Immunotherapy advancements open doors for novel treatments extending patients' lives with challenging-to-treat cancers. However, the complexity and sensitivity of the processes and materials required create challenges.
Recently, a prominent biopharmaceutical company initiated research on an immunotherapy treatment for multiple myeloma - a rare cancer that affects white blood cells in bone marrow. According to the American Cancer Society, multiple myeloma has a 5-year survival rate of 58%. In this treatment, T cells, a type of immune system cell, are extracted from a patient's blood. Then, a gene for a specially designed receptor that binds to a particular protein on the patient's cancer cells, also known as a chimeric antigen receptor (CAR), is added to these T cells.
This genetic modification transforms the T cells into CAR-T cells that attack the patient's cancer cells. Large numbers of these CAR-T cells are grown in the laboratory and are given to the patient by infusion a few weeks after the process has begun.
The research project, with its delicate biological materials and high stakes, presented unique challenges that demanded precision and risk mitigation. Ensuring the integrity of these materials throughout the entire research process was crucial. To meet these demands, the research team increased their commitment to precision and risk management, focusing on cold storage. They needed storage to provide uniform cooling and stability to maintain the viability and purity of the biological material. Additionally, they required redundancy measures to prevent any system failures.
The biopharmaceutical company engaged an engineering firm to help design the research space. When it came time to consider cold storage needs, the engineering firm reached out to FARRAR® to discuss the company’s requirements and collaborate on solutions to help meet their needs. FARRAR specializes in precise temperature management for the biopharmaceutical industry and has worked on various projects with some of the largest biopharmaceutical companies. After learning about the customer's application and their critical cold storage needs, FARRAR put together a customized package that highlighted the following:
1. Precision Cooling (uniformity and stability): Temperature variations could compromise the materials; FARRAR is meticulous about maintaining consistent conditions.
2. Redundancy: FARRAR recognized the project's criticality and implemented redundancy measures. Backup systems and fail-safes help ensure uninterrupted cooling. If one system fails, another seamlessly takes over, safeguarding the materials.
3. Industry-Specific Expertise: FARRAR's experience in biopharmaceutical industry cold storage is extensive. As specialists, they understand the unique demands placed upon biological materials. They are well-versed in preserving samples, biologics, and other critical substances.
4. Integrity Protection: Ultimately, FARRAR’s primary concern is helping protect the integrity of these biological materials. Combining precision, redundancy, and specialized knowledge creates an environment where the materials remain unaltered and safe.
FARRAR® recognized the importance of this project. It was not just about storing the items but helping to advance medical research and potentially saving lives. Every decision made by FARRAR held great significance.
The customers demanded no single point of failure, which was achieved by designing two identical walk-in cold rooms. Both rooms can maintain a 4-degree temperature atmosphere, with a single-stage refrigeration system having redundant mechanics and controls. Each system has multiple alarm points that monitor the equipment's function and temperature. The walls featured an anti-microbial multicoated resilient panel finish and ceilings to complement the efforts to help reduce the risk of contamination.
The biopharmaceutical company’s research project was poised to be a game-changer in immunotherapy, paving the way for groundbreaking research and advancements. Understanding the importance of this work, FARRAR is committed to providing unwavering support to meet the evolving needs of researchers to ensure continued growth and progress toward improving treatments and patient outcomes.
As the research progresses, cold storage requirements may grow. Thanks to FARRAR's commitment to flexibility, the company can adjust to those changes. FARRAR uses decoupled zones with flexible machine sections that can adapt to any cold application. The zones are flexible and can be used for cold or ambient operation. This allows the customer to use the cold space for different applications as needs change. The system maintains temperature while automatically defrosting evaporators. More traditional technologies lack the flexibility in zoning that FARRAR can achieve and often experience the frosting of evaporators and other operational challenges. FARRAR achieves overall performance and cost-effective operation by aligning cold needs with zoning strategy. This is a customized approach that only a cold storage expert can offer.