Smooth Connection — Custom manufacturing isn't as easy as filling an order and calling it a day. The gears that interlink a CMO and its customer have to be well oiled and a perfect fit. This is nothing new to Laura Parks, President of DSM Pharmaceuticals, the finished dosage business of DSM Pharmaceutical Products, who says building solid relationships with customers is the basis for delivering on promises, both to clients and to the end user, the patient. Brandi Schuster spoke to Parks about the challenges facing CMOs today and how DSM drives innovation.

CHEManager Europe: How do you think the role of a CMO has changed over the years?
Laura Parks: Over the last several years, companies have really become ready to embrace third-party outsourcing and the flexibility that comes with it. Some companies have definitely made this their philosophy in a big way. Companies have also come to recognize the advantages of having an outside view of how their processes work and how perhaps some workflows can be tweaked or optimized.

Would you say that the CMO business has really picked up over the last couple of years?
Laura Parks: Yes, it continues to grow. Several large pharma companies have made it clear that outsourcing is a very important part of their strategy. On the other side, there will always be companies who decide that operational excellence and doing their own manufacturing is important. And, of course, there are companies who are slowly moving into working with CMOs. In effect, there are companies who have really worked hard to develop competencies in working strategically with CMOs while others are still working on what such a relationship could look like.

What do you see to be the biggest trend right now in custom manufacturing?
Laura Parks: People need the reliability of supply, and this is really where the focus has been. Companies are asking themselves how they can work more closely with CMOs in order to ensure the security of supply. This leads into leading-edge trends of systems that provide real-time data from manufacturing facilities so they can proactively avoid issues that could possible affect reliability down the line.

What about the ever-changing regulatory landscape?
Laura Parks: The regulatory environment in the U.S. has been significantly more challenging in the last couple of years. The U.S. Food and Drug Administration expects the working relationship between CMOs and their customers to be a close one. For us, it means figuring out how to have as seamless of a relationship as possible with our customers and be united in our philosophy and our approach for the regulatory agencies. They want to see us working together, and they need to be assured that we are doing the right thing for patients.

What does DSM do to actively head up such challenges?
Laura Parks: One of the biggest challenges facing our customers is simply the lack of predictably as to which drugs will make it all the way through the pipeline to commercialization. It's our job to be ready to turn it on or turn it off, so to speak, depending on what happens on a regulatory basis. This is why it is absolutely key for us to have a strong working relationship with our clients; it is much easier to react quickly when a healthy working relationship is already in place. It takes much long to react if the relationship has not yet really been developed.

How does DSM Pharma drive innovation as a CMO?
Laura Parks: Engaging our people is one of the most important things we can do in the pharma industry because of the huge impact we have on patients. In this industry, the workforce has to be as engaged as possible. That means making sure our employees understand the impact of what they do every day, having them involved in making the business more successful  and getting them involved in problem solving and continuous improvement.

DSM recently opened a new cGMP facility in Brisbane, Australia; it's the first custom mammalian-based biopharmaceutical manufacturing operation in country. How important is biopharma in Asia-Pacific?
Laura Parks: Right now, the biggest markets for biopharma at the moment are still the U.S., Europe and Japan. However, there is a very large market in Asia-Pacific, and we are seeing more and more investments in the region, in this case to serve the immediate needs of Australian biopharma. Opening this facility is another example of how we drive innovation at DSM; it's really the kind of plant that we'll see more of in the future. There's a lot less stainless steel, more disposable components, which offers us more flexibility.

And how does the facility stack up against Asian CMOs who are already there in the region?
Laura Parks: It's a brand new cGMP plant with an entirely new design for process development through to commercial manufacturing mammalian cell culture work; it's our 'biologics plant of the future'. It's a pristine facility offering both standard technologies and our portfolio of proprietary technologies that we think will be very competitive in the region.

What about other regions of the world that are of heightened interest for DSM in terms of contract manufacturing?
Laura Parks: For the foreseeable future we will continue to expect the North American, European and Japanese markets to continue to be the highest profitability markets. We are also looking to our growth in Asia, specifically in India and China.   

Regardless of where we are located, it is essential to understand the difference in the expectations of customers and patients in other markets. For example, our finished dosage CMO business is based in the U.S., but when we supply to Japan, there is certainly a different expectation as to what quality is acceptable.

Is there something that would be a completely normal finished dose in America which would be unacceptable for the Japanese market?
Laura Parks: Things that would be considered a simple cosmetic defect in the U.S., such as a small scratch on a vial, would be considered unacceptable in Japan. That's why it's important to understand no only the customers' needs, but also their customers' needs as well.

Visit DSM at the CPhI 2013 in Frankfurt Oct. 22-24 in hall 3, booth A32.