A Biopharmaceutical Company’s Journey to Savings and Optimized Sample Management

azenta.com Sample Management and Automation A Biopharmaceutical Company’s Journey to Savings and Optimized Sample Management through Partnership with Azenta CASE STUDYSample Management and Automation | Case Study Azenta Life Sciences 2 The Challenge A top global biopharmaceutical company providing life-changing treatments in areas like oncology, immunology, and neurology needed to improve compliance, gain visibility, and enhance efficiency in the management of their clinical and research samples. Multiple factors converged that required action: • Clinical samples were being managed by a central lab partner that had supported their clinical trials. Access to these samples was limited and the cost for longterm storage was escalating. • There was a fragmented approach to management of samples across the departments with multiple inventory systems in use, limited access to tracking information, and inconsistent terminology. • The company was undergoing a transformation within its research and development (R&D) structure. As part of this restructure, scientists spread across 8 sites in one region would be moved into a single R&D hub to maximize collaboration and scientific output. Across these 8 sites there were approximately 1,400 storage units and a large portion of non-centralized inventories. While the immediate issue that needed to be addressed was consolidating the 8 R&D sites, they also had a total of 21 R&D facilities across the globe with similar challenges. The organization was charged with addressing: Catalog R&D groups across mixed samples reduction of Create a centralized inventory for cold storage units in less than a year mixed samples 14 1M+ 43% 8 sites 1375 2M+Sample Management and Automation | Case Study Azenta Life Sciences 3 The Solution To choose the right partner, the biopharmaceutical company examined the most critical attributes for success from both quantitative and qualitative perspectives. For them, it was not just important to solve their challenges, but to ensure a solution that would be scalable and ultimately improved by working with the right partner. Experience – Is there a clear understanding of project and budget requirements? Can we rely on this partner’s business development and support teams to be responsive and flexible? Planning – Are we future-proofing our strategy to meet the needs of tomorrow? Is there a master service agreement (MSA) and durable documentation in place? Capabilities – Can our partner handle all aspects of project logistics; both high volume processing and shipping of 1000 samples per day, as well as informed consent form (ICF) de-coding for clinical work? Will our partner scale with our genomics and proteomics needs from research through CAP/CLIA lab services? Reputation – Is our partner an industry leader for pharmaceutical customer site services with a positive track record of references? Leadership from the pharmaceutical company decided to reach out to the sample management community for guidance and support. The company contracted two service providers for an inventory pilot. The providers were assessed for contract and quality compliance with support through Informed Consent Form (ICF) annotation. A global pilot program was established with three primary project goals: (1) establishment of biorepository local cores at the client sites; (2) creating a unified, global inventory for samples stored in-lab, in the local core, or at Azenta; (3) executing local deployment of tactics. Stakeholders from clinical, research, procurement, quality, digital, data, and leadership teams evaluated the results of these activities and Azenta Life Sciences emerged as the partner of choice. The sample management and exploration expertise offered by Azenta provided the confidence and security to implement solutions for the following: • Rationalization of research and clinical samples to ensure only samples suitable for use were retained • Inventory of all human biological and cell line samples at a sample level to ensure compliance • Inventory of critical reagents and common use biologicals for optimization of inventory • Enabling global visibility and searchability through unified inventory data terminology • Establishing a modular approach to sample storage based on use parameters • Optimization of storage space resulting in reduced carbon footprint and operating and capital expensesSample Management and Automation | Case Study Azenta Life Sciences 4 The Details ESTABLISHING LOCAL CORES Client laboratory management established global governance and compliance for samples to ensure an efficient use of space and budget that suited the urgency of research needs. Azenta provided guidance for narrowing samples into three storage options that offered the flexibility to meet all these challenges with storage and transportation solutions in the lab, on-site at a local core, or at Azenta (Figure 1). In-lab samples were defined as those needed daily/weekly for active projects. The local core would house samples that may require same-day delivery to the lab. All other samples that were retained were to be sent to