Simplify Sample Management and Accelerate Discoveries

FROM DISCOVERY THROUGH Supporting customers across the sample management spectrum DRUG DEVELOPMENT PEACE OF MIND Partnering with a leader in sample exploration and management allows you to transcend the tedious parts of your projects with access to a full suite of proven cold-chain sample management solutions and multiomic services that enable operational efficiency, simplify workflows, and empower organizations to control labs with confidence. This collection of case studies highlights how Azenta Life Sciences partners with our clients to aid in every step of the sample management workflow, so you can focus on your research and bring impactful breakthroughs and innovative therapies to market with greater speed and precision. COMES FROM KNOWING YOUR PRECIOUS SAMPLES ARE TAKEN CARE OF. SUPPORTING CUSTOMERS ACROSS THE SAMPLE MANAGEMENT SPECTRUM | 3 1 Planning 2 Sample collection 3 Sample transportation 4 Sample annotation 5 Sample storage 6 Pre-analytical services 7 Sample analysis & multiomics REPEAT Analysis planning Collection planning Sample workflows Sample collection kit design Sample collection kit production & distribution Storage tubes & microplates CryoPodTM Mobile repository service Logistics management Barcode reading systems Patient consent annotation Sample blinding Cold chain data Informatics solutions Automated stores Cryogenic storage (manual and automated) Storage at Azenta or at customer site Sample discard services Sample retrieval Automated aliquoting Sample reformatting Nucleic acid extraction Cell isolation and cryopreservation Custom processing protocols Biomarker discovery & profiling Genomics Transcriptomics Epigenomics Proteomics Bioinformatics Comprehensive solutions for complete confidence SUPPORTING CUSTOMERS ACROSS THE SAMPLE MANAGEMENT SPECTRUM | 4 1 2 3 4 6 7 5 Sample storage CLICK HERE FOR THE FULL CASE STUDY Impact of Quick Sample Retrieval on Clinical Study Outcomes 1 A leading biopharmaceutical company faced logistic challenges when storing their clinical samples long-term at central and specialty laboratories and external biorepositories. When researchers attempted to retrieve thousands of specimens for FDA-mandated biomarker testing for a phase 3 study that had to be submitted within a couple of business days, they faced lengthy turnaround times of up to several weeks. This significantly impacted the outcome of the study and potentially affected their investigational new drug application acceptance. THE CHALLENGE THE SOLUTION Azenta facilitated rapid clinical sample retrieval and shipment to the client and analyzing lab, thus accelerating these clinical studies, and significantly increasing the speed of the drug’s arrival to market. The integrated sample management solution provided by Azenta enables rapid clinical sample retrieval and shipment to anywhere in the world, with retrieval time as fast as 24-48 hours. The speed of sample logistics is complemented by our comprehensive reporting system that provides full visibility into dates and times when samples are registered, stored, shipped, or discarded. Azenta also offers the necessary genomics, transcriptomics, and proteomic assays to further accelerate retrieval through data. THE RESULTS By adopting an integrated sample management approach with Azenta, the client gained: Prompt sample retrieval and delivery Rapid study data resolution Swift approval of therapeutics Faster drug-to-market turnaround SUPPORTING CUSTOMERS ACROSS THE SAMPLE MANAGEMENT SPECTRUM | 5 1 2 3 4 5 6 7 Sample analysis & multiomics CLICK HERE FOR THE FULL CASE STUDY Producing and Protecting a 2 Monoclonal Antibody Library Researchers at a top pharmaceutical company needed to produce over twenty monoclonal antibodies as part of their antibody discovery process. DNA constructs had to be synthesized and expressed to generate five to six mg of human IgG protein at high concentration while maintaining low endotoxin levels for downstream applications. The antibodies had not been previously produced, so expected expression levels were unknown. THE CHALLENGE THE SOLUTION Azenta Life Sciences used its gene-to-antibody workflow for recombinant antibody production to generate the samples of this library. The variable regions of the antibody DNA sequences were synthesized and cloned into an expression vector provided by the customer. The constructs were verified by Sanger sequencing, and maxi-scale endotoxin-free preparations of the plasmid DNA were generated. Each antibody was transiently expressed and protein levels in the supernatant were evaluated by biolayer interferometry (BLI) using the Octet® platform. Single-step affinity chromatography purification was performed, and purity was assayed by SDS-PAGE. For those working on discovery assays, Azenta also offers optional storage of antibody production sets and can provide a protected environment to maintain sample integrity over the course of the project. THE RESULTS Through this optimized antibody sample process provided by Azenta, the client achieved: Reduced project time and cost from BLI analysis to remove low or non-expressing samples from this novel antibody library Their challenging goal of low endotoxin levels at high protein concentration for downstream applications A protein purity of 89% or higher for all antibodies, exceeding the yield requirements for future work SUPPORTING CUSTOMERS ACROSS THE SAMPLE MANAGEMENT SPECTRUM | 6 CLICK HERE FOR THE FULL CASE STUDY 3Ultra-Low Cold Chain Management to Support a Vaccine Manufacturer Azenta was approached by a leading global clinical and commercial contract development manufacturing organization (CDMO) to manage the cold chain logistics for the production of a