The Andelyn PQP partnership is aimed at one of the less glamorous but more stubborn problems in gene therapy: getting a product made in the United States legally and reliably to patients in Europe and the UK. Andelyn Biosciences, a US cell and gene therapy contract manufacturer based in Columbus, Ohio, and PQP Group, a UK and Netherlands quality and compliance consultancy, announced on 6 October 2026 that they will coordinate the clinical supply of cell and gene therapy products from the US into the EU and UK.
Under the arrangement, Andelyn handles development, manufacturing, quality and supply chain, while PQP supplies the European and UK regulatory, import and distribution pieces. The release says it covers both clinical and commercial material. This article walks through how the supply route works, what each side brings and what the announcement leaves out.
Andelyn PQP partnership at a glance
- Announced: 6 October 2026.
- Purpose: a coordinated supply pathway for US-made cell and gene therapy products going to the EU and UK.
- Scope: clinical and commercial material, supporting clinical trial authorisations.
- Model: Andelyn is the sponsor’s single point of contact; PQP works behind it.
- Not disclosed: financial terms, duration, exclusivity, named sponsors or products.
The problem: two regulatory regimes between a US plant and a European patient
A gene therapy made in Ohio cannot simply be shipped to a hospital in Amsterdam or Manchester. In the EU and the UK, each batch of a medicine generally has to be certified by a Qualified Person (QP) before release, the product must be brought in by a licensed importer, and the paperwork must match what regulators approved in the clinical trial authorisation or marketing authorisation. The EU and the UK now run separate systems, so a sponsor supplying both has two sets of requirements to meet. For small and mid-sized biotechs, which often rely on a contract manufacturer for everything, building that capability from scratch is slow and expensive.
Why gene therapy makes supply harder
Advanced therapies are less forgiving than tablets. Viral vector products are typically produced in small batches, are valuable per vial, and are often stored frozen and shipped under strict temperature control. A missing document or a delayed certification therefore costs more than it would for a conventional medicine, because a trial site may be waiting on a handful of doses. That is the gap this partnership says it will close, although the announcement gives no data on turnaround times.
How the supply route works
The release lists the services in the pathway. In sequence, they form a route from the US plant to the clinical site:
- 1. Manufacture and quality in the US: Andelyn produces the viral vector or product under cGMP conditions and manages quality and the supply chain.
- 2. QP audit and declaration: PQP provides QP audit reports and QP declarations on the manufacturing site.
- 3. Product Specification File: PQP helps create the file that describes the product for EU and UK release.
- 4. Dossier and batch review: PQP supports the Investigational Medicinal Product Dossier (IMPD) and reviews each batch record.
- 5. Batch certification: a QP certifies each batch for release into the EU or UK.
- 6. Import and shipping: PQP acts as importer of record and broker, holds the import licence and provides depot storage.
- 7. Distribution: support for delivering the product to clinical sites.
What each partner brings
Andelyn describes itself as an FDA-inspected CDMO focused on viral vectors, with more than 20 years of experience, over 500 cGMP batches, support for 85 global clinical trials and an FDA-approved gene therapy. Its Curator platforms cover plasmid, process and analytical development as well as clinical and commercial manufacturing.
PQP Group is a quality, compliance and risk-management consultancy for pharmaceutical, biotech and cell and gene therapy companies. It is headquartered in the UK and the Netherlands and holds manufacturing and import authorisations, with UK and EU licences for import, secondary packaging, QP release, and depot and logistics services. Both sets of credentials are company statements.
Why it matters for sponsors
The practical effect is that a sponsor running trials on both sides of the Atlantic would deal with one lead contact. Matt Niloff, Andelyn’s chief commercial officer, calls it an integrated approach that combines manufacturing and quality with EU and UK QP, import and distribution expertise. Stephan Croft, PQP’s co-founder and QP, describes a coordinated clinical supply offering for sponsors entering the EU and UK. If it works as described, sponsors avoid having to select, qualify and manage a separate European importer and releasing site.
For related manufacturing news, see our reports on Ofichem’s plan to acquire Kinentia Biosciences and Axplora’s European exatecan supply.
What the announcement does not say
- Any financial terms, contract structure, duration or exclusivity.
- Which sponsors or products will use the route first.
- Turnaround times, costs or capacity.
- Any performance data or completed projects.
- How the route handles products with very short shelf lives, such as some cell therapies that depend on cold-chain timing.
In our assessment
This is a services partnership, not a technology breakthrough, and its value will be judged by reliability. Supply failures in cell and gene therapy can delay a trial or leave a patient without treatment, so the test will be whether the combined offering shortens lead times and reduces regulatory surprises. A named customer, or a case study with timelines, would be the first real evidence. Until then, it is best read as a signal that US manufacturers are packaging European access as part of their offer.
What to watch next
- The first named sponsors using the route.
- Any expansion to other regions or services.
- Regulatory changes affecting EU and UK imports of advanced therapies.
Frequently asked questions
What is the Andelyn and PQP partnership?
A collaboration to coordinate the clinical and commercial supply of US-made cell and gene therapy products into the EU and UK.
What does PQP provide?
QP audits and declarations, product specification and dossier support, batch review and certification, import and shipping, depot storage and distribution support.
What does a Qualified Person do?
A QP certifies that each batch of a medicine was made and checked according to the rules before it is released for use in the EU or UK.
Who is the sponsor’s contact?
Andelyn is the lead contact and single point of contact throughout project execution.
Were financial terms disclosed?
No.
How we reported this: we relied on the company announcement of 6 October 2026. Descriptions of the regulatory background are our general explanation. Last updated: 9 October 2026. This article is news reporting and not regulatory or legal advice.
