FARRAR Package CASE STUDY CHALLENGE A large health system with a pharmacy focused on managing and dispensing investigational drugs for research participants and clinical teams was expanding. They needed additional cold storage space to accommodate the new APIs required for critical research that would be ongoing for an undefined amount of time. The pharmacy is a core facility that provides services to investigators throughout the health and attached educational system. They offer a wide range of investigative products, natural products, biologics, and medical devices. With this expansion, additional cold storage was needed to accommodate growth demands. The client used fifteen reach-in refrigeration systems, each requiring its own validation process. The refrigeration system required a standard 4°C temperature, but with the ever-changing demands of the health system flexibility and efficiency were critical. Frequent access made maintaining exact temperature control challenging and put the quality and viability of the biologics stored at risk. Page 01-03 / FARRAR ES Health System Case Study SOLUTION Helmer® Scientific, a business of Trane Technologies Life Science Solutions, had a long-term relationship with the client. Helmer is considered an expert at providing innovative technology and a high level of service within the large health system as a supplier of various cold storage solutions. The compounding pharmacy contacted Helmer to discuss their current situation and growing needs. The Helmer representative conducted a site visit and discovered that the client had specific needs. The visit and needs assessment led the Helmer representative to conclude that a walk-in cold room was the ideal solution for the client. They took a consultative approach and partnered with FARRAR®, a sister business within Trane Technologies, to devise this cold storage space. FARRAR's Engineered Solutions team specializes in proven, engineered, integrated, controlled-environment walk-in and drive-in cold storage including bulk storage, blast-freeze, and production freezers. RESULTS Helmers's strong relationship with the client enabled the trust needed to transition from a reach-in environment to a walk-in cold storage solution. The FARRAR ES team consulted with the client to engineer a solution that addressed the immediate need for cold storage and provided efficiencies that reduced validation demands and created redundancies as well as energy savings. The shift from validating fifteen reach-in refrigeration units to one walk-in room was a tremendous process time saver. Each unit would have required individual temperature mapping, maintenance, and regulatory compliance checks, making the process more demanding and labor-intensive. Evaluating energy efficiency and maintaining and managing regulatory compliance for one room versus multiple units also became more streamlined. The 4°C walk-in cold room was designed for easy access to its stored contents. The 14'w x 10'd x 8.5'h chamber contained a custom-tracked 11' racking system that allowed the customer to get in and out of the chamber quickly. It reduced the number of door openings needed, saving them money and energy consumption while supporting the need for precise temperature control. The client was delighted with its new centralized cold storage solution, eliminating 15 reach-in units and creating extra floor space for other purposes. Redundant units are no longer necessary in the event of equipment failure. They were designed with fully redundant condensing units, evaporators, and electronic expansion valves to help safeguard critical materials. Ultimately, implementing a walk-in solution negated the need for multiple reach-ins. Page 02-03 / FARRAR ES Health System Case Study INSTALLATION AND QUALIFICATION FARRAR® offers installation and qualification services for temperature-controlled systems. Their process includes project management, turnkey installation, start-up, commissioning, and IQ/OQ/ PQ/quality assurance programs. With FARRAR's validation offerings, customers can have peace of mind knowing that their systems are installed and operating in accordance with the manufacturer's specifications and global regulations. In addition to the IQ/OQ/PQ services, FARRAR provides a temperature validation package to certify a unit's temperature performance. This package comes with a documented program that ensures a high degree of assurance that the equipment will provide temperature uniformity throughout the unit and meet predetermined acceptance criteria. LEARN MOREabout FARRAR's capabilities and services for temperature-controlledsystems. 