COVID-19 vaccine. Due to the increasing need for a vaccine during the pandemic, this client faced cold storage capacity and logistic constraints. The vaccine maker was under intense pressure to increase production and was looking for a partner to accelerate output during a crisis. THE CHALLENGE THE SOLUTION The client partnered with Azenta for cold chain logistical support at their site and utilized our cold storage units and experts to support their vaccine manufacturing and storage 24/7. The client delivered around 9 million vaccines in four months and is continuing to roll out more with our support. Overall, our client rose to the challenge of increasing the manufacturing of their vaccine to meet the heightened demand. The Azenta team’s expertise in cold chain management and ability to handle the logistical requirements during a pandemic helped make this possible. THE RESULTS The client was able to achieve: Cold chain storage and management of raw materials and finished products Increased operational speed Manufacturing scale-up Uninterrupted vaccine production 1 2 3 4 6 7 5 Sample storage SUPPORTING CUSTOMERS ACROSS THE SAMPLE MANAGEMENT SPECTRUM | 7 CLICK HERE TO EXPLORE GLP AAV-ITR SANGER SEQUENCING SOLUTIONS Enhancing Sample Annotation with Quality Control Documentation 4and Product Release Through Viral Genome Sequence Confirmation A biotechnology company needed the assistance of an established GLPvalidated workflow to confirm the integrity of highly complex samples from viral stocks at different stages of production, including master viral stock, working viral stocks, and final products (viral particles). THE CHALLENGE THE SOLUTION Azenta provided third-party quality control checks by conducting new and repeat testing of various sequences, including inverted terminal repeat (ITR) regions. The client utilized our GLP-grade confirmatory workflow with proprietary AAV-ITR sequence technology for thorough sequencing. Enabled by the sample management infrastructure and expertise provided by Azenta, the final report, and certificate of analysis (COA) documents of each project are then used for quality control documentation, lot release testing, and product identity confirmation. THE RESULTS By partnering with Azenta for confirmatory workflow solutions, this company has benefitted from: Continued support of several Azenta GLP-compliant services for their projects Proprietary ITR sequencing technology Faster turnaround times Enhanced sample annotation through quality control documentation 1 2 3 4 5 6 7 Sample analysis & multiomics SUPPORTING CUSTOMERS ACROSS THE SAMPLE MANAGEMENT SPECTRUM | 8 Rigor, Control, and Process Excellence in 5Cryogenic Biobanking from the First ISO-Accredited Biobank CLICK HERE FOR THE FULL CASE STUDY The biggest challenge in successfully running a biobank is identifying the right tools and technology. Our client from Cornell Veterinary Biobank, the first ISO 20387 accredited biobank, was looking for supplies and equipment to help improve their processes, as well as technological advances that would assist in QA and ISO standard compliance. They were also interested in how innovative equipment and supplies can be integrated into the collection, cryopreservation, transportation, and storage process improvements. THE CHALLENGE THE SOLUTION The biobank client took advantage of automation technology for biological material storage and retrieval from Azenta Life Sciences, which improved the client’s biological material and associated data quality, security, cold chain integrity, and traceability. The BioStoreTM automated LN₂ freezer eliminated personnel exposure to liquid nitrogen, as compared to manual rack removal. Personnel safety and retention also improved because the automation system lessens workloads and automatically fills the freezer to pre-set levels. The client’s samples are secure due to password protection to access automation software for sample access or inventory viewing. Complete audit trail tracking has improved the traceability of samples and the storage process. Another important piece of Azenta equipment at the client’s location is the CryoPodTM. Once charged, the CryoPod carrier temperature stays below the glass transition phase for at least four hours. Utilizing the CryoPod with automation technology preserves the cold chain integrity of samples during storage or removal. This prevents temperature excursions that could adversely affect the quality of the samples. THE RESULTS Automation and inventory management software improved storage and distribution processes. Automation technology drives biobank sustainability and adaptation to dynamic situations such as supply chain disruptions or other emergencies. With this equipment from Azenta Life Sciences in place, the client benefits from the following: Maintained temperature for 21 days without the use of electricity for filling via the BioStore Improved traceability which enhances QC Accreditation to improve stakeholder acceptance for sustainability 1 2 3 4 6 7 5 Sample storage Having the right tools and technology to strengthen your sample management processes enables your team to be safer, more efficient, and more focused on the research that counts. From storage to analysis, retrieval, and future processing, customers have accelerated discovery, development, and delivery with the proven cold-chain sample management solutions and genomics services provided by Azenta Life Sciences. Explore the full workflow of sample management and automation solutions offered by Azenta, and learn how our services and products can be customized to support your projects. EXPLORE SAMPLE MANAGEMENT SOLUTIONS © 2024 Azenta US, Inc. All rights reserved. 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