Milestone Bioprocess Technology

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Milestone Bioprocess Technology A Partner for the Biopharmaceutical Industry

Author Anke Geipel-Kern

Sartorius offers technologies for every phase of the biopharmaceutical value-added chain – having already recognized the potential of biopharmaceuticals at quite an early stage, the company has since carefully aligned its product and service portfolio with the requirements of the industry. Today, Sartorius presents its capabilities as an innovative solution provider for biopharmaceutical research and industry.

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The production of innovative new membrane filters laid the foundations for the advanced bioprocess technology of Sartorius.
The production of innovative new membrane filters laid the foundations for the advanced bioprocess technology of Sartorius.
(Source: Sartorius)

Even large companies have to start small — with an individual driven by a pioneering spirit and a good idea. This also is how the story of the global player Sartorius started 150 years ago. When Florenz Sartorius laid the foundations for a new company in Göttingen, Germany, in 1870 that soon evolved into a “factory for scientific instruments and equipment”, he had ambitious plans — and more than enough energy to turn them into reality.

A clear vision coupled with pioneering spirit have been the driving forces behind the development of Sartorius to this day. Meanwhile, more than 9,000 employees at 60 sites work hard at this life science and biotech company to ensure that customers receive innovative tools and technologies enabling them to develop new drugs more quickly and produce them more cost effectively.

University of Göttingen — a Hotbed of Innovation

But let us return to the second half of the 19th century and the University of Göttingen. Under its official title of Georg August University of Göttingen, the university already then enjoyed a reputation of world renown, attracting luminaries like Gauss, Wöhler and Weber. The university was not only a place of research and learning, but also a source of business for mechanical engineering workshops. Particularly the laboratories in the chemistry department needed high-precision instruments like thermometers, balances, and many others, providing the foundations for a flourishing small local network of precision engineering firms. At one of them — mechanical engineering specialist Wilhelm Apel — a young Florenz Sartorius learned his trade as a precision engineer and followed in the footsteps of his father.

Today, we would refer to this inspiring network of firms around Göttingen as an innovation cluster, and the young company called Sartorius would be known as a start-up. After his years as an apprentice and then as a journeyman, Sartorius took over a shop business in the city center of Göttingen. This business included workshops, which he then continuously expanded to work on the development of short-beam analytical balances. His goal: minimize the time needed for scientifically accurate measurements and thus participate in the boom that was setting the chemical industry alight at the time.

In the process, he displayed great skill as an entrepreneur. The well-traveled young man quickly recognized that his new balance technology could only be successful if it offered his customers genuine added value at affordable prices. His plan for turning this into reality involved task sharing, modern gas-powered machines, and well-trained workers.

The Business flourishes with New Technologies

Sartorius remained on the lookout for new technologies. In the 1890s, his attention was drawn to incubators for poultry breeding, presumably at international trade fairs. He developed high-precision temperature control systems enabling steady incubation temperatures to be maintained. He soon recognized that this technology offered further potential, and just a short time later he designed incubator cabinets for cultivating bacteria.

These were used in the hygiene institutes emerging at the time and evolved into a lucrative line of business. But even the inventor himself could not have had any inkling that, of all things, these incubators would eventually be the seed from which future biotech applications would one day evolve. Even though bacterial strains were already being cultivated — advanced biotech and genetically engineered drugs were still a remote prospect in the 1890s.

Bioprocess Business Builds on the Strengths of Membrane Filters

The actual foundations for today’s bioprocess business can be traced to the development of novel synthetic filters — so-called membrane filters. This innovative filtration technique was invented by Richard Zsigmondy, winner of the Nobel Prize in Chemistry, and his scientific research associate Wilhelm Bachmann. Both were working in colloid chemistry at the University of Göttingen at the time, where they developed the filters for separation of the tiny particles. Membrane filtration was seen by many as a groundbreaking invention, as it enables scientists to remove microorganisms from heat-sensitive solutions.

Science, industry, and hygiene institutes were quick to recognize the potential of this new filtration technology. With state and commercial backing, the company Membranfiltergesellschaft mbH (Membrane Filter Company) was founded in 1927. Zsigmondy contributed his patents and became Scientific Director. Although further research initially focused on membrane filtration, sales of the filters really took off once Sartorius, previously only a joint partner, fully acquired the company.

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Breakthrough for Membrane Filter Technology

Crucial to the successful development of the company was the bacteriological department created in 1945 and headed by chemist Adelaide Beling. The department initiated a switch from wet to dry filters, unlocking new fields of application, e.g., in breweries, dairies, and in drinking water analysis. This department was also credited with the development of innovative nutrient pads for determining microbial counts. From this point ever since, nutrient pads supplied in combination with membrane filters in sterile packaging, called nutrient pad sets, are ready for customers to use straight away.

