1. In your particular realm of biologics manufacturing services, what are your biggest challenges in general and how are you working to overcome these challenges?
The industry trends we are seeing ask for flexible and cost-effective manufacturing facilities and processes. DSM Biologics’ answers to these challenges are technology solutions offered through our CMO services which significantly drive down the costs of biologics manufacturing including operating costs, capital requirements and scale-up risks. These are the same technologies that DSM will install in the biomanufacturing facility currently being built in Brisbane, Australia. The Federal Government of Australia and the Queensland Government recognized the benefits of this new ‘biologics plant of the future’ concept and support the construction with grants. The facility will be operational by mid 2013.
2. How is DSM Biologics currently expanding technologies and services to facilitate cost-effective development?
Challenging conventional process technologies with innovation and forward-looking solutions leads us to the next generation of manufacturing processes—leaner and more efficient. DSM’s proprietary upstream and downstream technologies, XD and RHOBUST, result in much lower cost of goods, faster production times and better sustainability by significantly reducing water and energy usage per gram or kilogram of material produced. In combination with developing cutting-edge technologies we are able to offer custom manufacturing services with full flexibility and secured on time supply from our facilities in Europe and Australia.
3. Could you tell us about your main services and capabilities in solid dosage manufacturing?
Our broad capabilities include aseptic filling of liquid and freeze-dried cytotoxic and non-cytotoxic compounds, manufacture of tablets and capsules, pharmaceutical development services, and clinical trial materials manufacturing for solid and injectable forms. At our 1.5M square foot facility in Greenville, North Carolina, DSM offers dosage form manufacturing services for of tablets and capsules at our Greenville, North Carolina site, including the production of instant and sustained-release, and scheduled and non-scheduled drugs. More than 200,000 square feet of our manufacturing capacity is dedicated to solid dosage form manufacturing, which facilitates extensive blending, granulation, compression, encapsulation, coating, drying and formulation capabilities. DSM performs custom manufacturing services for solid dose scheduled drugs in post-discovery or commercial manufacturing phases.
We also offer aseptic liquid filling using a proprietary, flexible, state-of- the-art distributed control system, and lyophilizers that range in size from 8 to 640 square feet. Within our cytotoxic capabilities for filling and lyophilization, we hold Potent Compound Safety Certification from SafeBridge Consultants, Inc.
4. How will DSM broaden its portfolio in terms of products over the next few years?
We are not limiting ourselves to the traditional CMO profile, but becoming a broad pharma partner with an eye on the future of the pharma market from both a supply chain perspective and the need for sustainable manufacturing models to support it. DSM has one of the most diverse CMO and technology positions in the pharma outsourcing space, and with this incredible range of technology and knowledge, we will further grow sales and profits from long-term customer relationships, global supply partnerships, and an expanded portfolio of our own products.
At DSM we are taking a hybrid approach by strengthening our core, and diverse, CMO activities in biotech and traditional API and unique finished dosage production, and balancing our portfolio with activities in biosimilars and generics, involving partners globally, to help them manage their product lifecycles. I would also emphasize that even with fewer NCEs; there is still a critical need for the secure production of proven medicines and new combination drugs as well as NCEs gaining approval.
5. How does DSM’s API division deal with supply chain issues?
As the pharmaceutical industry continues to become more international and global supply chains expand, the safety and traceability of ingredients and finished drugs, as well as the sustainability of these supply chains, become of paramount importance. The almost doubling of the number of warning letters that the FDA has issued this year seems to indicate and address the growing concerns from a regulatory perspective.
I think that it is in this area of quality and reliability that we will see a balancing out of key providers across the global regions, in terms of consolidation and alliances.
Consolidation is also being forced not only from a capacity perspective, but also for reasons of quality and safety, even while becoming truly global. DSM has a world-wide organization of experts in regulatory affairs. These specialists follow changes in local regulations and maintain a close relationship with the relevant local authorities, ensuring that our products always comply with the regulations of the region. This global organization enables us to support and advise our customers on a broad range of regulatory questions, while meeting their supply chain demands.