PQP Group and Andelyn Biosciences Partner to Streamline EU and UK Supply Pathways for Cell and Gene Therapy Sponsors
The collaboration bridges Andelyn’s US-based cell and gene therapy manufacturing capabilities with PQP Group’s EU and UK regulatory, logistics, Manufacturing and Import Authorizations (MIAs), and Qualified Person (QP) release services to accelerate transatlantic patient access.
LONDON, UK & AMSTERDAM, Netherlands, October 6, 2026 – PQP Group, a leading European provider of quality, compliance, and regulatory release solutions for advanced therapies, today announced a strategic partnership with Andelyn Biosciences, a leading US-based, FDA-inspected cell and gene therapy Contract Development and Manufacturing Organization (CDMO).
Navigating the cross-border regulatory transition for investigational and commercial advanced therapy medicinal products (ATMPs) requires specialized compliance architectures. Operating from facilities in the UK and the Netherlands, PQP Group holds critical Manufacturing and Import Authorizations (MIAs) and delivers Qualified Person (QP) release services that enable international sponsors to import, certify, and release medicinal products into Europe and the UK in full alignment with Clinical Trial Authorizations (CTAs).
Through this partnership, PQP Group and Andelyn Biosciences establish a standardized, unified transatlantic pathway for sponsors supplying cell and gene therapy programs to clinical sites across the UK and the European Union. Both organizations have completed the operational and quality integration required to provide sponsors with a nimble, transparent, and regulatory-sound process.
The integrated service framework connects Andelyn’s development, manufacturing, and analytical operations with PQP Group’s regional release and supply chain infrastructure, including:
- Qualified Person (QP) audit reports and QP declarations
- Product Specification File (PSF) generation and maintenance
- Investigational Medicinal Product Dossier (IMPD) and batch data reviews
- EU/UK batch certification and QP release
- Importer of Record (IoR), broker, and import license management
- GMP secondary packaging, local depot storage, and clinical site distribution
This coordinated operational model allows sponsors to access European markets through Andelyn as their lead interface and single operational contact, removing the complexity of managing disparate regional vendors, customs brokers, and regulatory agents.
“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 safely and compliantly to patients.”
“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 Biosciences. “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.”
Both PQP Group and Andelyn Biosciences are attending the Meeting on the Mesa conference in Phoenix, Arizona, from October 5 – 8, 2026, to discuss transatlantic supply chain strategies with biopharma sponsors.
About PQP Group
PQP Group is a life sciences consulting and technical services 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 operational execution to support sustainable regulatory compliance and clinical advancement.
PQP Group maintains active regulatory licenses and authorizations (MIAs) for product importation, secondary packaging, Qualified Person (QP) certification/release, and depot and logistics services supporting major dosage forms and Advanced Therapy Medicinal Products (ATMPs) across the United Kingdom and the European Union.
For more information, visit pqp-group.com and follow PQP Group on LinkedIn.
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 scientific foundation has supported 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 facilities in Columbus, Ohio, Andelyn supports clients from plasmid engineering through cGMP clinical and commercial manufacturing using its configurable Curator® Cell and Gene Therapy Platforms.
For more information, visit andelynbio.com and follow Andelyn Biosciences on LinkedIn.
Media & Partnership Inquiries:
PQP Group Communications
Email: enquiries@pqpgroup.com
Website: pqp-group.com
