Cryogenic logistics: Meeting the demands of advanced therapies

• Specialized storage: Utilization of cryogenic storage tanks, freezers, and dewars engineered to uphold ultra-low temperatures with minimal temperature fluctuations.
• Temperature monitoring and control systems: Implementation of sophisticated systems that continuously monitor and log temperature data, promptly detecting any deviations for immediate corrective actions.
• Ultra-low temperature packaging and transportation: Deployment of validated packaging solutions and transportation procedures to shield therapies during transit and prevent temperature variations. This includes utilizing packaging that incorporates technologies for tracking logistical data specific to the product, such as the duration the product remains in each entity's possession, the product's temperature history, any instances of packaging tampering, and other relevant information essential for maintaining product quality and security throughout the supply chain.
• Trained personnel: Skilled personnel who are adept in the secure handling and management of cryogenic materials are essential to guarantee the safety and integrity of therapies during storage and transportation. ICS: A trusted partner for end-to-end CGT solutions 

Acknowledging the increasing demand for specialized services in the CGT sector, we have made substantial investments in infrastructure, technology, and personnel to cater to the distinctive requirements of CGT developers. These investments enable us to offer comprehensive end-to-end solutions, spanning from clinical trials to commercialization. By prioritizing these advancements, we are committed to supporting the growth and success of our clients in the rapidly evolving CGT field.

Key capabilities of ICS

State-of-the-art cryogenic storage facilities

We operate a network of cutting-edge cryogenic storage facilities that are equipped with both manual and automated tanks, offering versatility to accommodate a wide range of ‘safe-haven’ storage requirements. The roles and responsibilities of each facility include the receipt, handling, storage, dispensing and/or disposal of a CGT product to maintain the chain of identity, chain of custody, and chain of condition. These facilities boast the following features:

• Strategic global network of depots: We have access to a network of good manufacturing practice (GMP)-compliant depots strategically positioned in crucial global locations, offering over 1.2 million square feet of space. These depots serve as hubs for LN₂/cryogenic storage, distribution, and value-added services, effectively mitigating the risk of temperature fluctuations by minimizing transport time to the final destination. Key facilities include:
  
  — Louisville, KY: Houses a 273,000 square foot CGT Center of Excellence (COE), ensuring efficient distribution operations. Our demonstrated expertise in developing tailor-made solutions for specialty products with intricate ordering requirements and stringent controls sets us apart from competitors. At this COE, we strike a balance between technical proficiency at the site of care and operational excellence in product management, giving our partners a competitive edge in the market.
  
  — EU CryoHUB (Viladecans, Barcelona, Spain): A dedicated cryogenic storage facility spanning approximately 43,056 square feet, offering access to the European market with flexible next-day air shipment options. The site operates within specific control limits for temperature, humidity, and gases such as oxygen and CO2, which support clinical handling. 
  
  — National distribution reach: Leveraging just-in-time (JIT) dropship capabilities in synergy with our distribution network, our CGT team is dedicated to understanding and addressing the specific needs of our partners. We are unwavering in our commitment to providing tailored solutions that support our partners' success and ultimately lead to improved outcomes for patients.
  
  
• Custom storage solutions: Tailored storage and cyrogenic equipment solutions designed to meet the specific requirements of each therapy, supported by robust policies, procedures, and validation protocols. With extensive experience in managing various CGT programs, we prioritize optimal redundancy and continuity measures.
  
  — Variety of manual and automated tanks: We offer a diverse range of storage options that can be customized to suit specific needs, resulting in reduced retrieval time and sample warming rates, thereby enhancing efficiency and maintaining sample integrity. Our storage facilities have alarms and conform to industry standards for immediate action, investigation, and appropriate corrective action in case of temperature deviations.
  
  — Secondary packaging room: Our secondary packaging room allows for the execution of highly intricate packaging tasks in a dedicated area of excellence, free from distractions. This setup includes client-focused workstations that are designed to enhance efficiency and precision in the packaging process.

