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.
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.
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.
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.
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.
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).
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
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.
By the Numbers
Size and scale to meet demands, around the world
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…
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. …
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.
“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
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.
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
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 innovation. Working cross-functionally and collaborating makes my role fun and exciting at BioAgilytix.Shashank Gorityala, Ph.D
Associate Director, LC/MS Bioanalysis
My fascination with blood and lymphatic vessels led me to research their genetic make-up and related diseases, in hopes to find potential drug targets. During my research I trained extensively in cell-based work including but not limited to gene expression studies, intracellular signaling, cellular staining, transduction, all of which helped me build a strong foundation of transferable skills.Reema Davis
Manager I, Operations