When a Japanese biotech company needed to scale production for US clinical trials, they didn’t just need a manufacturing partner—they needed a global strategy. That’s where Venn Life Sciences stepped in, navigating complex regulatory requirements, cultural barriers, and technical challenges to deliver a seamless CDMO transition from Europe to China. The result: FDA approval, uninterrupted clinical trial supply, and a long-term partnership built on trust and expertise.
Biopharmaceutical companies often face critical bottlenecks when scaling up production for clinical trials, especially when existing CDMOs fall short on capacity or cost-efficiency. Venn Life Sciences, a trusted development consultancy, stepped in to assist a long-standing Japanese biotech client in identifying and onboarding a new CDMO partner for their US-based trial. Drawing on years of collaboration, Venn had already established a strong working relationship with the client, having supported them across CMC, non-clinical, and clinical development. Their evolving role made them a natural choice to lead this pivotal transition.
When the client’s European CDMO could no longer meet scale demands or budget constraints, Venn initiated a global search, shortlisting eight CDMOs from Europe, the US, India, and China. With a meticulous assessment process led by Erik Gout and Azra Gholami, the list was narrowed to three based on cost, communication efficiency, and technical capacity. China’s time zone alignment and cost advantage made it the client’s preferred destination—provided regulatory standards and FDA requirements could be met.
Venn ensured the new CDMO had the right technical infrastructure and adhered to quality standards for both the US and EU markets. A customised evaluation framework guided the process, involving detailed technical queries and a comprehensive checklist prioritised by the client and Venn’s consultants. The selection process didn’t stop at the boardroom—Venn travelled to China with the client for on-site technical meetings, quality audits, and direct employee training, reinforcing their commitment to quality and hands-on problem-solving.
One of the most critical moments came when trained staff at the chosen CDMO were unexpectedly reassigned. Azra quickly identified the disruption, escalated the issue, and helped the client reinstate the original team. This swift intervention ensured continuity in analytical processes and avoided regulatory or timeline setbacks.
Despite the complexity of cross-continental technology transfer and communication challenges, Venn’s strategy delivered success. The FDA approved the CDMO’s filing, and the drug product is now in full clinical supply without disruption. Venn continues to manage the CDMO relationship, maintaining operational harmony and regulatory compliance.
Venn Life Sciences is a European drug development consultancy offering tailored support across Chemistry, Manufacturing, and Controls (CMC), clinical development, and regulatory strategy—empowering biotech companies to navigate complex development stages with confidence.
hVIVO plc (formerly Open Orphan plc), led by Cathal Friel, is a rapidly growing specialist contract research organisation (CRO) and the world leader in testing infectious and respiratory disease vaccines and antivirals using human challenge clinical trials, providing end-to-end early clinical development services for its broad and long-standing client base of biopharma companies.
