IN Brief:
- Andelyn and PQP have established a coordinated route for US-manufactured cell and gene therapy materials entering the UK and EU.
- PQP contributes Manufacturing and Import Authorisations, Qualified Person release, importer-of-record, storage and distribution services.
- Andelyn remains the sponsor-facing lead while the organisations coordinate manufacturing, quality, import and regional supply activity.
Andelyn Biosciences and PQP Group have formed a supply chain partnership intended to give cell and gene therapy sponsors a more coordinated route from US manufacturing into the UK and European Union.
The arrangement combines Andelyn’s development, manufacturing, quality and supply chain capabilities in the United States with PQP’s regulatory authorisations, Qualified Person services, import activity, depot storage and distribution support in the UK and EU. Andelyn will remain the lead relationship for sponsor clients, providing a single point of contact while PQP handles regional functions needed to import and release medicinal products.
PQP holds Manufacturing and Import Authorisations and provides Qualified Person services covering products entering the UK and EU from outside those markets. Its work under the partnership can include QP audit reports, QP declarations, Product Specification File creation, Investigational Medicinal Product Dossier support and batch review, batch certification, importer-of-record services, brokerage, import licensing, depot storage and distribution.
The structure creates a defined handoff between manufacturing and market entry. Material produced in the US can move through a coordinated process covering manufacturing records, quality documentation, import controls, batch certification and physical distribution before reaching clinical sites. The companies say they have already completed foundational work to establish that process.
Advanced therapy logistics carries regulatory responsibilities alongside the physical movement of the product. Manufacturing records, import permissions, quality documentation and batch certification must remain aligned with transport and storage. A shipment can therefore reach its destination but still remain unavailable for use if the documentation or release process is incomplete.
Connecting the manufacturing organisation more closely with the regional import and release partner gives each side earlier visibility into those dependencies. PQP’s contribution begins before a shipment crosses a border because the Product Specification File, dossier review and other quality work can determine whether the material is ready for certification once it arrives.
Andelyn is a US contract development and manufacturing organisation focused on cell and gene therapies, including viral-vector production. The company reports experience producing more than 500 cGMP batches and material supporting 85 global clinical trials. The partnership extends that manufacturing base into a defined UK and EU import and distribution pathway without requiring Andelyn to reproduce PQP’s regional regulatory authorisations internally.
PQP is headquartered in the UK and the Netherlands and provides quality, compliance and risk-management services to pharmaceutical, biotechnology and advanced-therapy organisations. Its regulatory licences and authorisations cover import, secondary packaging, Qualified Person release and depot and logistics services across the UK and EU.
Andelyn will remain the client-facing lead throughout project execution. That model is intended to reduce the number of separate supplier interfaces a sponsor has to coordinate, while the underlying work remains divided between the organisations according to their manufacturing, regulatory and logistics responsibilities.
The distinction matters because consolidating the commercial interface does not remove any of the regulated steps. Qualified Person certification, import licensing and batch review still have to be completed under the appropriate authorisations. The operational change is the way those activities are coordinated with manufacturing and supply planning before material begins moving.
The paperwork and physical flow are closely coupled. Product Specification Files and dossier material sit alongside batch review and certification, while importer-of-record, brokerage, storage and distribution functions determine what happens once a consignment reaches the region. A delay in either stream can stop the product progressing to the next stage.
That linkage becomes more important for time-sensitive clinical material, where long pauses between manufacturing, release and distribution can disrupt planned treatment schedules or clinical-site supply. The partnership does not guarantee shorter lead times, and neither company has published measured logistics improvements, but the operating model is designed to remove avoidable supplier handoffs around those regulated activities.
The arrangement also covers clinical and commercial pathways. Product volumes and destination networks can change substantially as a therapy progresses through development, but the requirements around import, certification and controlled distribution remain. Establishing those relationships during clinical supply can give sponsors a route that continues as programmes advance towards commercial readiness.
Andelyn and PQP are presenting the partnership during the Meeting on the Mesa conference in October. The more durable development is the creation of a standard process linking US manufacturing with authorised import and Qualified Person release in two tightly regulated markets.
Performance will depend on how well manufacturing records, quality review, border processes and physical distribution remain synchronised once live consignments move through the model. The partnership provides the operating framework; individual programmes will still carry their own product, regulatory and distribution requirements.
