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MES Maintains Chain of Identity

With Cell/Gene Therapy, the treatment must be provided ‘vein to vein’ in a limited period of time—with the same rigorous controls as any other biologic. This manufacturer, not unlike others in this industry, also had additional process challenges to accommodate cell count variations in the starting material. In addition, this customer’s autologous process requires maintaining strict chain of identity across the supply chain with no room for error.

In Cell/Gene Therapy, the uniqueness of each batch requires it to be adjusted for every patient’s starting material. That’s where MES comes in: MES maintains control over a complex manual process; MES automatically tracks materials usage to an individual patient lot and maintains identity of the lot; and MES recipes help accommodate varied growth timelines for varying starting material.

MES Enables Predictability

It takes weeks or months to release a vaccine batch to the FDA for review. This big pharma customer previously had a complex batch record consisting of over 1,200 pages and taking over 30 days to complete. Every page had multiple opportunities for human error including incorrect entries, miscalculations, and executing steps out of order. Administrative controls as well as rigorous and time-consuming batch record reviews were required at the end of production to ensure product quality.

By implementing an electronic batch record in MES, this pharma manufacturer practically eliminated opportunities for error—enabling more predictable batch release cycle times, and ultimately reducing finished goods inventory.

MES Drives Down Operational Costs

There are potential applications for MES in both formulation and packaging with the end goal of getting from tech transfer to production faster and with the appropriate documentation. Tracking SKUs can be a difficult task considering all the formulation types, dosage strengths, packaging, labeling, and language requirements. A strong MES solution can help with inventory and supply chain management, as well as other functional activities such as resource planning, scheduling, and managing overall equipment effectiveness. Additionally, MES can drive lean manufacturing; thereby reducing waste, re-work, and downtime.

Generics and CMOs dedicate their business to providing services such as drug development, manufacturing and packaging for pharmaceutical companies who need production scalability. A source of long development and production lead times for product lifecycle is from data—especially when manufacturers have islands of automation. An ISA 95 MES solution can help integrate all levels of manufacturing systems—instrumentation (L0- PLCs, DCS, BAS), SCADA systems (L2), LIMS (L3), and ERP (L4)—to collect, measure, and analyze data.

Managing the challenges of data integration for efficient manufacturing is one aspect of Generic and CMO business. The most impactful use case for an MES solution is compliance. In 2022, the second most Inspection/FDA 483 observation was FDA 21 CFR 211.192 Cite ID 2027—investigations of discrepancies and failures. By sufficiently collecting, measuring, and analyzing data with an ISA 88 MES solution, batch reporting can be completed sooner, but most importantly, to meet compliance. Put our decades of MES experience to work for your data integration, recipe authoring, and batch reporting needs—regardless of your platform.

Here’s the big deal:
When you’re doing 5,000 production orders per year, saving 2 hours per order translates into 10,000 hours saved.

Meet the Continua Team at IFPAC® 2024: March 3-6

Learn About the Latest Developments in Advanced Manufacturing Technologies

March 3-6 | Bethesda, MD

IFPAC 2024 ‘Navigating the Future of Advanced Manufacturing’ features key presentations from the Continua Process Systems team. IFPAC is the preeminent forum for insightful discussions about the latest trends and applications in the fields of Continuous Manufacturing, PAT, Process Control, and Data Analytics. Meet our experts at the following sessions:

Digital Twin for Continuously Fed-Batch Bioreactor

Monday 3/4 | 1:05PM-5:40PM | White Flint Amphitheater
Mechanistic models and machine learning models can capture different aspects of process behavior and knowledge. Deploying these models offers the opportunity to improve real-time bioprocess monitoring to reduce risk and optimize production. In this presentation, Continua will demonstrate the development of a digital twin for a bioreactor with both machine learning and mechanistic models running in parallel.

  • Paul Brodbeck, Chief Technologist, Continua | Presenter & Author
  • Brian Sauerborn, Lead Engineer, Continua | Co-Author
  • Dan Wasser, Industry Consultant, Continua | Co-Author

Automation and Digitalization of Drug Manufacturing Processes

Wednesday 3/6 | 1:05PM-5:40PM | Grand Ballroom H
Training and deployment of machine learning for Spectral PAT have been a staple for the likes of drug products and drug substances. As the need for data and processing power to support emerging machine learning and AI applications grows, so too does the need for modernization of the data pipes that support these applications and operations. In this presentation, we will discuss the architecture we used to deploy the mechanistic and machine learning models that made up our mammalian cell bioreactor digital twin. We will talk about moving away from monolithic applications and point-to-point integrations into distributed applications that run with much higher computational potential.