800-B Beaty Street Davidson, NC 28036 T: +1 (740) 374-8300 | (800) 242-7197 lssinfo@tranetechnologies.comwww.farrarscientific.com All trademarks referenced are the trademarks of their respective owners. © 2024 Trane. All Rights Reserved. LSFL-SLX002-EN 8-15-24 CASE STUDY CHALLENGE 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. Page 01 / FARRAR ES Immunotherapy Case Study 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. SOLUTION 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. Page 02 / FARRAR ES Immunotherapy Case Study 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 impor- tance 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. RESULTS 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. Page 03 / FARRAR ES Immunotherapy Case Study INSTALLATION AND QUALIFICATION FARRAR® offers installation and qualification services for temperature-controlled systems. The process includes project management, turnkey installation, start-up, commissioning, and IQ/OQ/PQ/quality assurance programs. With FARRAR's validation offerings, customers can have peace of mind knowing that their systems are installed and operating in accordance with the manufacturer's specifications and global regulations. In addition to the IQ/OQ/PQ services, FARRAR provides a temperature validation package to certify a unit's temperature performance. This package comes with a documented program that ensures a high degree of assurance that the equipment will provide temperature uniformity throughout the unit and meet predetermined acceptance criteria. LEARN MORE about FARRAR's capabilities and services for temperature-controlled systems. 800-B Beaty Street Davidson, NC 28036 T: +1 (740) 374-8300 | (800) 242-7197 lssinfo@tranetechnologies.comwww.farrarscientific.com © 2024 Trane Technologies Life Sciences LLC. All rights reserved. All trademarks referenced are the trademarks of their respective owners. LSFU-SLX004-EN 4-29-24 CASE STUDY SITUATION When a major pharmaceutical manufacturer encountered technical issues on their built-in ultra-low temperature storage freezers, engineers at FARRAR™, powered by Trane Technologies, were able to go in and fix the problem - even though they weren't the original freezer equipment manufacturers. Resolving the issue was critical given the $1 billion value of the new drugs being stored. In just 72 hours, the immediate problem was solved giving facility operators a sense of temporary relief. It was clear, however, that further challenges still existed. Worse, there was no system in place to better predict those system challenges so they could be resolved before they became big issues and potentially impacted the quality of the drugs. Page 01 / FARRAR's Predictive Analytics Help Eliminate $300 Million in Annual Drug Loss SOLUTION The newly commercialized drug product, a major development for the drug manufacturer, required consistent storage at -40°C. After thoroughly evaluating the current cold storage system, FARRAR engineers made some recommendations. This included adding analytic instrumenta- tion of the existing system to help manage pressure, amperage, cycle time, defrost time, superheat, oil pressure and other critical parameters. They also recommended a key monitoring-strategy shift. The engineers proposed that the drug manufacturer implement a process to continually evaluate freezer performance. Historically, drug companies have focused on meeting requirements as determined by the FDA which requires only that the drug product, not the storage conditions, meet specific criteria. Manufacturers typically determine whether drugs are properly stored by evaluating the quality of the drug product rather than freezer performance. If the final drug doesn't meet quality specifications, it needs to be disposed of. FARRAR proposed adding its proprietary Predictive Analytics to the freezers, an approach which would allow the drug manufacturer to monitor freezer performance. These predictive analytics function much like those used in automobiles today. In vehicles, similar systems indicate when fluids are low, or the vehicle's engine needs to be checked. This Predictive Analytics system programmed specifically for freezers would check in multiple times a minute to assess key parameters and alert if anything needs attention. The drug manufacturer agreed that the recommended monitoring solution added value and helped to provide an additional layer of drug quality protection. FARRAR engineers installed Predictive Analytics, providing the customer with ongoing monitoring and regular reports regarding storage performance. The Predictive Analytics system regularly monitors temperature, oil pressure, (air) pressure and air flow, uploading the data to the cloud 24/7 for review by FARRAR engineers. "We're actually measuring the operation of the equipment itself," said Scott Farrar, Chief Technology Officer. The data is reviewed daily by FARRAR engineers, who alert the customer if it is not trending properly. This process helps the customer plan for drug product relocation if necessary to mitigate loss. Page 02/ FARRAR's Predictive Analytics Help Eliminate $300 Million in Annual Drug Loss RESULTS After installing FARRAR's Predictive Analytics, the customer gained 24/7 direct feedback to help ensure consistent cold storage and better protection of its valuable drug investment. The monitoring system shifted the checkpoint from the final drug product to the storage system - giving the manufacturer the opportunity to resolve potential issues before they impact final drug quality. In this case, thanks to the ability to resolve issues before they impact drug quality, the manufacturer prevented an estimated potential drug loss of $300 million, while also gaining priceless peace of mind. LEARN MORE about FARRAR's Predictive Analytics and other Conditional Preventive Maintenance components and offerings. 800 Beaty Street Davidson NC 28036 T: +1 (740) 374-8300 (800) 242-7197 www.farrarscientific.com ©Trane Technologies Life Sciences LLC All trademarks of their respective owners LSFU-SLX002-EN 11-18-2022