In the 1950s, Sartorius invested a great deal of its research efforts into the scientific fundamentals of membrane technology. The developers learned to better understand the relationships among structure, fine pore size, and filtration mechanisms. The number of applications and filter types then increased, with new applications added in the food industry and the first stainless steel pressure filtration devices for ultrafiltration developed. In 1969, the first plate-and-frame crossflow ultrafiltration system for larger volumes was introduced. This technology unlocked new possibilities in molecular biology and pharmaceutical production, as even the smallest harmful molecules or viruses can be removed from solutions.

Further Developments Deliver an Innovation Boost

In the 1970s, a number of developments in the field of filter cartridges, which are still the industry standard today, delivered a real innovation boost. The pleating of the membranes multiplies the surface area of the filter, yet keeps the filter cartridge to a very compact size. The scalability of this product solution opens up more flexible applications for customers. And since 1976, the bubble point test method has been providing a reliable tool for function testing.

In 1978 the company presented Minisart, the first single-use filter, thus anticipating the trend for single-use equipment that would start to become established in the biopharmaceutical industry only a few years later.

With demand for Sartorius filters also growing steadily across the world, the company decided to expand. In 1982 a factory was opened for manufacturing membrane filters in Puerto Rico — at the time, this was the first production site outside of Germany. Over the next few years, a global network was gradually established, with sites in 60 countries today, including 22 production plants.

A Game-changing Decision: Biopharmaceuticals

In the mid-1990s — Sartorius was publicly listed by this point — a game-changing decision was taken. Top management decides to concentrate on the biopharmaceutical industry, which was still in its infancy at the time, thus striking out in a new direction that will, ultimately, prove to be the perfect golden opportunity.

In 1982, Eli Lilly succeeded in producing human insulin with genetically modified E. coli bacteria in a bioreactor for the first time, and just six years later the first monoclonal antibody was launched in Germany: Muromonab, a drug given to reduce acute rejection in patients with a transplanted organ.

This marks the starting point of a technological boom — one that Sartorius has a key hand in shaping in its new role as a strategic partner for life science research and the biopharmaceutical industry. Thanks to refined therapeutic approaches and innovative gene therapies, the industry is now definitely in the fast lane — as can be demonstrated by the following numbers: In 2018, seven of the ten most-sold drugs in the world were biologic drugs, and in the same year active ingredients manufactured using biotech accounted for around a third of new drug approvals in the USA.

For the research and development department of Sartorius, the new strategy means one thing — a total focus on biopharmaceuticals. The company has set itself a clear growth strategy and is constantly expanding its product and technology portfolio for upstream and downstream processing. Alongside organic growth of the company, the next two and a half decades have also been characterized by numerous alliances and acquisitions that have helped Sartorius evolve into a successful, market-leading total solutions provider for the biopharmaceutical industry.

Acquisitions Expand the Company's Portfolio

The first major coup came in 2000 with the acquisition of B. Braun Biotech International. This purchase represents a shift away from the previous specialization in filtration applications and marked a move toward the central process step of cell culture/fermentation, as well as adding a vast wealth of expertise in system business and engineering.

Strategic innovation management has now become a key to success for Sartorius, going forward. Always with a close eye on the user, the company has been pursuing its main objective of improving existing process solutions and identifying and integrating the potential of new technologies early on.

The 2006 cooperation with Wave Biotech AG, a Swiss technology company, led to this firm’s subsequent acquisition by Sartorius. With the aid of the company’s bioreactors, which are based on wave-induced rocking motion, Sartorius was able to add yet another interesting tech development to its portfolio in the field of cell cultivation.

Stedim Biosystems Becomes the Most Important Transaction in the History of the Company

The acquisition in 2007 of French company Stedim Biosystems, the inventor of single-use bags for biopharmaceutical applications, turned out to be a highly significant milestone in the history of Sartorius. In essence, the product range of Stedim Biosystems covers two- and three-dimensional single-use, scaled-to-size bags for the transport of pharmaceutical media, plus a selection of sterile connectors and freeze-and-thaw solutions for long-term media storage. The addition of these single-use bags has made it possible to offer customers fully-assembled single-use products. At the same time, the expertise in the field of plastic film processing opened up the path to the development of scalable single-use bioreactors, such as the Biostat STR with models ranging from laboratory to process scale. The three-dimensional bags form the heart of this system and are equipped with extensive sensor systems.

Biotech Drives Business Growth

Biotechnology proves ever more to be the driving force behind the development of the business. The more recent history of the company is marked by one highlight after another: In 2009 a new factory is opened in Bangalore, in India, where bioreactors and other equipment are manufactured, among other products, for pharmaceutical clients. Following a first major expansion of filter production capacity in Göttingen in 2001, 2011 saw the start of the construction of a new building that creates additional capacity of membrane manufacturing. Alongside new casting machines, the investment also included upgrades of existing production lines.

