Pharmaceutical Manufacturing asked the following question to four CMOs: The contract development and manufacturing landscape has changed radically, with the addition of biopharma, virtual companies, niched markets and generics manufacturing. What skills are needed for any contract partner to compete, and be successful, in such a fragmented and challenging market?
Peter Soelkner, Managing Director, Vetter: “Many companies have been using the term ‘CDMO’ to define their business model as it suggests that they can help their customers maximize the potential of their compound from the earliest stages of drug development through to commercialization. But a CMO cannot claim to be a CDMO simply because they work on both the development and the manufacturing side of parenterals with their customers. With, on the one hand, ever-increasing regulations as well as constantly high product quality requested; and on the other, a strong focus on controlling and optimizing costs on the customer side, CDMOs have an ever greater need to focus on the ultimate goal: adding value all along the customer product’s lifecycle. The following six skills are crucial for a contractor partner to compete:
Experience: Ask the prospective contract partner questions such as how long the CDMO has been in business and what is their experience with complex compounds. Is integrated drug development and commercial manufacturing part of its portfolio? A strong knowledge of regulations as well as good working relationships with regulators are as important as having a well-trained team. Finding a CDMO outfitted with experienced project managers who understand their business is essential so that each project is handled properly and that communication channels remain open. Proper documentation of processes and the establishment of joint performance measures that can be easily quantified using objective date will be critical to success.
Meeting international quality standards: Providing high-quality yield of valuable product is the goal. Achieving this goal requires a partner that stays abreast of new regulations and meets ever-increasing quality standards. Investigate whether the CDMO is making continuous investments in the technology of its facilities to enable it to remain cutting edge.
Creativity and flexibility: New drugs are subject to many changes, as dictated by results of clinical testing. Creative and nimble approaches to updating project specifications are essential, combined with the flexibility to address the changing needs of the market. Select a dedicated team that can act quickly and proactively at each stage of drug development.
Integrated project approach for long-term partnership: It is critical to employ a continuous partnering relationship. This can be achieved via a key account management philosophy serving as the core element in a company’s strategy to support customer products move efficiently from early drug development through to long-term commercial manufacturing. This process helps result in an integrated approach to projects and the best possible outcomes.
Financial stability: Because a single drug can take years to travel from clinic to marketplace, drug development is expensive. So be certain that your partner can demonstrate solid financial standing. A company with a history of consistent organic growth will prove to be not only a strong partner, but also a strong ally.
Share the vision: Differences in corporate culture and business models are just a few of the issues that can strain a young relationship and threaten positive outcomes. Enable common future success by partnering with a company that makes communication and a shared vision top priority.
Today, being a trusted and well-respected CDMO requires always being there for your customer throughout all stages of its drug’s development and lifecycle, providing necessary support at all times. This will provide the customer with valuable time and resources to concentrate on research and development as well as the marketing of its products.”
Paul Skultety, Ph.D., Director Pharmaceutical Development, Xcelience: “Choosing a good CMO in today’s fragmented market doesn’t have to be hard. Reputation is essential; ask around. There are a few companies out there that will promise the world and don’t deliver. Your colleagues in the industry can help you weed them out. Once you’ve developed a short list, evaluate the CMO on the following five criteria. A good CMO will:
Tell you its strengths: No one company can be expert in all areas of formulation development and analytical work. It’s simply not possible. A good CMO will be up front with you about its strengths and weaknesses. At Xcelience, if we are asked to work in an area where we lack expertise — such as hot melt extrusion, or spray drying — we will contract with an industry-leading expert in that area, rather than try to sell that capability and risk lowering our standards for quality.
Be flexible: Even with the best planning, a good CMO expects the unexpected. Client needs change; sometimes without warning. This could include such things as changing the strengths at the last minute, or changing the number of tablets needed for the study. In one recent case, our client was going to be late delivering their API and would miss the scheduled time for clinical manufacture. We moved up another client’s manufacture of clinical supplies and pushed back the time slot for when the API would arrive, making both clients happy. We are also flexible in working with clients who like to help design formulation development studies as well as with clients who prefer to leave everything up to us.