DCSIMG

DSM in Pharmaceuticals

Outstanding facilities

Our nine pharmaceutical R&D and manufacturing facilities are spread across the globe and cover all major pharmaceutical manufacturing technologies and capabilities – and all with an outstanding regulatory record.
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Our research center in Geelen in the Netherlands and our Biotechnology Center in Delft work with customers on a range of early stage projects; while our major facilities in Linz, Austria, and Greenville, North Carolina offer full-scale cGMP primary and secondary manufacturing.

Geleen

Our research center in Geleen is the home of our research team and includes a range of catalytic technologies where we test and develop various manufacturing concepts to further improve API synthesis. We offer rapid scale-up from the lab phase with manufacturing up to pilot scale – and of course seamless transfer to our sister facility in Linz…

Regensburg (ResCom®)

Our services here focus on fast supply of clinical trials materials (cGMP as well as nonGMP) and includes the development/implementation of chemical processes based on drug discovery or more advanced procedures. Included in ResCom’s offering is the performance of stability studies, support for customers in registration activities (eg, support in CMC-section), and many more services needed for the advancement of new investigational APIs through the development pipeline.

ResCom® is also key for piloting new technologies in the chirality-field (access to enantiomerically pure compounds), and was invented at DSM’s central research in Geleen. Our strong and innovative technologies help develop and produce various chiral building blocks needed for efficient drug production.

Linz and Venlo

Our manufacturing sites in Linz and Venlo are outstanding facilities that provide fast, efficient and flexible commercial manufacturing of APIs and intermediates under full cGMP conditions. 

They offer a wide range of technologies that can be tailored for the unique needs of our customers. This includes innovative micro reactor technology, which enables our customers to improve the throughput of chemical reactions, not only increasing speed and efficiency, but doing it more sustainably.

This bright science is delivered by an outstanding team, supported by comprehensive quality systems across the entire supply chain; and unparalleled regulatory expertise and compliance – all of which makes Linz and Venlo proven facilities you can trust. 

We service customers through our facility in Groningen in the Netherlands; and a new plant in Brisbane, Australia…

Groningen

From pre-clinical development to commercial supply, our mammalian manufacturing facility in Groningen in the Netherlands has been the premier CMO site for hundreds of successful biopharmaceutical projects. With flexible capacity and an impeccable regulatory track record, we focus on the development, scale-up, and cGMP manufacturing of recombinant proteins and antibodies.

Groningen offers an annual capacity output of 200+kg using fed-batch, perfusion, and/or our own high-yield XD® technology, complemented by a 1860 m2 process development area and a 1860 m2 cGMP area: The facility also includes four independent bioreactor suites with single-use bioreactors up to 1000L and stainless steel bioreactors up to 250L.

We offer downstream processing output of up to 5kg/batch using single-use clarification systems up to 80 m2; concentration for perfusion harvest, and/or our revolutionary RHOBUST® technology. 

Brisbane

We continue to invest significantly in supporting the future needs of the biopharmaceutical industry.  Always at the cutting-edge of innovation, our mammalian manufacturing facilities provide the most flexible solutions for customers with biosimilars and novel biopharmaceutical products. 

In mid-2013 we open a state-of-the-art mammalian cGMP manufacturing facility in Brisbane, Australia with an 8000m2 area. The new facility represents a partnership between DSM and BioPharmaceuticals Australia (funded by the Queensland Government) and will provide process development, (pre)clinical and commercial manufacturing operations based on our unmatched expertise, flexibility and innovative technologies.

  • Capacity output up to 500 kg/year
  • Significant tax incentives granting up to 45% return for development programs performed in Australia
  • 100% single use upstream processing equipment up to:
    • 2000L Fed-batch
    • 500L XD® Technology, replacing large scale bioreactor sizes for commercial manufacturing
    • 250L Perfusion
  • Three separate downstream processing suites
    • Hybrid single/multiple use DSP equipment
    • RHOBUST® one step direct capture downstream technology.

Design Philosophy

Our Brisbane facility has been designed to provide a unique blend of sustainability, flexibility, modular unit operations, single-use technology; and all while meeting future regulatory expectations.  In particular the facility offers:

  • Reduced risk of contamination
  • Reduced preparation and cleaning/sterilization validation
  • Faster batch turnaround times
  • Adaptability to client needs and unique processes
  • Ability to evolve with future innovations
  • Smaller footprint with an open-plan approach
  • Entirely single-use USP equipment including dispensing operations through to buffer and media make-up, solution filtering, storage and transfer, cell culture vessels and cell harvest (depth filtration)
  • Hybrid single/multiple use DSP equipment
  • Separate personnel and materials transfer areas
  • Lower water and energy consumption and reduced waste
  • Future expansion capability (with a ready-built floor ready for outfitting to customer’s requirements).

Our primary plant in Capua, Italy produces the safest, highest-quality products – consistently and at high volume. This is supported by some four decades of regulatory excellence, all of which enables us to achieve an accurate and competitive cost of goods for all our customers.

At Capua we operate multiple fermenters ranging from 35 m3 to a massive 100 m3. This includes several different downstream processing facilities, dedicated exclusively to cGMP manufacturing. 

The facility also produces both oral and injectable APIs and features unit operations covering virtually all requested applications for batch recovery from intra- and extra-cellular products.

Our pharmaceutical dosage form manufacturing is based in Greenville, North Carolina and offers our customers unmatched quality and reliability supported by an outstanding regulatory record.

This 1.5 million square foot facility includes 29 buildings on a 640-acre site, manufacturing aseptic liquid fill and lyophilized products and oral dosage forms, along with related services.

We support all this with state-of-the-art technology, from production and quality processes to project management systems and regulatory support. In fact, some 90% of pre-approval inspections (PAIs) from the FDA have been waived over a three-year period. 

We currently fill two of the market’s top five biotech products and repeated launch 10 or more products every year – all of which makes DSM a partner you can truly trust.

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