  • Brian Sauerborn, Lead Engineer, Continua | Presenter & Author
  • Paul Brodbeck, Chief Technologist, Continua | Co-Author
  • Bradley Stutzman, Control Systems Engineer, Continua | Co-Author
  • Eimantas Macys, Control Systems Engineer, Continua | Co-Author

Emerson and Continua Sign Collaborative Agreement to Accelerate Speed-to-Market for Life Saving Therapies

Software and deep life sciences expertise will unlock transformative change for manufacturers

Global software and engineering leader Emerson has signed a collaboration agreement with Continua Process Systems, a leader in continuous manufacturing process engineering and execution, to deliver comprehensive software, consulting and support solutions to help life science companies increase flexibility, adaptability and speed-to-market. Emerson will provide its extensive life sciences software portfolio alongside Continua’s subject matter expertise in continuous manufacturing and Process Analytical Technology (PAT). The resulting portfolio will help life sciences organizations build effective process orchestration as they transition from batch to continuous manufacturing.

Continua is a subject matter expert in Spectral PAT, Emerson’s in-line spectral analysis technology that improves product quality by reducing variability.

Continuous manufacturing is a key enabler for increased speed-to-market, improved process control, more consistent quality, and lower costs. Few life sciences manufacturers, however, have the in-house expertise necessary to effectively transition from longstanding batch manufacturing to complex continuous processes—especially when incorporating inline PAT measurement tools to move toward real-time, closed-loop process verification and control with automated real-time quality release. The announced collaboration will leverage Emerson’s built-for-purpose software alongside Continua’s project execution expertise to help organizations more easily achieve continuous manufacturing with integrated PAT.

Emerson will provide its solutions including its DeltaV™ distributed control system, Spectral PAT, Real Time Modeling System software, Process and Knowledge Management (PKM™) software, Mimic™ simulation software and Syncade™ manufacturing execution system to help manufacturers build a seamlessly integrated solution for closed-loop process control as a foundation for reliable continuous manufacturing.

As posted by Emerson on June 1, 2023.

Coperion K-Tron, Emerson and Continua Join Forces

Combined Strength, Commitment and Expertise Create a Powerful Turnkey System Offering for Continuous Pharmaceutical Processes

Salina, KS, USA (July 2022) – Coperion K-Tron is pleased to announce its partnership with process automation and software experts Emerson and Continua Process Systems to provide highly versatile, turnkey continuous direct compression skids for pharmaceutical and biotech manufacturers. These ultramodern modular skids are state-of-the-art fully integrated platforms that include all the hardware and software necessary for a complete direct compression tableting continuous manufacturing line. Best of all, the platforms are designed for complete modularity of the hardware and software to allow end users the flexibility to select different processes including dry and wet granulation, different unit operations, plus the ability to manufacture multiple products on a single skid. Sharon Nowak, Global Business Development Manager for Coperion’s food and pharmaceutical business states “The collaboration between the three companies has offered each of us to contribute our own state-of-the-art design, technologies, and process strengths for a completely modular, and versatile footprint, which in turn will enable further adoption and growth for continuous processing applications in the pharmaceutical industry.”

Top Features of the Turnkey Direct Compression Skid

The custom-built direct compression skid includes automatic powder dispensing via up to six Loss-In-Weight (LIW) Coperion K-Tron Feeders, combined with the end users’ blender and tablet press of choice. The process automation and orchestration are controlled by an Emerson DeltaV™ distributed control system (DCS) with Continua’s ContinuousPlant® Software Suite application platform that provides for much faster, simpler, and less costly systems integration between feeders, blender, and subsequent unit operations using the OPC-UA data exchange standard for digitally connected systems.

The Emerson’s DeltaV DCS ensures quality, compliance, and optimized implementation in a cost-effective continuous manufacturing line. From applying automation during process development to collecting data with context during manufacturing, Emerson’s DeltaV technology and manufacturing systems software solutions can improve data management, real-time product quality, reliability, and operating costs. Emerson’s solutions for Process Analytical Technology (PAT)-based manufacturing help streamline continuous processes by integrating multivariate data and real-time process models to manage critical quality attributes and predict final product quality at any time.

