September 1, 2009 (Vol. 29, No. 15)

Looking at the Rationale for the Agreement and What the Two Companies Plan to Offer

SAFC Biosciences and Sartorius Stedim Biotech recently signed a global partnership agreement that combines Sartorius Stedim Biotech’s expertise in filtration and liquid-handling systems with SAFC Biosciences’ proficiency in development and manufacturing of cell culture media and downstream purification products.

The companies will combine their expertise in generating application data on filter and mixing performance with critical purification buffers and cell culture media. Similarly, extractable and leachable data will be generated with buffers and media, and with filters and biobag combinations.

In addition, SAFC expects to utilize Sartorius Stedim Biotech’s technology for storage and mixing of cell culture media to optimize its fluid/powder handling system.

To obtain a further perspective on the agreement, GEN interviewed Maik Jornitz, group vp, product management, filtration/ fermentation technologies at Sartorius Stedim Biotech, and Bruce Lehr, director of marketing at SAFC Biosciences.

Maik Jornitz

Bruce Lehr

GEN  What was the rationale behind the agreement?

Jornitz: Most of the equipment needed for bioprocessing is already in our product portfolio. However, when you look at an optimal bioprocess, it’s not just about the instrumentation. Medium is a key component as it impacts the cell expression rate and the downstream process itself.

With the high cell expression growth rates now being achieved in the biomanufacturing business, the purification step has become a bottleneck. We believe we have to develop and optimize the entire bioprocess, and we think we can do this in partnership with SAFC because of its long experience in the media market.

Lehr: Both companies have a similar business model and philosophy. Both strive to form close relationships with key accounts that are leaders in the marketplace. We try to understand what their challenges are throughout their production processes. Our goal is to bring consultative help and provide customized services.

As we view the entire production train, both companies understand that we have strengths and gaps in our product and service offerings. By working together, we can fill a lot of those gaps and complement each other quite well to serve even more of a customer’s needs.

GEN What does each company bring to the agreement in terms of its expertise, technology, and products? And what was the gap that helped influence your company to do the deal?

Jornitz: Regarding a gap, we are not experts in cell culture media. SAFC has that expertise. Our forté is that we provide the equipment in which media are utilized, e.g., mixing devices for media prep, holding devices like disposable bags, media filtration, and both disposable and stainless steel bioreactors.

Sartorius Stedim Biotech also offers validation services. We can validate, for instance, a particular media filtration step in regard to mycoplasma or other microbial retention. In addition, we have Discover® Plant, Process, and System Survey, a service where our team of experts comes in and looks at an entire bioprocess or pharmaceutical process. We subsequently report our findings to a client and make suggestions on how the client can improve its biomanufacturing capabilities. These kinds of surveys can be done in the future together with SAFC.

Lehr: Our core competencies have been in media development and related cell culture products used in bioreactors. But all of our products also have applications in filtration, mixing, and liquid handling. By combining with Sartorius Stedim Biotech’s strengths in those areas, we can provide much more in terms of support services and development expertise to help clients better integrate use of our products into their overall biomanufacturing operation.

GEN  What is the importance of this agreement between Sartorius Stedim Biotech and SAFC for biopharmaceutical manufacturers?

Jornitz: It really represents a one-stop shop. Clients no longer need to fish around for media or buffer and then introduce this material into disposable bags by themselves. The agreement will make life easier for end users and ease the burden of media or buffer preparation.

As I mentioned earlier, the ultimate goal for both companies is to develop with the client optimal upstream and downstream processes to achieve the best expression rates and still retain a high yield on the downstream side.

Lehr: Right now, both companies sell their product lines into the biomanufacturing and pharmaceutical processing space. Although SAFC is expert in creating media for growing cells and supporting production, we don’t necessarily have a lot of expertise regarding optimal filtration of that media or concerning some of the production issues involved with downstream processing.

Working with Sartorius Stedim Biotech, we can use the two product lines together to help customers develop a more consistent manufacturing environment. We will be able to offer sourcing advantages and technical expertise from two different angles. For example, for an operation like filtration, we can add what we know from a media design standpoint and Sartorius Stedim Biotech can bring in its knowledge about the actual filtration steps. The result will be a better solution for customers so that they have a more optimized process.

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