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Aiming to create the ‘disposable factory’
GOETTINGEN, Germany— In an agreement that could bring biopharma one step closer to the reality of a "totally disposable factory" with integrated technologies and control systems, Sartorius Stedim Biotech (SSB) and SAFC Biosciences, both leading suppliers to the biopharma industry, announced last month a global partnership that marries SSB's expertise in filtration and liquid handling systems with SAFC's proficiency in development and manufacturing of cell culture media and downstream purification products.
The combination of the two companies' expertise in generating application data on filter and mixing performance with critical purification buffers and cell culture media is expected to provide more robust and comprehensive solutions to biopharma manufacturers. Similarly, extractable and leachable data will be generated with buffers and media, and filters and biobag combinations. In addition, SAFC will use SSB's technology for storage and mixing of cell culture media to optimize its fluid/powder handling systems.
Financial terms of the collaboration were not disclosed, but the integrated solution will be co-marketed globally to customers of SSB, which is headquartered in Aubagne, France, and has manufacturing and R&D sites in Europe, North America and Asia, and SAFC Biosciences, a member of the Sigma-Aldrich group that has manufacturing facilities worldwide. The companies will also offer their customers validation support, process improvement, technical support and problem solving.
According to Maik W. Jornitz, group vice president of marketing and product management, filtration and fermentation technologies at SSB, the agreement gives both companies' customers a fully integrated cell culture media storage and mixing solution, yielding a powerful combination of fluid management and liquid/powder systems and help them to enhance the efficiency of their cell culture processes. SAFC was the right partner for integration, Jornitz says, because its service philosophy and portfolio paralleled that of SSB.
"When you supply the entire process from upstream to downstream, including filtration, fermentation and disposal, it is absolutely essential that you acquire an experienced parner to supply the cell culture media," Jornitz says. "SAFC is a world-class cell culture media company with a lot of experience in media preparation in development, so their service queue fit very well with ours.
"For us, every partner is an integral part of our organization," Jornitz adds. "We have a philosophy when it comes to partnerships: they are not just hot air, they are absolutely essential in order to live—and for us, living the partnership is extremely important. We will make sure that SAFC is successful, and they are committed to supporting our success."
Bruce Lehr, SAFC's director of global marketing, says the deal also has many benefits for SAFC, most notably, the opportunity to partner with a market leader in process and single-use technologies development. The capabilities created by the agreement will enable the cell culture specialist to offer its customers a wide range of highly customized products and services, Lehr says.
"So far, we have received very positive feedback from our customers, who use both of us as primary suppliers in their facilities and see the benefit of having us work together," he says. "Both of us have the desire to add as much value to the process for our customers as we can. We each have different strengths within our existing product and service portfolios, so it turns out that we complement each other quite well. Working together creates shared savings, but it also enables us to create solutions that are not available right now. We expect to be able to offer a lot more value to our customers."
Ultimately, the availability of integrated technologies and control systems may bring the biopharma industry closer to achieving the creation of a "totally disposable factory," especially as productivity rates rise and create manufacturing demands, Jornitz says.
"The concept of a 'disposable factory' is becoming somewhat of a buzz word in the industry," he says. "Whether there will ever be a completely disposable factory is questionable. I foresee a hybrid solution that largely involves disposable equipment working together with disposable unit operations. In particular, when you look at the vaccine industry, which is dealing with the pandemic flu virus, we could build a production facility with a disposable factory and equipment much faster and more affordably than a stainless steel facility."
Lehr agrees, observing that the industry is seeing more and more of these trends as they envision where they can use more modular units in their manufacturing processes.
"As productivity rates have risen with cell culture systems, it has enabled some of the bioreactor requirements to be smaller than in the past and is driving them to the stage where disposables might be an option," Lehr says. "There are also obvious issues about flexibility, cutting validation costs and eliminating the large capital requirements involved with building a large stainless steel facility. The idea of people going to disposable solutions is part of a strong trend in market."