Designed for the Ultimate in Flexibility

The feeder/mixer skid design is engineered for the ultimate in flexibility, featuring ease of accessibility for maintenance and cleaning as well as portability for transporting the system from suite to suite. The sophisticated blend of Coperion K-Tron’s technologically advanced pharmaceutical LIW feeders and hygienic refill systems, specifically designed for continuous processes and for handling difficult materials such as Active Pharmaceutical Ingredients (APIs) and excipients, combined with Continua Process Systems’ ContinuousPlant Software Suite enables the seamless integration of real-time in-process PAT orchestrations with advanced process control, OPC-UA process equipment interoperability, and real-time RTD-based materials traceability and tracking. The ContinuousPlant user configurable Process Orchestration Layer software is uniquely engineered for modular continuous manufacturing processes and enables users to run multiple products with different processes on a single continuous manufacturing line through its recipe control feature. In the case of OSD manufacturing, this feature also allows users to make a product using dry granulation one day and a different product using wet granulation the next.

The powerful combination of these design features will enable the pharmaceutical industry to produce drugs more predictably, efficiently, faster and of higher quality using the most technological and accurate pharmaceutical feeders in the industry with the latest and most advanced real-time process automation and data management systems, and continuous manufacturing application software available. Terry Spaeth, Co-Founder of Continua Process Systems noted that “These modular digitally connected skids will give users the flexibility to reconfigure the process, and create, modify or troubleshoot recipes without having to revalidate the software resulting in better overall asset utilization of their continuous manufacturing lines.”

Coperion K-Tron Innovative Loss-in-weight Feeder Technology

Coperion K-Tron has over 4,500 pharmaceutical feeders installed worldwide with feeders currently used in the production of six current FDA-approved small molecule drugs produced on continuous processes. Its newly developed line of K3 pharmaceutical feeders was specifically designed for continuous pharmaceutical applications. The interchangeability of the QT20 and QT35 feeder modules ensures ultimate flexibility in feed rate requirements. Specialized designs for refill, difficult-to-handle materials, as well as pressure equalization ensure solutions for a variety of challenges in pharmaceutical powder feeding. In addition, the newest updates to both the Coperion K-Tron unique load cell technology and KCM-III Controller ensure the fastest weight measurements and highest accuracy performance in the industry.

Additional Service Options

For continuous manufacturers that want even more built into their direct compression skid, turnkey project options include process science/powder testing conducted in one of the worldwide Coperion test labs, complete equipment selection and even the opportunity to view equipment demonstrations prior to purchase. Modular hardware and software can be customized and designed to a customer’s specific needs as well as integrating Residence Time Distribution (RTD) models for highly accurate, real-time raw materials traceability and tracking. Process Analytical Technology (PAT), Factory Acceptance Testing (FAT), commissioning support, and validation assistance is available if a customer chooses.

Single Point Responsibility for Assured Project Success

Although the collaboration of collective minds between Coperion K-Tron, Emerson and Continua developed the custom-built modular continuous direct compression skid, Coperion K-Tron will take ownership of the full project implementation including design, construction, logistics and project management. All integration and design for the mechanical, electrical, and controls will be a joint-partnership between the three companies utilizing the team’s vast experience in executing projects for the life sciences industry.

Coperion is the international market and technology leader in compounding and extrusion systems, feeding and weighing technology, bulk materials handling systems and services. Coperion designs, develops, manufactures and maintains systems, machines and components for the plastics, chemicals, pharmaceutical, food and minerals industries. Within its two divisions – Polymer and Strategic Markets / Aftermarket Sales and Service – Coperion has 2,500 employees and nearly 30 sales and service companies worldwide. Coperion K-Tron is a brand of Coperion. For more information visit or email

Process Systems Engineering for Pharmaceutical Manufacturing

Chief Technologist Paul Brodbeck contributed to “Process Systems Engineering for Pharmaceutical Manufacturing, Vol 41 – 1st Edition”. This book is a great reference for graduates, post graduates and researchers in academia and the pharma industry as well as chemists/chemical engineers in pharmaceutical companies. It could be used for novel courses on pharmaceutical systems engineering and by regulators (eg FDA) to familiarize themselves with the current PSE methods and tools.

View Book