Andelyn Biosciences, PQP Partner to Streamline EU and UK Supply for CGT Sponsors

Editor’s take: With the increasing complexity of CGT programs, sponsors are focusing on strategic partnerships to expand their offerings.

Andelyn Biosciences, a US-based cell and gene therapy CDMO, and PQP Group entered a strategic partnership to expand support for sponsors supplying cell and gene therapy products to clinical sites in the EU and UK. 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.

The relationship establishes a standard process to support sponsors in these regions. Andelyn and PQP have completed foundational work designed to enable an efficient 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 aim to provide sponsors with a more coordinated pathway to bring clinical and commercial gene therapy materials from the U.S. 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.”