January 1, 2017 (Vol. 37, No. 1)

The New Testing Facility Will Speed Clients’ Biosimilars and Other Bioproducts to the Clinic

Sartorius Stedim Biotech opened a new bioanalytical and biosafety testing facility in Boston in November that company officials say will focus on helping U.S. companies accelerate development of biosimilars and move other bioproducts quickly into clinical trials.

GEN recently spoke to Daniel Galbraith, Ph.D., CSO at Sartorius Stedim BioOutsource, which played the major role in setting up the new Boston facility.

GEN: What was the rationale for opening the bioanalytical lab in Boston, beyond “ac-commodating the rising demand for the company’s BioOutsource brand specialized assay platforms in North America and facilitating the ongoing expansion of this unique service offering”?

Dr. Galbraith: The North American market is very important for Sartorius Stedim Biotech, as it is the largest biologics market globally. Opening a bioanalytical testing lab in Boston means we can make our testing services more easily accessible for our North American clients. So far, we have tested our client samples of our facility in Glasgow, U.K.

GEN: What specific services will you be offering?

Dr. Galbraith: The new bioanalytical testing lab will offer our biopharma clients our specialized assay platforms to conduct characterization and comparability studies for biosimilar monoclonal antibodies. Our range of unique, off-the-shelf testing services includes an array of bioassays and cell-based assays, such as, antibody dependent cell cytotoxicity (ADCC), complement dependent cytotoxicity (CDC), and enzyme-linked immunosorbent assays (ELISAs), as well as surface plasmon resonance (SPR) binding assays. In addition, we will provide a selection of in vitro and PCR assays for the detection of adventitious agents.

GEN: What types of instrumentation are available in the new facility that will be used to provide these services?

Dr. Galbraith: Our new lab features state-of-the-art instrumentation such as Biacore T200 and 4000 analytical instruments to conduct SPR assays, as well as plate readers to conduct the bioassays and ELISAs. Furthermore, all of our labs are equipped with new Sartorius lab products, such as Tacta single- and multichannel pipettes or Secura balances. 

GEN: What kinds of products, in general, will the new facility be open to for analysis?

Dr. Galbraith: We specialize in the testing of biosimilar monoclonal antibodies. As some of our methods are platform based, such as SPR, they can be used to test innovator monoclonal antibody products as well. Our biosafety assays can be used to test a wide range of biologics, most commonly monoclonal antibodies, viral vaccines, and cell therapeutics.

GEN: How specifically will the services you offer “help customers accelerate into clinical phases?”

Dr. Galbraith: We recognized from an early stage that speed was going to be a major factor in the development of biosimilars, which is a highly competitive market. Time is of the essence as the first to market will reap the most benefits. Therefore, we pioneered the development of off-the-shelf assays to improve speed-to-market for our clients. All of our biosimilar monoclonal antibody assays are available off-the-shelf, meaning they are predeveloped and qualified, and client samples can be run without any upfront development. This saves our clients considerable time and cost, accelerating the early stages of development into clinical phases.

GEN: Sartorius officials have remarked that the facility opened in Boston because that city is a U.S. “biotech hub.” There are at least seven or eight other biotech hubs in the U.S.? What specifically about Boston influenced the decision to set up the new lab there?

Dr. Galbraith: Sartorius Stedim Biotech is customer-focused, and we recognize the need to be close to our clients and offer them excellent customer service. As we have a high number of existing clients in the Boston area, it was an obvious choice for us to pick Boston over the other biotech hubs in the U.S.

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