A Look Ahead at Manufacturing and Regulation - Pharmaceutical Technology

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A Look Ahead at Manufacturing and Regulation
FDA talks about the changing scope of regulatory science and its effect on drug reviews, site inspections, overall approaches.


Pharmaceutical Technology Europe


Where are CMOs headed? A Q&A with DSM Pharmaceutical Products CEO Alexander Wessels by Angie Drakulich


DSM Pharmaceutical Products CEO Alexander Wessels
DSM Pharmaceutical Products received an award for best CMO in the summer of 2013 from the second annual BioPharma Asia Industry Awards in Singapore. Pharmaceutical Technology Europe discussed industry trends in pharmaceutical outsourcing with DSM Pharmaceutical Products CEO Alexander Wessels.

PTE: In your experience, what capabilities are CMOs now expected to have that they didn't have 5 or 10 years ago?

Wessels: DSM's stake in the pharma outsourcing market is based on a global portfolio of resources to continuously serve changing customer needs and bring real value as the pharma industry shifts business models. This requires a breadth and depth of expertise in the various areas of pharmaceutical technology that can be applied to customer challenges for increasingly efficient processes. We are embedding such innovations across our mammalian, microbial, chemical and finished dosage platforms. In the area of process analytical technology (PAT), for example, DSM has demonstrated the efficiencies and safety of microreactor technology for the commercialscale production of APIs as an example of process intensification to achieve more efficient commercial production, better manage manufacturing volumes and drive down total costs. In this way, we can challenge current process technologies with innovations in process intensification for next-generation manufacturing solutions.

PTE: What is your view on industry consolidation and where do you think this will lead the CMO sector?

Wessels: Some sectors of the CMO market experience more pressure than others; biopharma growth is still high while consolidation in the API sector, particularly in the Western countries, is something that we see happening as lower growth rates for innovative drugs balance out with generics. Increased competition in this space is intense in both an East versus West perspective, as well as where CMOs can bring cost-effective, sustainable and reliable solutions to the table in any market region. I think that it is important to note that consolidation is being forced not only from a sustainable capacity perspective, but also for reasons of quality and safety.

Our global supply chains are expanding and the safety of ingredients and finished drugs has become critical as outsourcing resources, new and old, are tested. The increase in warning letters being issued clearly indicates a growing concern from a regulatory perspective. At DSM, we are extremely sensitive to this accountability in manufacturing.

PTE: What trends and topics do you expect to see on the pharmaceutical CMO industry's radar in the year ahead?

Wessels: It has become critically clear that quality and reliability are fundamental to CMO performance and will come to bear in balancing out providers across the global regions in terms of consolidation and alliances. DSM has a worldwide organisation 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 organisation enables us to support and advise our customers on a broad range of regulatory questions; ultimately assuring quality and reliability.

Additionally, the sustainability of CMOs themselves is a key issue. At DSM, 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. 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.

Indeed, we are crossing into shared markets in generics where we can achieve new synergies with pharma in meeting demand and driving growth. This applies as well to biosimilars/biobetters, where we can offer collaboration and asset management and optimisation via our proprietary manufacturing technologies.


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