go.bioagilytix.comBioAgilytix | Global Leader for Bioanalytical Services

BioAgilytixNewsroom Off-the-Shelf Assay Menu Speak to a Scientist Search Solutions Show submenu Phases Show submenu Discovery Preclinical Clinical CMC Bioanalytical Modalities Show submenu Large Molecules Small Molecules Advanced Therapies (ATMP) Vaccines Services Show submenu Drug Metabolism Pharmacokinetics Pharmacodynamics Immunogenicity Biomarkers CMC Bioanalytical Diagnostic Testing Capabilities Show submenu Method Transfer Assay Creation Sample Analysis Kit Production Diagnostic Testing Off-the-Shelf Assays Techniques & Platforms Show submenu Techniques Show submenu Ligand Binding Assay / Immunoassay Cell-based Assays Virology Molecular Assays Mass Spectrometry Instrumentation Show submenu MSD PCR Luminex LI-COR Protein Simple Ella Biacore ELISpot Plate Readers Roche Cobas Analyzer ImmunoCAP Gyrolab LC/MS Flow Cytometers Lab Automation Systems Quality Systems Therapeutic Focus Scientific Expertise Show submenu Publications Posters Scientific Insights Scientific Office Project Management About Show submenu Who We Are ESG Quality Commitment Careers Executive Leadership Locations Newsroom Events Australian Advantage Partners The Trusted Partner for Bioanalytical Science and Services BioAgilytix is the partner trusted most by leading biopharma organizations for our unrivaled track record, regulatory expertise and industry leadership at every stage of the drug development process. With more than 30 years of experience, we excel in the most demanding areas of bioanalysis where extensive, expert-level scientific skill is required, and service excellence is expected. Explore Our Services Speak to a Scientist Capabilities icons_Cell Culture Method Transfer Streamlined processes for successful method transfers Look to BioAgilytix for proven method transfer and data integrity practices that control quality and help ensure reproducible assay performance during drug development. Explore Our Method Transfer Capabilities icons_Fermentation Assay Creation Customized method development and validation for your bioanalytical needs Work with BioAgilytix to create custom assays tailored to your bioanalytical considerations and relevant regulatory requirements. We provide de novo assay development, partial validations, cross-matrix validations, GxP-compliant validations, or any combination of these required to meet your bioanalytical needs in a fit-for-purpose manner. Explore Our Assay Creation Capabilities icons_DNA Sample Analysis On-time, accurate, and high-quality sample analysis results during preclinical and clinical testing Place your trust in BioAgilytix with our proven track record of delivering quality data that can withstand regulatory scrutiny in a timely fashion. We understand that each sample is highly valuable and nothing is as important as on-time, accurate, and high-quality sample analysis results during preclinical and clinical testing. Explore Our Sample Analysis Capabilities icons_Clinical Kit Production Customized specimen collection kits for clinical trials Take advantage of BioAgilytix’s end-to-end support for specimen collection, including lab manuals, the specimen collection kits themselves, logistics, and shipment tracking to destinations across the globe. We assemble and distribute protocol-specific kits for all types of clinical trials, including single-site, multi-site, and Phase I-IV. Explore Our Kit Production Capabilities icons_Commercial Diagnostic Testing Expedient analysis, accurate results, and customized reporting to fit turnaround times Partner with BioAgilytix as your key service provider for specialized biomedical diagnostic testing services for infectious diseases, diagnostic immunology, vitamin testing, parasite-borne infection testing, and Laboratory Developed Tests (LDTs). Explore Our Diagnostic Testing Capabilities e90705a19d9adffefcb1ed13f6fb3db8 Off-the-shelf Assays Faster timelines and reduced costs for regulated or nonregulated sample analysis Utilize one of BioAgilytix’s off-the-shelf assays to expedite your bioanalytical project. Creating and validating de novo assays for phase-appropriate use takes a significant amount of time. Having off-the- shelf assays in place and ready to use for regulated or nonregulated sample analysis directly translates into faster timelines and reduced costs, two critical aspects of designing successful preclinical and/or clinical studies. EXPLORE OUR OFF-THE-SHELF ASSAY CAPABILITIES AND MENU Our Approach Scientist to scientist. Sharing knowledge. Minimizing risk. We take a uniquely consultative approach to every project. Leveraging the industry’s most complete set of capabilities and expert resources, our scientists working with your scientists to proactively anticipate assay challenges and keep you on track. Our expertise, regulatory track record, focus on quality and continuity of scientific oversight, avoiding costly delays, so your therapeutic advancements get to market sooner. How can we help with your Project By the Numbers Size and scale to meet demands, around the world 67 -DNA- (science, laboratory, research, outline) Created with Sketch. 30+ Years Experience 026 – Globe Created with Sketch. 3 Continents | 6 Locations 017 – People Puzzle Created with Sketch. 1,000+ Employees and Growing Scientific Insights View all insights Webinar eChalk Talk: CMC Bioanalytical Control for ATMPs-Challenges and Strategies Sr. Director of CMC Bioanalytical Services, Jeff Patrick, PhD, and Scientific Officer, Michelle Miller, PhD, provide an overview of considerations in the development and lifecycle… Read More Webinar Bioanalytical Challenges For Cellular Immunogenicity Testing Using Validated ELISpot Assays Advanced modalities do not easily lend themselves to the standard approaches for quantitating drug product as small and large molecule therapeutics do. Technologies such as… Read More Blog PCR as a Bioanalytical Tool for Gene and Cell Therapy The third and final blog in our cell and gene therapy series will focus on PCR as a bioanalytical tool for gene and cell therapy. … Read More Our Customers Are Our Biggest Advocates We’re proud to be regarded as a valued partner to our clients – including some of the top global pharmaceutical and biotech companies, rising biotechs, and innovative leaders in industries like agricultural biotechnology. Having seen the result of our work firsthand, our customers are the best source of knowledge on what it’s like when you partner with BioAgilytix. Previous Next In the end, I am most interested in quality results. With BioAgilytix, I know that I am working with veteran scientists capable of solving my toughest problems.” -Director Of PK/Immunogenicity, Top 5 Pharma BioAgilytix has repeatedly exceeded our expectations. This is really no surprise given the quality and experience level of their scientists.” -Head Of Biomarker Development, Top 10 Pharma Working with BioAgilytix removes the guess work. I always know the status of my project because their team of senior scientists communicates regularly.” -Clinical Manager, Top 5 Pharma The veteran scientists at BioAgilytix promote continuous communication and collaboration. I am always confident that my projects will be completed successfully.” – Head Of Bioanalytical Development, Top 10 Biotech Careers Play a vital role supporting tomorrow’s biotherapeutic breakthroughs. Bioanalysis is a critical upfront activity in drug development. As recognized leaders in the field, we help our sponsor partners create the therapies that will transform patient care. Previous Next Working here at BioAgilytix instills a sense of pride- I know that I’m helping patients all around the world receive life-saving therapies, while doing what I love in the lab. It’s the best feeling! Lauren Scheetz Scientist 1 BioAgilytix prioritizes career growth and strong science, and working for such an organization is an empowering experience. The leadership team values individual aspirations, fostering a culture of continuous improvement and...