Supplying pharmaceutical products into specialised channels within the United States (US) market presents unique manufacturing and regulatory requirements. For one multinational pharmaceutical company, supplying a commercial-stage small molecule softgel product into the US market required a Trade Agreements Act-compliant manufacturing site.
The programme involved transferring an established manufacturing process without modification, introducing new technologies and integrating manufacturing and packaging capabilities.
Why Douglas CDMO stood out in a highly competitive global search
The multinational pharmaceutical company evaluated manufacturing partners around the world before selecting Douglas. Douglas’ integrated single-site model and strong experience supporting products for the US market were key factors in the client’s decision.
As Lora Wallis, Head of Delivery – Pharma at Douglas, explains, “Many contract manufacturers will only undertake the manufacturing operation, requiring clients to engage additional partners for packaging. Being able to provide those capabilities from a single site, supported by our long-standing softgel expertise, was an advantage.”
“Softgels are not a straightforward platform. Having people who have worked in this area for decades means we can often anticipate potential challenges and identify practical solutions before work even begins.”
Lora Wallis, Head of Delivery
Lora believes the company’s culture and way of working were also important differentiators.
“We work hard to understand what is important to our clients and stay focused on helping them achieve their objectives. That means being responsive, communicating openly and doing everything we can to help our clients achieve their goals and milestones.”
Executing a complex technical transfer at speed
To support the client’s regulatory submission strategy, the manufacturing process in New Zealand needed to replicate the process already established at the existing manufacturing site. With little flexibility to modify critical aspects of the registered process, Douglas implemented a highly controlled transfer programme to ensure alignment while successfully transferring production to Douglas’ New Zealand facility.
The programme needed to be completed within an ambitious timeframe. For Lora, the scale of what was required became apparent early on.
“Twelve months would have been an aggressive timeline even without needing to procure six new assets. We were introducing new equipment and new technologies while progressing the transfer and preparing our facility to support the project.”
The programme required Douglas to procure, install and qualify six new assets to replicate the client’s established manufacturing process. Despite careful planning, one critical piece of equipment arrived five months late and in a damaged condition, just weeks before manufacturing activities were scheduled to begin. The team needed to adapt quickly and implement practical solutions to maintain momentum and keep the programme on track.
Despite the ambitious timeline and delays in receiving equipment, the programme maintained momentum across key workstreams, including equipment qualification, QC method transfer and registration batch manufacture. Progress across these workstreams enabled registration batches to be manufactured as planned and stability data to be generated in line with the client’s submission timelines.
As Lora notes, “The programme presented challenges, as complex transfers always do, but close coordination across both organisations helped us respond quickly and maintain progress.”
Building momentum through partnership and direct access to experts
The aggressive timelines of the programme meant close collaboration between both organisations was essential from the outset. Teams from the multinational pharmaceutical company visited New Zealand regularly, including during critical phases of the technical transfer.
As Lora explains, “These visits were always valuable because they allowed our teams to build relationships, exchange knowledge and develop trust. That makes a real difference when you’re working through a complex and timebound programme together.”
Direct access to subject matter experts and regular communication enabled decisions to be made quickly and kept both organisations focused on the same objective.
“Regular communication was incredibly important throughout the programme. It kept both organisations aligned and meant we could bring the right people together quickly whenever decisions were needed.”
Lora Wallis, Head of Delivery
Reflecting on the programme, Lora says, “This project showed what an experienced, integrated team can achieve. Technical capability is essential, but so is agility, collaboration and maintaining a clear focus on the client’s objectives to help them succeed.”