Founded in New Zealand in 1967, Douglas CDMO has since expanded into a strategic contract manufacturing and development organization (CDMO) partner that collaborates with pharmaceutical, biotechnology and life science companies around the world to achieve their competitive advantages.

Clients trust Douglas CDMO as a partner for its commitment to quality, transparency, and a seamless experience. The company has a proven track-record in offering end-to-end integrated drug development services, specializing in formulating and commercially supplying innovative and generic high-potency small molecule softgels and liquids. Its capabilities extend to producing prescription drugs across key therapeutic areas, including dermatology, oncology, endocrinology and the central nervous system.

In this Q&A, Susan Lynch-Smith, Head of Business Development for Douglas CDMO, discusses the benefits of working with a boutique CDMO, especially how it impacts client relationships, agility, flexibility, project management and decision-making—as well as the company’s unique tailored approach.

Contract Pharma: What are the primary distinctions between collaborating with a boutique CDMO and working with a large CDMO?

Susan Lynch-Smith: When most people hear “boutique” they might think small, narrower range of capabilities and restricted volumes – but the fundamental differences between boutique and large CDMOs is less about manufacturing capacity and more about the number of projects they take on.

Boutique CDMOs like Douglas CDMO prioritize building deep, collaborative relationships with our clients, understanding their unique needs and tailoring solutions accordingly. We excel in agility, personalized attention, and focused expertise. Large CDMOs, handling numerous projects simultaneously, often struggle to provide the same level of individualized service.

Another key difference is in project management. Large CDMOs often operate with rigid, standardized processes, which can hinder flexibility and responsiveness. Boutique CDMOs can adapt quickly to changing project requirements and client feedback. Decision making is typically faster and more direct in a boutique environment, as there are fewer layers of bureaucracy.

CP: What advantages does a boutique CDMO offer in terms of speed and flexibility, particularly in adapting to unexpected changes in a project?

Lynch-Smith: Douglas CDMO thrives on its agility and flexibility, providing clients with a significant advantage in today’s dynamic pharmaceutical landscape. Our smaller size and streamlined operational structure allow us to react swiftly to unexpected changes, ensuring project timelines remain on track. In contrast to larger CDMOs, where bureaucratic processes can slow down decision-making, we can adapt rapidly to new data, revised protocols, or unexpected challenges.

Moreover, our size allows us to be more adaptable in resource allocation. We can reallocate personnel and equipment as needed, ensuring projects remain efficiently managed. This level of flexibility is crucial in the pharmaceutical industry, where projects are often complex and subject to change.

Douglas CDMO has the additional benefit of being a privately owned, family-run company. This translates to quicker problem-solving and smoother project progression.

At Douglas CDMO, we understand that adaptability is not just a benefit; it’s a necessity. We are committed to providing our clients with the responsiveness and agility they need to navigate the complexities of drug development to commercial manufacturing.

CP: How does a boutique CDMO’s decision-making process differ from that of a larger organization, and how does this translate to faster problem-solving and project progression?

Lynch-Smith: The decision-making process at Douglas CDMO is fundamentally different from that of larger organizations. Our streamlined structure and flat hierarchy enable rapid decision-making, which translates to faster problem-solving and project progression. In larger CDMOs, decisions often require multiple layers of approval, leading to delays and inefficiencies. At Douglas CDMO, our key decision-makers are directly involved in project oversight, allowing for immediate action.

Furthermore, our close client relationships foster a collaborative environment where decisions are made with a deep understanding of the client’s needs and objectives. This personalized approach ensures that solutions are not only efficient but also tailored to the specific requirements of each project. We prioritize clear and direct communication, ensuring that clients are always informed and involved in the decision-making process. This transparency builds trust and strengthens our collaborative partnerships.

CP: What technologies and services does Douglas CDMO offer to help its clients achieve their goals?

Lynch-Smith: Douglas CDMO offers a comprehensive suite of technologies and services designed to support our clients from early-stage development through commercial manufacturing. Our expertise spans a wide range of pharmaceutical development and manufacturing activities, tailored to meet the unique needs of each project for soft gels and liquids.

We specialize in process development, analytical development, and formulation development, leveraging state-of-the-art technologies and methodologies. Our advanced analytical capabilities ensure the quality and consistency of our clients’ products. We also offer comprehensive manufacturing services, including small-scale and pilot-scale production, allowing clients to efficiently scale up their processes through commercialization, along with packaging and distribution to over 40 countries.

We also offer specific services in areas like high potency API handling, and specialized formulation development. We focus on providing solutions that are right sized to our clients’ needs and ensure that our tech transfer and scale-up processes are seamless.

