Cell and gene therapies (CGTs) offer tremendous potential for treating various diseases. However, their temperature-controlled requirements present unique logistical challenges. To ensure the safe storage and transportation of CGTs, specialized solutions are essential. This article explores the evolving temperature-managed needs of CGTs and how biobanks, logistics service providers, and Clitec ultrafreezers are addressing these challenges.

The growing importance of CGTs

The CGT industry is experiencing rapid growth and is expected to increase by 30 % between 2019 and 2025. Pharmaceutical companies are investing heavily in CGTs because they have the potential to revolutionize healthcare. With the transition from clinical trials to commercial production, temperature-controlled logistics are becoming increasingly important.

Challenges of temperature-controlled storage

Unlike conventional therapies, CGTs require extremely cold temperatures ranging from -4 °C to -150 °C or even lower. Maintaining the integrity and efficacy of these therapies throughout the supply chain presents significant challenges. Additionally, the personalized nature of CGTs and limited industrial capacity complicate logistical requirements.

The role of biobanks

Biobanks play a critical role in the CGT supply chain. They serve not only as warehouses, but also as information management systems that work closely with manufacturers, vendors and distributors. Biobanks ensure that therapies are delivered to the right patients while maintaining the chain of identity. Compliance with privacy regulations such as HIPAA and GDPR is important to protect patient data.

The importance of Clitec Ultra Low Temperature Cooler

Clitec ultra-low temperature chillers are critical to meeting the temperature-controlled requirements of CGTs. These chambers provide precise temperature control and monitoring to ensure the integrity of therapies during storage and transport. Clitec ultra-low temperature chillers provide reliable solutions to ensure the required extreme cold temperatures to ensure the effectiveness and safety of CGTs.

Multiple storage locations

The COVID-19 pandemic has underscored the need for decentralized supply chains, which brings with it the requirement for multiple storage locations. Biobanks, logistics service providers and Clitec ultra-low temperature coolers are working together to establish a network of storage facilities that takes into account remote locations and developing countries. This decentralized approach allows for convenient collection and storage of CGTs.

Temperature sensitive packaging

To protect CGTs during storage and transportation, temperature-sensitive packaging is of utmost importance. This packaging must withstand extreme temperature fluctuations and ensure the stability of the therapies. Advanced monitoring systems and telemetry help reduce the risk of temperature deviations and ensure that therapies remain viable and effective.

Removal from temperature controlled storage

Given the complexity of temperature-controlled logistics, pharmaceutical companies are increasingly outsourcing these requirements to specialized providers. By leveraging the expertise of logistics partners and using Clitec ultra-low temperature coolers, companies can focus on research and development while ensuring efficient and cost-effective storage and transportation of CGTs.

Conclusion

Successful market entry and widespread use of cell and gene therapies depend on robust temperature-controlled logistics solutions. Biobanks, logistics providers and Clitec ultra-low temperature coolers play a critical role in meeting the unique requirements of CGTs. By outsourcing temperature-controlled storage to experts and using advanced technologies such as Clitec ultra-low temperature coolers, pharmaceutical companies can overcome the challenges associated with CGTs and accelerate the delivery of these breakthrough therapies to patients worldwide.

Quote

Leandro Moreira, Y. (2021) Cell and gene therapies’ evolving temperature-controlled requirements call for Specialized Logistics Solutions, BioPharma Dive. Available at: https://www.biopharmadive.com/spons/cell-and-gene-therapies-evolving-temperature-controlled-requirements-call/605732/ (Accessed: 04 July 2023).