Industry 4.0, or the fourth industrial revolution, refers to the automation and digitization of traditional industrial processes through smart technology and integration. In this concept, a “smart factory” is characterized by machines that are interconnected, interoperable and able to process data autonomously. These “smart factories” require only limited decision-making or human intervention and are therefore sometimes referred to as “intelligent automation”.
Innovation and operational excellence are two important pillars of Bachem’s success. Thus, to maintain technological leadership and high quality services, it was essential to initiate our digital transformation and enter Industry 4.0. This will benefit our customers, as we will be able to increase our capacity with more agile and flexible production, simplify and improve our GMP documentation, and provide a safe, reliable and scalable manufacturing process with a consistent quality API.
Why do we automate and digitize SPPS at Bachem?
Production optimization is crucial for us to help and support our customers in their drug development and manufacturing processes. We began our journey to Industry 4.0 by automating and digitizing one of our core business processes, solid phase peptide synthesis (SPPS) (Figure 1).
Figure 1 – Intelligent production of peptides by Bachem via SPPS
We have automated our SPPS process so that operations can be performed with minimal human intervention, improving process reliability, reproducibility of results and safety, while significantly increasing the profitability of operations. Through automation, we are able to optimize equipment utilization and reduce operating times and staff time to a fraction. This reduction allows for greater production capacity, efficiency and agility and provides more flexibility to undertake new projects. Bachem has also invested in digitizing the production process so that documentation can be done paperless. Additionally, we can improve first-time-pass (FTR) rates, data analysis by implementing a plant information (PI) system, and higher data security and integrity.
Our process innovations
As the first steps towards our “intelligent factory”, we have introduced some major innovations. Bachem’s first robot operator, BALU, was designed and programmed to support the commercial scale of SPPS. BALU manages the containers with the amino acid powders and is able to transfer powder to the activator tanks for our 150L SPPS reactors. And the robot does this without the intervention of an operator. BALU can perform other critical tasks, such as cleaning the amino acid transfer port to prevent cross-contamination. A barcode reader that reads labels on amino acid containers ensures correct handling.
Figure 2 – Roles of the robot in the SPPS
Another innovative feature of this new fully automated SPPS process is Process Analytical Technology (PAT), which performs online analyzes after key steps. PAT removes the need for manual in-process controls (IPCs) and provides better control of critical process parameters (CPPs). Additionally, this automated process allows for paperless data logging and analysis as well as cGMP documentation. Implementing PAT in our process control decreases human inputs and cost of goods. This is because manual tasks are no longer needed and free up resources for other tasks and projects. Additionally, PAT leads to higher reproducibility with minimized side chemical reactions. Ultimately, we are using our assets more efficiently and streamlining our production schedule for increased capacity and flexibility.
Our digitalization strategy
Our digitization of the SPPS process was approached in the following way: the production floor control system (levels 1 and 2 of the automation pyramid, see Figure 2) was integrated with the manufacturing execution system (MES, level 3 in Figure 2). The MES has three essential tasks:
direct the process control system by defining the sequence of operations to be performed (as written in the MES recipe, also called Master Batch Record, MBR)
record all events, process values, alarms, as they occur during the process, and finally generate the electronic batch report, eBR
manage equipment without the need for physical logbooks.
MES documentation is therefore completely paperless while being fully GMP compliant!
Full digitization is achieved by connecting the MES to our ERP system, SAP (level 4 in Figure 2). Process order executions, direct debits and stock creations, material flow and stock control are thus also fully automated and paperless. Finally, our digitization strategy includes real-time logging and permanent archiving of data on a Historian platform. This PI system provides real-time, remote plant monitoring and easy access to data for trending and lot-to-lot comparisons. This provides the foundation for future predictive and prescriptive data analytics.
Figure 3 – The Automation Pyramid
Bachem will embrace a “smart” future with our customers
Bachem, as CDMO, has implemented a new level of automation and digitization to meet the expected increase in capacity and compliance demand. We have increased the efficiency of our processes in terms of time, cost, supply and distribution. Entering Industry 4.0 and developing our “smart factory” represents a big step forward for our customers by ensuring faster interaction and more flexibility in manufacturing and sharing documentation.
Digitalization and automation initiatives are multiplying rapidly and, in the years to come, thanks to our experiences in SPPS, an increasing number of processes will be transformed in this way. With these innovations, we maintain our technological leadership and set a high industry standard in the best interest of our customers!
Implementation of Industry 4.0 concepts for the manufacture of “Tides”
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Bachem is a leading innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
With over 50 years of experience and expertise, Bachem provides products for research, clinical development and commercial applications to pharmaceutical and biotechnology companies worldwide and offers a full range of services.
Bachem operates internationally with its headquarters in Switzerland and locations in Europe, the United States and Asia. The company is listed on the SIX Swiss Exchange.
Bachem Holding AG published this content on July 11, 2022 and is solely responsible for the information contained therein. Distributed by Public, unedited and unmodified, on Jul 11, 2022 3:33:00 PM UTC.
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