View This Article in BOSS Magazine
Emerson is dedicated to providing products and services that deliver value to the life sciences supply chain from process development through commercial manufacturing.
Emerson, the American multinational corporation, has been involved in the field for decades.
“The life sciences industry is transforming itself, both in the types of products produced as well as how they are manufactured,” shared Bill Smizaski, Vice President of Global Life Sciences Operations. “Now more than ever, life sciences manufacturing is going through fundamental changes.
“There’s pressure on the industry to drive costs down and make medicine more accessible. They also need to find innovative ways to bring new therapies to market faster.”
Smizaski has 30 years of life sciences industry experience in engineering, automation, and IT. He joined Emerson in 2016 to help build strategies to address the industry’s challenges through automation and operational performance improvements.
The Shifting Industry
A big shift in the life sciences industry is a growing focus on biologics products, or large molecules. Unlike conventional pharmaceuticals that are produced through chemical synthesis, biopharmaceuticals are produced through biological synthesis in living organisms. Changing from chemical to biologic processes means new assets are required to develop and commercially manufacture biologics and vaccines.
Today, most biologics products are manufactured in capital intensive, stainless steel process trains operated with batch processes. They have limited flexibility for changeover to new products and require the equipment and piping to be cleaned and sterilized between batches. Addressing these challenges is driving manufacturers to innovate.
These innovations can take many forms. One approach is to improve efficiency and quality by moving analytical quality measurement and control from offline in the laboratory to online in the automation system. This approach eliminates the wait for lab results to make decisions and improves right first-time production.
A second strategy is to eliminate the time spent cleaning and sterilizing equipment by changing to single use technologies. Single use systems replace the stainless-steel parts that touch the product with polymer bags and tubing. When a batch is finished, the polymer parts are discarded, eliminating the need to clean and sterilize. This reduces capital investment and provides manufacturing flexibility.
The Shift to Continuous Manufacturing
One of the most significant innovations in the industry is the shift from batch manufacturing to continuous manufacturing, where the process runs until the order volume is fulfilled. One way to think of continuous manufacturing is as a single batch with subdivided lots defined by time or other logical demarcation.
Manufacturing equipment is constantly producing as opposed to less efficient, step-wise batch manufacturing with a fixed batch size. While this change was initially focused on tablet processing, continuous process development is making advances both in the chemical and biologic drug substance production.
One of the benefits of continuous manufacturing is that equipment has a smaller footprint for producing the same amount of product. You can also reduce the amount of product discarded when there is a process disruption, detect and control process variability in real time, and accelerate new product introduction.
“To start the transition to continuous, biologic manufacturers have started to implement a partial continuous and partial batch operation. Perfusion bioreactors can run for up to 90 days of continuous production. But the downstream purification is still mainly run in batch mode,” said Smizaski.
“However, industry leaders are starting to make these downstream unit operations in purification more continuous. Soon, continuous processing using single use technology will be a reality and will give those manufacturer’s a competitive advantage.”
While the benefits of continuous manufacturing are significant, challenges remain with implementation. To ensure success, manufacturers must carefully define lot and batch material tracking and reporting in a way that is different from the typical batch application. They need new equipment designed for continuous operations, reliable real-time process measurements, and advanced process analytics.
Achieving Operational Certainty
As a leading supplier of automation solutions for the life sciences industry, Emerson is dedicated to helping manufacturers address these challenges. Innovative technologies like a flexible modern automation system helps to eliminate operational complexity and project risk. Combined with integrated advanced process controls and comprehensive event and alarm management, controlling the continuous process becomes easier.
Manufacturers are addressing quality control challenges through advanced model predictive controls and analysis. As technology advancements make daily operation more effective, manufacturers are also applying these technologies to achieve improvements in the drug development lifecycle.
Standardizing automation platforms across the pharmaceutical product lifecycle can reduce the engineering effort required to move products from research to clinical trials to commercial manufacturing. By standardizing automation platforms, life sciences companies can perform process development activities in a single workstation and reduce the overall footprint of the automation system. They save time by developing the manufacturing process with the same automation platform that will be used in commercial manufacturing, making the transition to commercial production faster and easier.
In addition to technology applications, Emerson’s focus on Project Certainty gives manufacturers confidence in a successful project implementation. Project Certainty uses innovative engineering practices and design, standardized automation project specifications and strategies, and leading technologies to help organizations achieve on-time, on-budget capital project execution.
From delivering operational excellence and preventing failures of equipment, to predicting process issues before they occur, eliminating time-consuming manual paperwork, and reducing unnecessary inventory, Emerson continues to develop technology and services geared to Project and Operational Certainty for the life sciences industry.
Emerson is uniquely positioned to provide products, services, and technology solutions that fit the life sciences industry and is committed to on-going investments in the future of the marketplace.
But Emerson is about more than making manufacturing better and more efficient.
“On a personal note, during the 30 years I’ve been in this field,” said Smizaski. “I’ve had the opportunity and honor to work on many products that are lifesaving and game-changing. I know at Emerson, we feel a direct connection to improving people’s lives.”
Life science manufacturers strive to create innovative products that help people lead healthier lives. Emerson has the automation expertise, industry experience and technology to solve your greatest cGMP manufacturing challenges and create effective solutions for improving data management, real-time product quality, reliability, and operating costs. From design to implementation and startup to ongoing Operational Certainty, rely on Emerson to stay competitive in a global economy.
1100 West Louis Henna Blvd
Round Rock, TX 78681