Developments continue apace in 2012, with expansion of the plant in Yauco, Puerto Rico, increasing local capacity for tmanufacturing membrane filters and single-use bags. As well as building a new production site for bioreactors and other process equipment in Guxhagen, Germany, Sartorius also embarked upon a new alliance with the life sciences group Lonza in the area of cell culture media.

The commercial successes of Sartorius are also reflected in other areas — the company has been listed on TecDAX since 2012, the stock index that tracks the performance of the biggest companies in the German technology sector, and is meanwhile quoted on the MDAX.

On the Path to Becoming a Total Solutions Provider

Further steps to round off the portfolio were also progressing, always with a focus on the goal of being a total solutions provider. The acquisition of TAP Biosystems in 2013 filled a gap for small-volume bioreactors in the company’s offering. These fully-automated Ambr systems, make it possible to run a large number of experiments in parallel. With this range, Sartorius assists its customers in research and development in overcoming one of the biggest challenges they face: reducing the time to market maturity for a new active ingredient.

It still takes around ten to twelve years for a new therapeutic agent to be developed, and to date only around one in 10,000 potential active ingredient candidates on average actually makes it onto the market.

To offer even higher levels of service to customers, the Scottish company Bio Outsource is acquired in 2015, the tests of which are used not only in the development of active ingredients, but also in subsequent production and release processes. The acquisition in the same year of Cellca, a specialist in cell culture media and cell line development, marks an investment in process development, as does the purchase of the start-up kSep Systems, which develops fully-automated single-use centrifugation systems that are used in the production of biopharmaceuticals like vaccines, cell-based therapeutic agents, and monoclonal antibodies.

From a Manufacturer of Short-beam Analytical Balances to an Innovative Solution Provider for the Biopharmaceutical Industry
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Future Technologies in its Sights

Sartorius has also started to shift more of its efforts into the field of bioanalytical research and molecular development in the laboratory, acquiring the companies Essen Bio Science and Intellicyt in 2017, whose cell analysis systems are essential tools for research into new active medical ingredients. The year 2017 also saw the acquisition of Swedish data analysis specialist Umetrics, securing important expertise related to the modeling and optimization of biopharmaceutical development and production processes for the Sartorius Group. But Sartorius also has set its sights on the future market of advanced therapies, as evidenced by the acquisition of a majority shareholding in Israeli company Biological Industries. This provides Sartorius with access to the production of media for classic manufacturing methods as well as for the production of cell therapy medicines. The latest highlight — the acquisition of selected life science business from Danaher — only dates back a few months, but it has added several new strings to the company's bow at a single stroke. Devices for protein analysis, biosensors, and reagents for active ingredient research are being integrated into the company’s Bio Analytics unit. This is further supplemented by chromatography systems and resins that will strengthen the Sartorius technology offering for downstream processing.

A Success Story with a Bright Future

In its anniversary year of 2020, Sartorius has emerged with a new brand image and the new claim “Simplifying Progress” — a step that reflects the company's dynamic development. The Group’s ambitious growth targets highlight quite how much potential for growth there still is in the success story of Sartorius. By 2025, the company plans to more than double its revenue from around 1.8 billion euros (2019) to 4.0 billion euros. The Group aims to grow organically, particularly in the Asian and American markets. In addition, further acquisitions are expected to expand the product portfolio and increase customer benefits even further.

The steadily growing Sartorius Campus at headquarters in Göttingen, into which the company will have invested some 500 million euros by the end of the year, is a visible indication of the dynamic developments taking place within the Group. Alongside advanced office buildings, new facilities have been constructed, among other centers, for the production of laboratory instruments as well as for the manufacture and processing of filter membranes.

A centrally positioned forum offers among other things training laboratories and a large Application Center, in which customers will not only be able to access detailed information about products and technologies, but where they can also test applications. With total floor space of 170,000 m2, Sartorius Campus thus offers plenty of room for pioneers, forward-thinkers with ideas and visions, and researchers to achieve technological breakthroughs — perfectly in keeping with the ideals of company founder Florenz Sartorius.

Additional Information
Of Pioneers and Visionaries

Few stories have impressed me as much as the history of the restless Florenz Sartorius and his awareness of trends. The parallels between the early days and now are also exciting: Just like the founder, the current group management 150 years later also places its trust in cooperation with leading scientists and innovative start-ups. More than ever, R&D speed and production efficiency play a vital role in the development of new therapies and new processes. The COVID-19 epidemic has also shown emphatically that speed can be the key to survival. There is no doubt that Sartorius is right at the forefront of the developments in this regard.