Azenta for 24–48-hour delivery to users upon request. Standard operating procedures (SOPs) were formalized to ensure users working with sample inventory could correctly route them to a final destination. CONTINUED RESEARCH DURING SAMPLE MANAGEMENT IMPROVEMENT Program activities were driven by 4 teams comprised of members from both Azenta and the pharmaceutical company; Biorepository, Digital, Compliance, and New Sample Acquisition. These 4 teams worked together to ensure the overall mission of the program was met. The initial activities of the Biorepository team focused on change management. Scientists were used to keeping their materials (samples, critical reagents, and equipment) in the lab, which had accumulated over the years. With turnover in staff and limited inventory management, there was some material in the units that had little to no information associated with them. Decision trees for which materials to retain versus which to discard were established, along with guidance for how and where to store these materials in the future and the benefits this would bring to the researchers. With less than 50% of materials cataloged, the Digital team’s solution consisted of integrating and replacing the multiple existing inventory systems with a single system as well as digitizing non-inventoried samples. Azenta assisted the digital team by verifying information for samples already cataloged against the physical sample, ensuring that any required information available on the material or material storage container was captured using consistent nomenclature, and recording the exact location of each material. Any materials that were not in an inventory system USE DAILY/WEEKLY In the Lab OPTION A SAME DAY DELIVERY At the Local Core OPTION B 24-48 HR. DELIVERY At Azenta OPTION C Ambient, +4°C, -20°C, -70°C, -80°C & LN2 Figure 1. Example of Azenta guidance for sample culling and storageSample Management and Automation | Case Study Azenta Life Sciences 5 were fully cataloged by Azenta and then linked to critical metadata. This digital process allows client scientists to access any sample from anywhere in the world. The Compliance team was a critical partner for ensuring that the materials retained, and data captured against them, were in line with the human subject regulations and licensing requirements. The New Sample Acquisition team focused on commercially-acquired sample compliance and efficiency. These teams worked concurrently to begin the execution of this program in three phases. PHASE Q3-Q4 2021 150K samples 30 users 01 PHASE Q1-Q2 2022 1.5M samples; 50K cell lines 530 users 02 PHASE Q3-Q4 2022 2.2M samples; 300K cell lines 2500+ users 03 LOCAL CORE SET-UP • Global governance and compliance (establish SOPs, culling samples) • Pilot core set-up (2 sites) DIGITAL PLATFORM • Database set-up for core • Integration of exisitng inventories LOCAL DEPLOYMENT • Freezer cleaning and inventory (2 sites) LOCAL CORE SET-UP • Local governance and compliance • Continued core set-up DIGITAL PLATFORM • Continued database set-up for core and integration of existing inventories LOCAL DEPLOYMENT • Completed deployment at one site • Freezer cleaning and inventory expansion to remaining 6 sites • Sample movement to Azenta biorepositories LOCAL CORE SET-UP • Complete local governance and compliance • Running activities for cores DIGITAL PLATFORM • Advanced search and analytics implementation • Continued integration of existing inventories • Replacement of legacy solutions LOCAL DEPLOYMENT • Complete freezer cleaning and inventory • Final sample movement to Azenta biorepositoriesSample Management and Automation | Case Study Azenta Life Sciences 6 LOCAL DEPLOYMENT To initiate the proposed execution, Azenta equipment and technical teams visited client sites to establish an on-site presence and enable a close partnership throughout the process. These teams guided users in considerations for sample culling and storage assignment while also providing automated liquid nitrogen (LN2) freezers for local core storage. This process of culling, storage prioritization, and laboratory optimization resulted in a 47% reduction of cold storage units (CSUs) at the customer’s site while still maintaining back-up units and space for surge activity (Figure 2). Inventory of materials was performed both at the client and Azenta sites depending upon whether scientist support was needed to help identify the material. Regardless of storage location, all inventory activities were performed under Azenta SOPs with population of client-required fields. Data wrangling services were also utilized to standardize variable nomenclature and organize data for loading into the digital solution. Innovative technologies were implemented in conjunction with the inventory to facilitate the reduction in CSUs. For example, materials from 51 manual LN2 tanks were consolidated into 13 automated LN2 units provided by Azenta. With the library control feature on the automated freezers restricting access to individual boxes to only the sample owners and trained biobank personnel, the scientists gained confidence in the use of shared storage environments for their most precious biological