Strengthening ATMP Development in Europe: How BioServices Centers in France Enable Efficiency and Scalability
As Advanced Therapy Medicinal Product (ATMP) developers progress from early-stage research to late-phase clinical trials and commercialization, biostorage, sample management, and regulatory-compliant logistics become increasingly complex. Efficiently managing these critical components is essential to ensure product integrity, regulatory compliance, and seamless supply chain operations.
Cryoport Systems’ BioServices Centers in Clermont-Ferrand and Pont-du-Château, France, provide an integrated biostorage, sample processing, and regulatory support platform designed to meet the specialized needs of ATMP clinical trials and commercial programs. And in late 2025, we will expand our capabilities even further with the launch of a new Global Supply Chain Center in Paris, designed to enhance the ATMP supply chain infrastructure and streamline distribution across Europe.
Managing ATMP Supply Chains Goes Beyond Logistics
ATMP developers often face significant hurdles beyond transportation and temperature-controlled shipping. These include:
- Biostorage Limitations: Many ATMP developers lack access to GMP-compliant, temperature-controlled biorepositories to securely store cell and gene therapy materials, research materials, and clinical samples.
- Regulatory & QP Oversight: European regulations require Qualified Person (QP) services for importation, storage, and distribution of ATMPs, adding complexity to supply chain planning.
- Sample Management & Processing: Clinical trials generate large volumes of patient samples requiring centralized processing, testing, and long-term storage to meet regulatory and study requirements.
- End-to-End Compliance: A fragmented supply chain can create gaps in chain of custody, data integrity, and regulatory documentation, leading to delays or compliance risks.
Without a fully integrated, end-to-end supply chain solution, ATMP developers risk inefficiencies that could slow down clinical progress or compromise the viability of patient-specific materials.
Integrated BioServices in France
To address these challenges, Cryoport Systems’ BioServices Centers in France provide a comprehensive suite of solutions that extend beyond logistics to support every stage of ATMP development:
GMP-Compliant Biostorage & Sample Management
- Secure, temperature-controlled storage for research, clinical and commercial materials.
- Centralized clinical sample management, including inventory tracking and real-time monitoring.
- Pre-analytical sample processing, including PBMC isolation, aliquoting, and plasma/serum extraction.
Regulatory & QP Services
- QP oversight for importation, release, and distribution of ATMP materials.
- Compliance with European Medicines Agency (EMA) regulations and GMP standards.
- End-to-end regulatory documentation and trade compliance support.
Clinical Trial Support & Custom Kitting
- Patient sample processing, testing, and centralized management to streamline clinical workflows.
- Custom kit production for sample collection, ensuring standardization and compliance.
- Packaging, labeling, and distribution for clinical and commercial ATMP shipments.
With these capabilities, Cryoport Systems ensures that ATMP developers have the infrastructure and expertise to scale operations efficiently without compromising compliance or product integrity.
A Strategic Hub for ATMP BioServices
France is a rapidly expanding hub for biopharmaceutical research, manufacturing, and clinical development. With its strong regulatory framework, skilled workforce, and growing investment in ATMPs, France provides an ideal location for centralized BioServices that support European and global clinical programs.
Cryoport Systems’ BioServices Centers in Clermont-Ferrand and Pont-du-Château serve as key infrastructure for biopharma companies, CDMOs, and clinical research organizations seeking end-to-end solutions that streamline ATMP supply chains.
Coming Soon: Paris Global Supply Chain Center
In late 2025, Cryoport Systems will expand its European infrastructure with the launch of a new Global Supply Chain Center in Paris. This facility will enhance ATMP support through integrated logistics solutions, with BioServices, biostorage, and IntegriCell™ cryopreservation services to be added in subsequent phases. As the demand for specialized ATMP supply chain services continues to grow, this facility will provide the scalability and operational efficiency needed to meet the evolving needs of the industry.
Enabling the Future of ATMPs with Integrated BioServices
A successful ATMP supply chain requires more than just logistics, it demands a fully integrated biostorage, regulatory, and sample management strategy to maintain compliance and ensure product integrity. Cryoport Systems’ BioServices Centers in France provide a seamless supply chain solution, allowing developers to focus on advancing therapies rather than managing supply chain complexities.
For ATMP sponsors, clinical teams, and CDMOs looking to scale their operations in Europe, Cryoport Systems offers the infrastructure and expertise needed to ensure certainty and compliance from clinical trials to commercialization.