About BioAgilytix
About Bioagilytix

Your Partner for Large Molecule Bioanalysis

Delivering Premier Science, Deep Experience, and Proven Quality

BioAgilytix’s global team of highly experienced scientific and QA professionals deliver world-leading science, proven data integrity, and deep regulatory expertise to support all phases of large molecule global studies. Today we provide comprehensive GxP services to innovators all over the world, including 23 of the top 25 global pharmaceutical and biotech companies.

So what makes BioAgilytix the bioanalytical lab of choice for pharma and biotech companies looking to achieve more for the patients they serve?

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What are your specific assay needs? If you have questions or would to like discuss your specific assay needs, we will put you directly in touch with a member of our scientific team.

Passionate About the Science Behind Therapeutic Innovation

Our passion for the science of large molecule bioanalysis drives our ability to deliver premium, tailored services for biomarker, immunogenicity, pharmacokinetics (PK), and cell-based assays. We are as committed as our customers to advancing new biologic products that can change and save lives, and we support these efforts by helping them navigate the complex scientific and regulatory challenges inherent in the bioanalytical testing of these drugs. Our specialization helps us remain uniquely focused on delivering best-in-class science for virtually any large molecule need.

A large part of upholding premium science involves keeping on the pulse of industry shifts, and understanding how new assay and technology innovations can optimize and accelerate our own work. That is why you’ll see our scientists actively involved in industry associations, gathering and contributing perspectives at events, and publishing content that is helping to evolve thinking and drive new advancements in bioanalysis.

 

Our Latest Thinking

cell based assays keep biosimilars on track

Cell-Based Assays Keep Biosimilars on Track

 

therapeutic human cancers

Innovative Therapeutic Options for Treating Human Cancers

 

biosimilars development

Large Molecule Experience That Runs Deep, Across a Broad Global Team

We are able to provide an unmatched level of premier science because of the depth of scientific expertise within our global leadership team. Each member brings with them decades of in-lab experience supporting diverse large molecule projects through all phases of development. In fact, our European CSO, Dr. Arno Kromminga, is a pioneer in the area of immunogenicity and brought the first biosimilar EPO to approval in Europe. Our USA CSO, Jeff Sailstad, is a world-renowned thought leader in the development and application of bioanalytical methods used in regulatory submissions. Dr. Dominique Gouty, our SVP of Business Operations, is a sought-after subject matter expert in biosimilars, and our Global CSO, Dr. Afshin Safavi, is a recognized expert in the area of immunoassays and is helping to shape the industry narrative on bioanalytical methods for biomarkers.

But our scientific depth doesn’t end at our leadership team. We believe that the only way to maintain the standard of quality that our cutomers expect is by maintaining a ‘deep bench’ – a scientific team that has the breadth and depth of experience required to overcome bioanalytical complexities in any phase of development. That is why our global team averages 15+ years of bench experience, with over 35% Ph.D. / Masters-level scientists. Each brings their own real-world experience in the stringent scientific and quality demands of biologics development to benefit your study.

 

Consultative Support for Global Studies of any Capacity

 

large molecule lab

With large, advanced laboratory locations in North Carolina’s Research Triangle Park area and Hamburg, Germany, BioAgilytix is fully able to support all phases of large molecule global studies, from discovery and preclinical work to Phase I, II, III, and IV trials. Our capacity allows us to handle large molecule projects of any size, including those requiring analysis of a large number of samples.

Each lab is equipped with advanced platform technology and expert staff to ensure efficient, accurate bioanalysis for large molecule projects of any scope.

 

laboratory management processes

While our reach is global, our customer relationships are personal. We take a uniquely consultative approach to project management, working scientist to scientist alongside your internal teams to proactively anticipate assay challenges, recommend solutions, and identify every possible opportunity to compress your timelines and time to market. Our industry-leading employee retention rate and collaborative approach enables us to deliver exceptional customer service and full transparency into project status at every stage of development.

 

Committed to Delivering for our customers, always

As a team, we don’t just talk about quality; we embody it. Our sustainable Quality Management System (QMS) is built on four key pillars: customer understanding; performance and reliability; regulatory compliance; and ownership and accountability. These foundational elements drive everything we do, so that we can deliver robust, reliable results to our customers, on time, the first time.

With a GLP / GMP lab in USA and a GLP certified lab in Europe, our ability to uphold regulatory quality standards is proven; but these standards alone are not necessarily sufficient in defining the kind of advanced quality that is demanded in the complex bioanalytical projects and applications we support. Therefore our veteran QA team has established additional procedures to ensure quality permeates every aspect of our operations, from data integrity to safety, responsibility, and innovation. In addition to the robust systems and processes we have in place – such as LIMS, cross training for our global teams, backup labs for BCP, and more – we foster a culture of quality among our entire team, so our customers experience quality in every interaction they have with us.

 

quality management ystem

Ready to help you achieve more

Our differentiated approach helps up uphold the level of science, service, and quality required for effective large molecule bioanalysis. Don’t settle for missed deadlines, unreliable data, or anything less than the best science. Get it right the first time with BioAgilytix’s help, and accelerate your development efforts to get life-changing, life-saving biotherapeutics to the patients that need them, faster.

 

“With BioAgilytix, I know that I am working with veteran scientists capable of solving my toughest problems.”

– Director of PK/Immunogenicity, Top 5 Pharma

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