INTERVIEW WITH SARTORIUS STEDIM BIOTECH

The Sartorius Group is a leading international partner of life science research and the biopharmaceutical industry. With innovative laboratory instruments and consumables, the Group’s Lab Products & Services Division concentrates on serving the needs of laboratories performing research and quality control at pharma and biopharma companies and those of academic research institutes.

The Bioprocess Solutions Division with its broad product portfolio focusing on single-use solutions helps customers to manufacture biotech medications and vaccines safely and efficiently.

Interview with Amélie Boulais, Manager of Market Entry Strategy at Sartorius Stedim Biotech.

Easy Engineering: What are the main areas of activity of the company?

Amélie Boulais: Sartorius is having a strategic focus on the traditional biopharma market, serving customers developing and producing monoclonal antibodies, ADCs, recombinant proteins, vaccines; but also supporting novel modalities such as cell and gene therapies or mRNA therapies. 

We are supporting the complete workflow from our customers: molecule development, cell line and process development, upstream and downstream production. Sartorius is already recognized as a market leader in the fields of filtration, single-use technologies, and upstream processing. Since 2019, we have invested in chromatography with the acquisitions of a life science platform from Danaher Group,  BIA Separations, and the recent integration of the Novasep Chromatography Solution division.

E.E: What’s the news about new products?

A.B: The newest upgrade in our chromatography portfolio is the integration of the Novasep Chromatography Solution portfolio, now renamed Sartorius Chromatography Equipment.

The acquired portfolio comprises systems and columns primarily suited for smaller biomolecules, such as oligonucleotides, peptides, and insulin, as well as intensified equipment for biologics. Bringing R&D, technical engineering, and specialized sales and service teams under the same roof will reinforce Sartorius as a downstream leader.

E.E: What are the ranges of products?

A.B: Sartorius has a complete range of chromatography products, covering the following areas: 

Sartorius offers a diverse portfolio of chromatography systems that can be used out-of-the-box or customized to fit our customers’ requirements. Our comprehensive portfolio covers solutions from stainless steel to industry preferred single-use systems that support batch and intensified processes, i.e.. multi-column chromatography, rapid cycling chromatography, and multi-step integration.

Sartorius offers pre-packed chromatography columns for rapid screening of chromatography solutions, semi-automatic and fully-automated columns responding to the need for packing consistency, and manual columns 

Sartorius provides a complete range of chromatography resins, monoliths, and membranes to accommodate any process or any molecule regardless of size and unique characteristics, such as proteins, viruses, plasmid DNA, mRNA.

And a leading HPLC portfolio for preparative applications, designed for the purification of peptides, oligonucleotides, insulin, and other small molecules.

Amélie Boulais, Manager of Market Entry Strategy at Sartorius Stedim Biotech.

E.E: At what stage is the market where you are currently active?

A.B: Sartorius is active from process development to manufacturing scale. Our range of chromatography consumables is available in 96 well-plate formats for screening and in small scalable formats, ideal for process development. Our team of chromatography experts are visiting our customers on site and assisting them to make the best individualized choices. We also offer chromatography development services in our own labs – fully equipped to handle process and analytical method development for biomolecules up to biosafety level 2. All our consumables are scalable, ensuring a seamless transition to clinical and commercial manufacturing.

E.E: What can you tell us about market trends?

A.B: The top 3 trends we are witnessing are:

Process Intensification (PI) to face the growing pressure of increasing throughput and lower costs. PI is a holistic framework to maximize overall productivity of unit operation(s), or the facility output. Sartorius offers various intensified solutions that can be applied to both upstream and downstream unit operations that will result in increased overall productivity of your process or facility.

The rise of mRNA in the aftermath of the pandemic. mRNA is a fast-emerging class of biotherapeutics and hold tremendous promise for vaccines, but also for therapies. However, this field is still in its infancy and there are still a few challenges ahead of us. Sartorius has developed an extensive set of chromatography solutions to purify and analyze mRNA, based on the monolithic technology.

The digitalization of the biopharma industry. Our customers are increasingly adopting digital solutions to be more efficient, allowing them to make data-driven decisions, and to use predictive analytics tools. The next evolution of this approach to advanced data analytics incorporates artificial intelligence and machine learning.

E.E: What are the most innovative products marketed?

A.B: Sartorius is about to launch a disruptive technology for the capture of monoclonal antibodies, called Sartobind® Protein A. This membrane-based chromatography device is a fully proven scalable alternative to resin-based packed bed chromatography. Sartobind® Protein A uses a one-batch-one-membrane rapid cycling chromatography approach, saving time, effort, and cost associated with column handling, cleaning validation, and storage.

In the field of chromatography, we can also highlight the Resolute® BioSC systems, which can operate simultaneously and continuously three chromatography separations, including viral inactivation and in-line buffer preparation. The Resolute® BioSC also provides a route for multi-use multi-column operations. The chaining of multiple processes results in a streamlined and intensified process. 

E.E: What estimations do you have for 2022?

A.B: We will continue to grow in the field of chromatography and process intensification, with the consolidation of our new portfolio, the launch of innovative solution and the deployment of a team of experts across the globe.