Andelyn Biosciences and PQP Group Partner to Streamline EU and UK Supply Pathways for Cell and Gene Therapy Sponsors
COLUMBUS, Ohio, October 6, 2026 — Andelyn Biosciences (“Andelyn”), a leading US-based patient-focused cell and gene therapy Contract Development and Manufacturing Organization (“CDMO”), and PQP Group today 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.
Both companies will attend the Meeting on the Mesa conference October 5-8, 2026.
About Andelyn Biosciences
Andelyn Biosciences is a full-service FDA-inspected cell and gene therapy commercial CDMO focused on developing, characterizing, and producing viral vectors for gene therapy. With more than 20 years of experience, Andelyn’s deep scientific expertise has resulted in the production of clinical and commercial material for more than 500 cGMP batches and 85 global clinical trials, including an FDA-approved gene therapy. Operating out of its development and manufacturing facilities in Columbus, Ohio, Andelyn supports its clients in developing cell and gene therapies from concept through plasmid engineering and manufacturing, process and analytical development, and cGMP clinical and commercial manufacturing. Andelyn can accelerate programs and deliver high-quality products by developing and manufacturing processes on its configurable, data-driven Curator® Cell and Gene Therapy Platforms, or by tech transfer within an established client program. Capabilities include cGMP manufacturing for suspension and adherent processes. A rigorous, commercial-grade quality system, phase-appropriate manufacturing, and supply chain vertical integration further help clients bring critical therapies to market.
For more information, please visit andelynbio.com and follow Andelyn Biosciences on LinkedIn.
About PQP Group
PQP Group is a consulting firm providing specialized quality, compliance, and risk-management solutions tailored for pharmaceutical, biotech, and cell and gene therapy organizations. The firm delivers quality leadership and execution support to life sciences organizations, helping clients achieve sustainable compliance and operational excellence.
PQP Group has established regulatory licenses and authorizations for import, secondary packaging, QP release, and general depot and logistics services supporting major dosage forms and advanced therapy products within the UK and EU.
Follow PQP on LinkedIn.