End-to-end cryo logistics solutions

In addition to storage services, our capabilities extend to the safe and reliable delivery of temperature-sensitive biologics, ensuring the secure transportation of critical therapies to healthcare providers and patients. This comprehensive offering includes:

• Global reach with local expertise: Leveraging our global network alongside local knowledge enables us to assist clients with international distribution requirements. Our collaboration with World Courier, a prominent global logistics provider and a fellow Cencora company, enhances our ability to navigate the complexities of cross-border transportation. Dedicated customer support teams in each region further ensure seamless communication and effective issue resolution.
• GMP relabeling: Provision of on-site kitting and labeling services within an FDA-approved isolated packaging room, guaranteeing compliance with GMP standards. With over a decade of proven experience in this field, we ensure the highest standards of quality and regulatory compliance.
• Order-to-cash support: Comprehensive services in order processing, cash management, and collection services, facilitate streamlined financial management for clients. This scalable solution, coupled with the specialized distribution capabilities of ICS and Cencora, enables swift scalability across all stakeholders, enhancing operational efficiency and financial processes.
• High-touch freezer-pro applications: Our quality system, supported by a specialist risk and integration team, is overseen by a designated individual responsible for reporting on new program quality system initiatives to executive management. This structured approach ensures continuous improvement, adherence to standards, and proactive risk management within the organization's operations.
• Temporary or hybrid title model services: ICS maintains licensures for all applicable CGT product activities from the relevant authorities. We have CGT standards that go beyond requirements for the receipt, handling, storage, dispensation, and/or discard of approved (e.g., FDA, competent authority, local, federal and regulatory body) cell and gene therapy products to maintain the product quality and safety while in possession of our 3PL.
• Highly trained personnel: We recognize the critical role of our personnel in maintaining the integrity of CGT products throughout the supply chain. Our operations have implemented a new standard that prioritizes focused training and establishes a clear framework for ongoing job training aligned with these standards.

Focus on patient services 

We recognize that the success of CGTs depends on not just efficient logistics, but the delivery of comprehensive support to patients as well. Our patient services capabilities ensure that patients receive the necessary guidance and assistance throughout their treatment journey. This includes:

• Patient access programs: Support for patient access programs to ensure patients can access the therapies they need.
• Personalized support: Tailored support services to address the unique needs of each patient, including education, counseling, and financial assistance.

This collaboration highlights our proficiency in cryogenic logistics, while the commercialization of the first HLA matching cell therapy in the US market is a testament to the power of effective partnerships in the pharma industry. This allogeneic T-cell therapy targets the life-threatening EBV post-transplant lymphoproliferative disease (PTLD). We played a crucial role by offering third-party logistics storage, logistics, and patient services, significantly contributing to the successful launch of this pioneering therapy in the U.S. market.

Our comprehensive approach ensured the safe and efficient delivery of this allogenic therapy to patients, showcasing our dedication to excellence in managing complex therapies. The partnership resulted in an estimated revenue of $16.35 million over a three-year period, emphasizing our ability to deliver tailored and effective solutions for intricate therapeutic products.

ICS: Advancing cryogenic logistics for the CGT therapy revolution

Cryogenic logistics plays a pivotal role in the success of CGTs. With our comprehensive capabilities and dedication to innovation, ICS is strongly positioned to support the biopharmaceutical industry in addressing the rising demand for these specialized services. Our expertise in managing temperature-sensitive biologics, coupled with our global presence and patient-focused approach, positions us as a reliable partner for companies striving to bring life-saving therapies to patients globally.

As the CGT sector progresses, the necessity for cryogenic logistics will only grow. We are steadfast in our commitment to enhancing our capabilities, expanding our network, and adapting to the evolving requirements of the biopharmaceutical industry. By doing so, we aim to play a significant role in facilitating the delivery of life-saving treatments to patients worldwide.