Our goal is to be a trusted partner for our clients, providing them with the tools and expertise they need to achieve their development and manufacturing goals efficiently and effectively.

CP: How do you address the perception that larger CDMOs have more resources and therefore less risk than smaller CDMOs?

Lynch-Smith: We believe this perception often overlooks the advantages of our boutique approach.

We mitigate risk through our specialized expertise, robust quality management system, and proactive communication. Our focused approach allows us to allocate resources efficiently and effectively, ensuring projects are managed with precision. We prioritize building strong, collaborative relationships with our clients, fostering trust and transparency, and this formula of success has worked for over 57 years and counting.

In addition, we  focus on risk mitigation through detailed project planning and proactive problem-solving. Our streamlined decision-making process allows us to address potential risks quickly and efficiently. We believe that our combination of expertise, agility, and personalized service provides a level of risk mitigation that is often unmatched by larger CDMOs.

CP: What are the most common misconceptions clients have about working with a boutique CDMO, and how do you address them?

Lynch-Smith: Common misconceptions about boutique CDMOs often revolve around concerns about capacity, resources, and long-term stability. Clients may worry that smaller CDMOs lack the infrastructure and financial backing to handle complex projects or ensure long-term partnerships. At Douglas CDMO, we address these concerns through transparent communication and tangible demonstrations of our capabilities.

We highlight our state-of-the-art facilities, experienced team, and robust quality management system to alleviate concerns about capacity and resources. We provide detailed project plans and timelines, demonstrating our ability to manage complex projects efficiently. We also highlight our financial stability and long-term commitment to our clients.

Douglas CDMO prioritizes clear and transparent communication, ensuring our clients are always informed and involved in the project. We believe that building trust and demonstrating our commitment to long-term partnerships is crucial in overcoming these misconceptions.

CP: What specific types of projects and project sizes are your ideal fit, and what are your limitations?

Lynch-Smith: Douglas CDMO excels in softgel and liquid projects that require specialized expertise, agility, and personalized attention. Our ideal projects include early-stage development, formulation development, analytical development, and small to medium-scale manufacturing. We are particularly well-suited for projects involving complex molecules, high-potency APIs, and niche formulations.

Our size allows us to be highly flexible and responsive, making us an ideal partner for projects that require rapid turnaround times and frequent adjustments. We thrive in collaborative environments where we can work closely with our clients to achieve their goals.

We focus on providing right-sized solutions, ensuring that our clients receive the personalized attention and specialized expertise they need.

We are transparent about our capabilities and limitations, ensuring that our clients have a clear understanding of what we can offer.

CP: How do you ensure a tailored approach for each client?

Lynch-Smith: At Douglas CDMO, we understand that each client and project is unique. We ensure a tailored approach through personalized communication, in-depth project planning, and flexible solutions. We begin by conducting thorough consultations to understand our clients’ specific needs and objectives. We then develop detailed project plans that are customized to meet the unique requirements of each project.

We maintain close communication throughout the project, providing regular updates and seeking feedback to ensure alignment with our clients’ expectations. Our team of experienced scientists and engineers works collaboratively with our clients, adapting our processes and solutions as needed.

We prioritize flexibility, allowing us to adjust our approach based on evolving project requirements. This adaptability is crucial in the pharmaceutical industry, where projects are often subject to change. We understand that a one-size-fits-all approach is rarely effective, and we strive to provide solutions that are tailored to the specific needs of each client.

Furthermore, we invest in understanding our clients’ long-term goals and strategic objectives. This allows us to provide insights and recommendations that go beyond the immediate project scope. We aim to be a trusted partner, providing comprehensive support that aligns with our clients’ overall business objectives.

CP: What are Douglas CDMO’s plans for the future?

Lynch-Smith: Douglas CDMO’s plans center on strategic growth and continuous improvement, ensuring we remain a leading boutique CDMO specializing as an end-to-end provider taking projects at the development stage and getting them to commercial success for both softgels and liquids. We aim to expand our specialized service offerings, focusing on emerging technologies and innovative solutions that address the evolving needs of the pharmaceutical industry.

We are also focused on sustainable growth, exploring opportunities to expand our facilities and resources while maintaining our commitment to environmental responsibility.

We will also explore strategic partnerships and collaborations that align with our growth objectives.

Our goal is to solidify our position as a trusted and reliable partner for pharmaceutical companies seeking specialized CDMO services for softgels and liquids. We will continue to build upon our core strengths of agility, expertise, and personalized service, ensuring that we deliver exceptional value to our clients.