Andelyn Biosciences (“Andelyn”), a leading US-based patient-focused cell and gene therapy Contract Development and Manufacturing Organization (“CDMO”), and PQP Group announced a strategic partnership.
PQP, headquartered in the UK and the Netherlands, holds Manufacturing and Import Authorizations and provides Qualified Person (QP) services that enable clients to import and release medicinal products from outside these territories, supporting Clinical Trial Authorizations (CTAs) and related supply.
Through the partnership, Andelyn and PQP are expanding support for sponsors supplying cell and gene therapy products to clinical sites in the EU and UK. The relationship establishes a standard process to support sponsors in these regions. Andelyn and PQP have completed foundational work to enable an efficient, nimble, and well-defined process for clients and sponsors.
This framework integrates Andelyn’s development, manufacturing, quality, and supply chain capabilities with PQP’s services, including QP audit reports, QP declarations, Product Specification File (PSF) creation, Investigational Medicinal Product Dossier (IMPD) and batch review, batch certification, import and shipping services (importer of record, broker, import license, and depot storage), and distribution support.
Together, Andelyn and PQP are providing sponsors with a more coordinated pathway to bring clinical and commercial gene therapy materials from the United States into the EU and the UK.
“Expanding access to reliable clinical supply pathways is an important step toward helping our clients advance life-changing cell and gene therapies globally,” said Matt Niloff, CCO at Andelyn. “Through this relationship with PQP Group, we are supporting sponsors with an integrated approach that combines Andelyn’s manufacturing and quality capabilities with specialized EU and UK QP, import, and distribution expertise.”
“PQP is pleased to partner with Andelyn to provide a coordinated clinical supply offering for sponsors advancing innovative therapies into the EU and UK,” said Stephan Croft, Co-founder and QP at PQP Group. “By combining Andelyn’s established cell and gene therapy manufacturing capabilities with PQP’s QP and regional supply-chain expertise, we are helping sponsors navigate critical steps in importing, certifying, and delivering clinical material.”
Andelyn maintains the lead relationship with the client sponsor and serves as the single point of contact throughout project execution. This model gives sponsors access to a connected supply-chain solution without requiring them to manage additional stakeholders and suppliers.
This relationship reflects Andelyn’s broader mission to advance cell and gene therapies from development through clinical and commercial readiness. With its end-to-end capabilities, rigorous quality systems, and patient-focused approach, Andelyn helps organizations bring critical therapies to patients worldwide.
