Andelyn Biosciences And PQP Group Establish EU And UK Supply Pathway For Cell And Gene Therapies
By Elizabeth Urbanek, Executive Editor
Andelyn Biosciences and PQP Group have established a partnership to support sponsors supplying cell and gene therapy products from the United States to clinical sites in the European Union and United Kingdom.
The arrangement combines Andelyn’s development, manufacturing, quality, and supply chain capabilities with PQP’s regional import, Qualified Person (QP), certification, and distribution services. The companies say they have completed the foundational work for a standardized process to support sponsors in these markets.
The goal of the partnership is to give sponsors a coordinated way to manage the steps involved in bringing clinical material into the EU and UK without having to manage additional suppliers independently.
PQP’s services include import licensing, importer-of-record and brokerage services, depot storage, QP audit reports and declarations, Product Specification File creation, Investigational Medicinal Product Dossier (IMPD) and batch review, and batch certification.
Andelyn will maintain the lead relationship with the sponsor and serve as the single point of contact throughout project execution.
Why Clinical Supply Should Care
Getting investigational product to a clinical site takes more than manufacturing and shipping. Import arrangements, product documentation, batch review, and applicable certification requirements must also be addressed before product can reach its destination.
When these activities involve multiple organizations, clinical supply teams need to coordinate responsibilities and timelines across manufacturing, quality, regulatory, and logistics functions. A delay in one area can affect the planned delivery to a site.
Bringing these services together under one sponsor-facing relationship gives teams another way to manage that coordination. For sponsors planning clinical supply across multiple markets, the model offers a single point of contact for activities that must be coordinated before product can reach a site.
The Supply Question
How early should sponsors coordinate import, QP certification, and distribution when planning clinical supply for multiple countries?
Related Clinical Supply Leader Editorial: Managing Customs, Import/Export Requirements, and Cross-Border Logistics Challenges
About The Author:
Elizabeth Urbanek is the Executive Editor for Clinical Supply Leader, where she works with clinical trial supply and logistics professionals across pharma and biotech to bring real-world perspectives, operational challenges, trends, scientific insights and regulatory strategy to the field.
Before joining life sciences media, Elizabeth spent more than 15 years in broadcast, digital and live-event storytelling, helping highly technical teams communicate complex ideas with clarity and impact. She brings that same approach to clinical supply, creating editorial space for experts to share what is happening across clinical trial operations.
Elizabeth is passionate about connecting people and ideas, identifying emerging themes and showcasing work that can move the clinical supply field forward.