- Andelyn Biosciences and PQP Group have formed a strategic partnership to support sponsors supplying cell and gene therapy products to clinical sites in the European Union and the United Kingdom.
- The partnership combines Andelyn’s development, manufacturing, quality, and supply chain capabilities with PQP’s Qualified Person (QP), import, certification, and distribution services.
Andelyn Biosciences and PQP Group have announced a strategic partnership to establish a coordinated pathway for supplying cell and gene therapy products from the United States to clinical sites in the European Union (EU) and the United Kingdom (UK). The collaboration is designed to help sponsors manage the regulatory, import, certification, and distribution requirements associated with clinical supply in these markets.
Under the partnership, Andelyn will integrate its development, manufacturing, quality, and supply chain capabilities with PQP’s regional services. These include QP audit reports and declarations, Product Specification File (PSF) creation, Investigational Medicinal Product Dossier (IMPD) and batch review, batch certification, import arrangements, shipping, depot storage, and distribution support. PQP, headquartered in the UK and the Netherlands, holds Manufacturing and Import Authorizations and provides QP services to support the import and release of medicinal products and clinical trial supply.
The companies said they have completed foundational work to establish a standardized process for clients and sponsors. Andelyn will maintain the primary relationship with the client sponsor and act as the single point of contact throughout project execution. The model is intended to provide a connected supply chain without requiring sponsors to manage additional stakeholders and suppliers.
“Expanding access to reliable clinical supply pathways is an important step toward helping our clients advance life-changing cell and gene therapies globally.”
Matt Niloff, chief commercial officer at Andelyn
Stephan Croft, co-founder and QP at PQP Group, said the partnership combines Andelyn’s cell and gene therapy manufacturing capabilities with PQP’s QP and regional supply chain expertise to support the import, certification, and delivery of clinical materials.
The partnership supports Andelyn’s broader focus on advancing cell and gene therapies from development through clinical and commercial readiness. Both companies will attend the Meeting on the Mesa conference from October 5–8, 2026.
