In today’s dynamic pharmaceutical landscape, Douglas, a New Zealand-based contract development and manufacturing organization (CDMO), has emerged as a standout. As a privately-owned CDMO, Douglas distinguishes itself through its specialization in high-potency softgel and liquid formulations and its commitment to bespoke, client-centric services. This unique positioning is further reinforced by the efficiency and reliability of New Zealand's local regulatory body.
A New Zealand success story
Founded in 1967 in New Zealand by Sir Graeme Douglas, Douglas is now one of New Zealand’s largest privately-owned pharmaceutical companies and a respected name in the global pharmaceutical industry. Douglas handles a range of dosage forms but has built a reputation for its expertise in the development and manufacture of high-potency softgel and liquid formulations. Today, Douglas is a one of the leading suppliers of pharmaceutical softgel products in the U.S. and Europe.
With its research and development facilities located nearby its manufacturing site in Auckland, New Zealand, the company adopts an agile approach that facilitates fast decision-making and collaboration among subject matter experts.
“As a family-owned business we have the flexibility to make quick decisions and adapt to changing market dynamics. We operate with fewer lengthy escalation processes, which are commonplace in larger CDMO companies with more complex ownership structures,” says Jeff Douglas, Managing Director of Douglas CDMO.
Douglas CDMO's Managing Director, Jeff Douglas.
An expert partner in softgel technology and beyond
Douglas has been at the forefront of softgel innovation since the 1990s with a broad portfolio of generic and novel softgel products to its name. Softgel dosage forms have proven popular as their unique composition of a gelatinous shell and liquid or semi-liquid fill can help improve the bioavailability of poorly soluble drugs; they are also considered easier to swallow and visually appealing for consumers.
Says Peter Surman, Chief Scientific Officer at Douglas CDMO, “Factors such as improved oral bioavailability of the drug, improved stability of the drug, and greater market differentiation all play a part in why softgels are a highly advantageous, and increasingly popular dosage form. The oleaginous fill of many softgels aids permeation of the active ingredient through the epithelium of the gut to improve systemic blood levels to reduce pill burden. This is especially relevant for actives that are poorly soluble in water. The body can absorb and utilize the medication more efficiently.”
Douglas’ team has a wealth of experience and has invested heavily in state-of-the-art technology and specialized equipment to enhance the effectiveness and stability of softgel products. Peter points out that the complexity of manufacturing softgels can result in competitors struggling with technical challenges, causing them to drop out of the market.
“The manufacturing of softgels can be difficult, requiring skilled operators and technical experts to ensure consistent product quality. Our competitors often struggle with technical challenges causing them to drop in and out of the market.
Achieving and maintaining the quality and consistency of softgel products is challenging and requires a high level of expertise. At Douglas, we have state-of-the-art facilities and specialized equipment that is critical in maintaining precise control over the formulation and ensuring dosage uniformity and quality across batches. We have invested in technologies such as wet media milling capabilities, enabling us to produce proprietary particle size distributions to tune oral bioavailability and ensure fill precision from the first to the last capsule produced in a batch. Our formulators are skilled in the development of self-emulsifying delivery systems to enhance the bioavailability of poorly soluble drugs, and to facilitate their absorption in the gastrointestinal tract.”
Douglas boasts world-class expertise in developing and manufacturing high-potency softgel and liquid formulations. (Photo: Douglas CDMO)
Douglas selected for FDA’s Quality Management Maturity pilot study
Douglas has been selected as one of nine companies worldwide to participate in the Food and Drug Administration (FDA) Quality Management Maturity (QMM) pilot study. This highlights Douglas’ unwavering commitment to quality and improvement.
“We are delighted to be one of the few companies selected to participate. The QMM program goes beyond good manufacturing practice requirements and aligns with our commitment to delivering excellence at all levels of our organization,” says Beatrijs Van Liedekerke, General Manager of Quality at Douglas CDMO.
The QMM program is voluntary and is designed to assist drug manufacturers in achieving higher levels of quality management maturity at their facilities. By participating, companies will be assessed on their overall quality management systems beyond cGMP requirements and provided with improvement opportunities. The aim is to reduce the occurrence of product quality issues and improve an organization’s ability to maintain performance during unexpected supply chain disruptions.
Rod De Spong, Chief Operating Officer at Douglas CDMO, sees this selection as a pivotal moment. “We are incredibly proud to be involved in this FDA-led initiative to address the issue of drug supply shortages. This presents an invaluable opportunity to further enhance our quality and operational practices to benefit our CDMO clients, partners, and end customers.”
Douglas has been selected as one of nine companies wordwide to participate in the Food and Drug Administration (FDA) Quality Management Maturity (QMM) pilot study. (Photo: Douglas CDMO)
People, purpose, and progress
Douglas fosters long-term partnerships built on trust, collaboration, and mutual success. The company has a client-centric approach, which permeates every aspect of operations, from project management to customer support. Jeff Douglas, Managing Director at Douglas CDMO, notes how the company continuously seeks opportunities to enhance its capabilities, improve processes, and explore solutions that drive value for clients.
By investing in cutting-edge technologies and nurturing a culture of continuous learning and development, he states, “We give our clients our 100% commitment, and that’s something they can expect from us. We have a learning mindset. We are always willing to find ways to problem solve and innovate.”
New Zealand – a uniquely advantageous place for product development
Due to the efficiency of its regulatory and clinical trial research processes, New Zealand offers an advantageous environment for pharmaceutical drug development. By developing formulations and conducting clinical trials in New Zealand, companies can benefit from robust but streamlined processes to potentially accelerate time to market.
“A company, in theory, can get into first-in-human trials much quicker here in New Zealand than in the U.S. In the U.S., a Pre-Investigational Drug (IND) submission is required for a first-in-human trial, which isn’t required in New Zealand. There is the potential for considerable time savings for companies looking to initiate their first-in-human trials here,” notes Rhona Macdonald, Head of Clinical Research at Douglas CDMO.
Douglas’ location in New Zealand also provides strategic advantages for U.S. and European partners. The time zone difference enables global partners to hand over tasks or issues at the close of their workday, facilitating a nearly 24-hour operational cycle. This arrangement can significantly accelerate project timelines and potentially reduce time to market.
An effective CDMO partner
Through its pursuit of innovation, together with its investment in its people and infrastructure, Douglas has shown that geographical location is no barrier to global impact on the CDMO stage. By combining family-owned business values with specialized expertise, personalized service and a drive for quality, the future of contract manufacturing might just have a distinctly “Kiwi” flavor.
Learn more at www.douglascdmo.com
