Optimizing ATMP Cryopreservation: How IntegriCell™ Services in Belgium Ensure Cell Viability and Supply Chain Integrity 

Cryopreservation is quickly becoming a critical yet often underestimated component of the Advanced Therapy Medicinal Product (ATMP) supply chain. The success of cell-based therapies depends on maintaining cell viability, stability, and consistency, yet variability in cryopreservation methods has compromised therapeutic outcomes. 

Many ATMP developers have struggled with inconsistent freezing protocols, logistical bottlenecks, and regulatory hurdles, all of which can impact product quality. To address these challenges, Cryoport Systems launched the IntegriCell™ Cryopreservation Center in Villers-le-Bouillet, Belgium, in 2024. This facility, along with the IntegriCell™ cryopreservation services offered at our Global Supply Chain Center in Houston, TX, provides standardized, validated cryopreservation solutions to deliver consistent, compliant, high-quality leukapheresis starting material essential for cell-based therapies. Our services ensure that every batch meets the stringent standards required for successful therapeutic outcomes, significantly reducing variability and enhancing reliability. Our standardized protocols address product stability issues associated with fresh donor-derived cellular material for an optimized approach that enhances manufacturing efficiency and streamlines operations. 

 

Cryopreservation as a Supply Chain Risk 

Cryopreservation is more than just freezing cells, it is a complex, highly controlled process that determines the viability and functionality of ATMPs throughout the supply chain. Key challenges have included: 

  • Process variability across collection and manufacturing sites, leading to inconsistent product quality. 
  • Viability loss due to suboptimal freezing, storage, or transport conditions, which can reduce therapeutic efficacy. 
  • Complex logistics requiring specialized cold chain management, near real-time monitoring, and stringent temperature control to prevent fluctuations. 
  • Regulatory requirements for validated, standardized cryopreservation protocols to ensure quality and reproducibility across clinical and commercial programs. 

Without rigorous cryopreservation standardization and an integrated supply chain strategy, developers risk losing valuable therapeutic material, delaying trials, and facing regulatory setbacks. 

 

IntegriCell™ Cryopreservation in Belgium 

Cryoport Systems’ IntegriCell™ Cryopreservation Center was purpose-built to address these challenges, offering ATMP developers access to: 

  • Standardized, validated cryopreservation processes that reduce variability and improve product consistency. 
  • Controlled freezing and storage conditions that maintain cell viability and therapeutic efficacy. 
  • Integrated logistics and cold chain solutions to ensure seamless transport between collection, manufacturing, and clinical sites. 
  • Compliance with European and global regulatory requirements, providing the necessary documentation and quality assurance for clinical and commercial programs. 

By enhancing the safety, quality, and viability of manufacture-ready cryopreserved leukopaks for cell-based therapies, the Belgium facility supports ATMP developers in optimizing the transition from research to commercial-scale production. 

 

Strengthening ATMP Supply Chains with Cryopreservation Excellence 

As cell and gene therapies continue to advance, the ability to maintain high-quality, viable therapeutic materials throughout the supply chain has become a decisive factor in clinical and commercial success. The IntegriCell™ Cryopreservation Center in Belgium provides developers with a proven, standardized approach to cryopreservation, reducing risks and ensuring that each therapy reaches patients in its most effective state. 

For ATMP developers, contract manufacturers, and clinical teams looking to optimize their cryopreservation and supply chain strategy, Cryoport Systems offers the infrastructure and expertise needed to protect the integrity of life-saving therapies at every stage.