum Operations Group, a consortia of end users, equipment suppliers, technology suppliers, academia, and regulatory agencies, the five-level Digital Plant Maturity Model provides a framework for evolving production capability in a facility.
The DPMM describes the stages of maturity right from Pre-Digital paper-based plants (1) to Digital Silos (2) to Connected Plants (3) and right through to more advanced stages of Predictive (4) and Adaptive Plants (5). Companies can use the model to identify their as-is state and understand how they can progress from this, while Emerson uses the DPMM to articulate how its solutions apply at the different maturity levels and to develop new solutions to support the industry.
Emerson uses Biophorum’s Digital Plant Maturity Model (DPMM) to encourage life sciences customers to take a logical approach to digital transformation.
Emerson’s Syncade MES is often integrated with DeltaV system to help companies move to DPMM Level 3 by enabling electronic batch records and creating, managing, and executing recipes, workflows and orders. In Korea, where Atul Tripathi spent several years implementing projects in the country’s booming life sciences industry, pharmaceutical manufacturer Handok found Syncade MES invaluable as it strove to enter the global drug market.
While potentially lucrative, Handok’s strategic move brought new pressures on meeting industry compliance requirements, something difficult to achieve with its extensive paper-based recording systems. After implementing several Syncade MES modules, Handok moved to a 90 percent paperless operation company-wide and saw significant improvements in batch release time and weighing & dispensing efficiency.
The travel restrictions and social distancing resulting from COVID-19 make it more difficult for companies to get workers trained on actual physical equipment and production processes. As such, Emerson is fielding more inquiries about its virtual reality-based training solution, Mimic Field 3D, which gives personnel simulated hands-on experience on equipment operations and on the proper procedures before entering, for example, potentially hazardous plant areas.
Aside from operator training, Emerson’s Mimic simulation software provides real-time simulation of plant processes and behavior, thus enabling control system development, testing, and optimization. And, Mimic software adds first-principles, dynamic models of process plant unit operations designed for high performance simulations.
While digital twin solutions are seeing increasing adoption across industries, Emerson notes Mimic’s particularly strong capabilities for life sciences processes and equipment. In addition, the company is undertaking initial work with customers to explore the advantages of using Mimic together with Emerson’s Real-Time Modeling System.
Since the pandemic, Emerson is fielding more inquiries about its virtual reality-based training solution, Mimic Field 3D, which gives personnel simulated hands-on experience with plant equipment.
Following the 2019 acquisition of Bioproduction Group (Bio-G), a new Emerson offering to the life sciences industry is the Real-Time Modeling System, which can help ensure that a facility’s actual production is in line with designed production capacity. Aspects that can negatively affect target production rates include equipment bottlenecks (from running multiple batches), scheduled maintenance, and availability of manpower.
These and other constraints are modelled and quantified by the software before commencing production and appropriate adjustments made to ensure no lost production time. This advanced approach to scheduling is helping life science manufacturers save millions of dollars annually, says Emerson, and is especially relevant in a time where high drug production volumes are needed.
Life Sciences Learning
Many of the topics discussed during the ARC/Emerson meeting are reflected in the agenda of the Life Sciences.NOW Asia Pacific Webinar Series (17 September – 19 November), which is seeing tremendous response from companies across the region looking to catch up on industry trends and get familiar with new and relevant technology solutions in an interactive format, says ChowYang Neo.
Those topics include: Apply the Digital Plant Maturity Model to Transform your Operation; Deliver Value of Electronic Batch Records and Phased Deployment; Optimize Life Sciences Facility Throughput; and Get to Market Faster and Reduce Risk with the Emerson Digital Twin. All webinars are also available on demand to those who register for the series.