The Siemens technology group and Sartorius Stedim Biotech (SSB), a specialist international supplier for the biopharmaceutical industry, recently announced a long-term collaboration in the area of automation. This agreement provides that SSB will preferably use Siemens automation technologies, including industrial PCs, the S7-1500 software controller, the TIA Portal and the Simatic WinCC SCADA system, among others. These hardware and software components will be employed in many products and solutions that SSB offers its customers for the development and manufacture of biopharmaceuticals such as vaccines and monoclonal antibodies.
Discussing the drivers behind the collaboration, Thorsten Peuker, Vice President, Integrated Solutions, Sartorius Stedim Biotech, commented: “From drug development to manufacturing medicines in a GMP-compliant environment, SSB has a large portfolio of solutions that covers all the technologies required to work within the biopharmaceutical sector. We’ve observed how the industry is moving into smaller batch sizes and we understand that speed-to-market is absolutely key. It was this trend that motivated us to work together.”
“As we support those pharma manufacturing companies, who are expediting the drug production process and wishing to get products to patients quicker, we’re also responding to their demands for technologies that are both simpler and more convenient to use. Our existing proprietary automation solution was not meeting those needs; so, within the company, we asked ourselves how to improve on that situation, how to proceed and how to better ourselves for the future.”
“Of course, we examined both internal options and external partnerships with a well-known industry leader who could complement our efforts in terms of speed and quality, which is how we came to be working with Siemens, a significant player in the market,” said Thorsten. Bart Moors, Vice President, Market Development, Pharmaceutical and Life Science Industries, Siemens, added: “From our perspective, what we saw, by taking a clear view of the overall industry — and not just biopharmaceuticals — was that the whole ecosystem of pharmaceutical manufacturing is rapidly moving into biologics. Our business has changed during the last 5 years to mirror that trend and, now, 70% of our pharmaceutical activities are related to the biologics industry. We already have a very successful working relationship with Sartorius Stedim Biotech and this new development is a natural progression of that collaboration.”
Bart continued: “Previously, companies have looked at unit operations and struggled to integrate them. The new trend, which is focusing on reducing the complexity of operation and working with smaller batches, is a perfect match for SSB’s technologies and Siemens’ automation solutions. As global players, we have the ability to create novel concepts for organisations that function in the biopharma and biologicals space. Right now, our offering is an open automation platform that’s designed to shorten timelines and improve the quality of novel drugs.”
“By introducing this new automation platform and further standardising our products, we are making it easy for our customers to integrate their systems into higher-level automation solutions, such as SCADA, DCS (Decentralised Control System), MES and ERP,” explained Thorsten. “At the same time, we are enabling them to enhance the scalability of their processes from lab- to commercial-scale production.”
Thorsten added: “Single-use technologies have been available for some time; however, they’ve often been limited to R&D or process development applications. Now, we can help with GMP and manufacturing areas wherein the requirements are totally different, such as data security and integrity, quality and handling. Beyond the actual functionality of our solutions, we also have to help our customers to meet their regulatory obligations.”
Customer gains
In terms of benefits, Thorsten feels that by collaborating within a team comprising experienced experts in their fields, both companies can deliver results in a much shorter timeframe compared with trying to operate alone. “As one of the leading companies in automation, we have found an ideal partner in Siemens. We believe that the co-operation agreement will both improve SSB’s offering to the market and provide substantial advantages for our customers,” he added. “Based on our existing relationship with the organisation, we’ve now converted our collective intelligence into solutions for single-use, end-to-end production systems for actives such as antibodies and vaccines.”
Compared with other sectors, pharmaceutical regulations regarding the use of automation are much more stringent, which has somewhat hampered its adoption, notes Bart. “But, this is a very innovative industry and it’s catching up. So, no matter what we develop, it’s our joint responsibility to ensure that what we put in place is both inventive and compliant … for today’s manufacturing environment and for the next 10–20 years.”
“As mentioned, as companies proceed from R&D and process development to commercial-scale production, speed-to-market is paramount. Technology is certainly an enabler, and our aim is not only to improve current drug processing operations but also to provide greater insight into those manufacturing systems to enable further optimisation to take place in the future,” Bart said. Asked whether the biologics market was a growth opportunity for Siemens, Bart strongly agrees. “It’s still, after all these years, a flourishing industry and with the ongoing implementation of automation systems, we expect to see further developments and breakthroughs very soon.”
An established relationship
Sartorius Stedim Biotech has been using Siemens automation solutions for process control in its large-scale bioreactor and filtration systems for quite some time. To standardise its own product portfolio even further, SSB has decided to introduce the new, configurable automation system for its range of systems. SSB products — such as BIOSTAT STR single-use bioreactors and FlexAct filtration systems — will be equipped with Siemens automated solutions in the coming months and will subsequently be fully compatible with process control systems such as Simatic PCS 7 and Simatic Batch.
Thorsten adds: “In essence, the partnership extends beyond Siemens all the way to our customers. We now have a team that’s dedicated to meeting industry’s demands in terms of speed and quality, and providing the solutions that our clients and, most importantly, patients expect. Siemens is a great source of industrial knowledge with a global presence; plus, they understand the technologies we’re using. This is particularly valuable in fast-emerging economies such as Brazil and China.”
With globality in mind, I ask Bart about the implementation of third-party solutions and accommodating existing infrastructure systems from other suppliers. “It’s absolutely imperative to offer an open platform,” he responds: “It enables us to implement it in an efficient and smart way and, at the same time, allows us to achieve global standardisation. Not only is this more cost-effective, we can train operators on a common platform that encourages compliance, speed and efficiency.”
“Our customers are very excited by this development,” notes Thorsten, “because it allows them to define the level of integration they want to achieve and work with both extant and original systems. An open platform approach such as this is also much faster and easier to implement.”
In summary
The ability to use the same concept at the clinical stage and the production phase brings considerable benefits to biopharmaceutical manufacturers, notes Bart, as it accelerates the supply chain and expedites time to market. “Scalability is also key,” adds Thorsten: “We want to support customers during process development and also ensure fast and efficient market supply. Flexible, end-to-end automation is critical to achieving that goal. An important aspect of that is the remote service capabilities we offer. Imagine if a system breaks down during the weekend and someone has to travel to the plant to fix the problem. That involves a lot of unwanted downtime. Now, this can be done off-site, 24/7, using the Internet. A digital solution can be used to effect a repair or diagnose a fault much faster, which reduces the cost burden and enables our customers to continue to produce life-saving drugs.” Delivering high quality, compliant goods in a cost-effective way is an industry imperative for pharmaceutical companies, says Bart: “I sincerely hope we can help these businesses on their current journeys to market and encourage them to undertake new ventures in the future.”
Offering the final word, Bart commented: “We are happy to support Sartorius Stedim Biotech with our unique and cohesive portfolio consisting of hardware, software and service throughout the entire system lifecycle. Based on our co-operation, users in the biopharmaceutical industry stand to benefit from higher efficiency, quality and flexibility, as well as faster times to market.”