samples. New tools were also put into place to allow for more efficient sample management at the bench. Pre-barcoded tubes and barcode readers were made available to scientists to aid in sample tracking activities and reduce transcription errors that can be found with manual labeling practices. These tubes were also automation friendly to allow for efficient downstream uses. At the time of publishing this study, the 8 original US facilities had successfully relocated to the new building. Material deliveries from the local core and Azenta long-term storage facility are occurring on a regular basis. In addition, inventory efforts have begun at two of the client’s facilities in Europe using the same proven methods applied in the US. In total, Azenta will provide inventory services at 21 locations for the customer in support of this project. 1 Asset inventory to conrm number of CSUs 2 Inventory planning and prioritization 3 Box-level inventory and racking assessment 4 Assessment facilitation 5 Sorting, labeling, and transporting for discard, short-term storage, or long-term storage Figure 2. Process Overview for Reduction of 1400 Cold Storage Units to 740Sample Management and Automation | Case Study Azenta Life Sciences 7 The Results Azenta partnered with this multinational biopharmaceutical client to provide a better storage management solution. Through the rationalization and inventory of the samples using standardized methods and terminology, the client has full visibility to their biological samples and other materials. This enables sharing of the samples and adheres to compliance requirements associated with human biological samples and licensed materials. New tools and processes were put into place to enable ongoing sample management in an efficient manner, reducing the overall cost of operations and significantly decreasing the carbon footprint associated with cold storage. The long-term storage materials at Azenta are easily accessible to the scientists. CAP-accredited sample processing options, such as nucleic acid extraction and automated aliquoting, allow the client to obtain their samples in testready format. Azenta also offers genomic, transcriptomic, and proteomic analysis, maintaining visibility and chain of custody of the samples. ANNUAL METRIC TON REDUCTION IN CO2 EMISSIONS WITH REDUCTION IN STORAGE FLEET AND ADDED TRANSPORT REQUIREMENTS The transformative impact of this program was recognized internally by the client as their project team leading the efforts received the company’s 2022 Global R&D Award. CONSOLIDATED SITES AND CREATED CENTRAL INVENTORY 418 HOMES’ ELECTRICITY USE FOR 1 YEAR 4.979 BARRELS OF OIL CONSUMED 2,379,394 POUNDS OF COAL BURNED 241,989 GALLONS OF GASOLINE CONSUMED 5,338,120 MILES DRIVEN BY AN AVERAGE GASOLINEPOWERED PASSENGER VEHICLE EQUIVALENT CO2 EMISSION SAVINGS REDUCED PROCUREMENT EFFORTS CUSTOMER SITE COST OF OPERATIONS REDUCTION THROUGH OPERATING EXPENSE, CAPITAL, AND SPACE SAVINGS MOVED TO AZENTA FOR LONG TERM STORAGE WITH PLANNED 2-YEAR EVALUATION CYCLE IMPROVED LEGAL AND COMPLIANCE PROCESSES WITH INFORMED USAGE AND TRACEABILITY REDUCTION IN COLD STORAGE UNITS AT CLIENT’S FACILITY FOR SHORT AND MEDIUM STORAGE REQUIREMENTS Source for CO2e Saving Equivalents: Greenhouse Gas Equivalencies Calculator | US EPASample Management and Automation | Case Study azenta.com © 2023 Azenta US, Inc. All rights reserved. All trademarks are property of Azenta US, Inc. unless otherwise specified. 77004-CS 0423 EXPLORE BETTER MANAGEMENT STORAGE SOLUTIONS → Conclusion Streamlining material storage and management poses many unique challenges. Azenta answered these client challenges with decades of experience, meticulous and thoughtful planning, expansive capabilities, and a respected reputation. By integrating industry-leading sample capabilities and enterprise-wide sample exploration and management solutions, Azenta Life Sciences partnered with this client to improve operations and accelerate therapeutic discovery, development, and delivery. These leading solutions across inventory services, multiomics, cryogenic storage, automation, and informatics are dedicated to accessing new frontiers in sample exploration and management to partner with clients bringing impactful breakthroughs and therapies to market with greater speed and reliability. Find out how you can minimize risk, improve sample quality, and enhance access for your own valuable samples, materials, and drug products with a complete better storage management solution for pharmaceutical research from Azenta Life Sciences. “AZENTA HAS BEEN AN OUTSTANDING PARTNER IN OUR TRANSFORMATION JOURNEY. AIMING TO BUILD A HOLISTIC R&DWIDE FRAMEWORK TO MANAGE THE ENTIRE LIFECYCLE OF OUR BIOLOGICAL SAMPLE COLLECTION IN AN EFFICIENT AND COMPLIANT MANNER, AZENTA ACCOMPANIES EVERY STEP OF OUR TRANSFORMATION THROUGH A STRONG AND DIVERSIFIED SET OF SERVICES, THROUGH THEIR EXPERT KNOWLEDGE AND STATE-OFTHE-ART CAPABILITIES, AND THROUGH THEIR COMMITMENT TO ADAPT CONSTANTLY TO MEET OUR SPECIFIC REQUIREMENTS AND DIFFERENT LOCAL NEEDS, ALL IN A TRULY COLLABORATIVE WAY.” Business Performance Leader, Global R&D Processes and Operations Leader at this Biopharmaceutical Company