(Automated Immunoassays)
(MSD-Multiplex ECLIA)
(SPR Biomarker Interactions)
(ImmunoCAP)
(Western Blot Imager)
(Immune Cell Cytokine Release)
(Low Volume Automated ELISA)
(Multiplex Immunoassay)
SAN DIEGO LAB
34,000 Square Feet
CRO
Immunoassay
Mass Spectrometry
USA HQ (DURHAM)
89,109 Square Feet
Discovery
Preclinical/clinal
Manufacturing
BOSTON LAB
26,453 Square Feet
Bioanalytical Services
Diagnostic Testing
EUROPEAN HQ (HAMBURG)
2,777 Square Meters
Assay Development
Validation
Sample Analysis
Global Disease Studies
MELBOURNE LAB
2,777 Square Meters
Pharmacokinetics (PK)
Pharmacodynamics (PD)
Virology
Immunology
FIH trials & early-phase clinical trials
Central laboratory services
BRISBANE LAB
1,566 Square Meters
Pharmacokinetics (PK)
Pharmacodynamics (PD)
Virology
Immunology
FIH trials & early-phase clinical trials
Central laboratory services
Explore the capabilities of each platform in more detail to learn which option will be best for your unique study. Our team is available for specific guidance on platform selection.
On this episode of Molecular Moments, Lynn Kamen, Ph.D., and Michelle Miller, Ph.D. DABT discuss their very different journeys to
Share This 
As therapeutic drugs have grown in complexity, so too have the bioanalysis techniques to support these products. Bioanalysis of small molecule
Share This 
Summary Jim McNally’s article, ‘Overcoming bioanalytical hurdles in the pharma and life sciences sector,’ is now available in Manufacturing Chemist magazine: Click
Share This 
Summary In an article published by Pharmaceutical Technology Europe, BioAgilytix BioAgilytix supplies its assay expertise to describe the appropriate analytical
Share This 
78,000 Square Feet of Lab and Office Space Added in the First of a Multi-Phase Expansion Durham, NC, October 19,
Share This 
Durham, NC, August 17, 2022 – BioAgilytix Labs, LLC (BioAgilytix), a leading contract research organization supporting pharmaceutical and biotech partners in
Share This As therapeutic drugs have grown in complexity, so too have the bioanalysis techniques to support these products. Bioanalysis of small molecule
Share This 
Neoantigens are novel proteins that form on cancer cells following the development of mutations in the tumor-cell DNA. These proteins
Share This 
Cytokines are proteins released by activated cells that serve as soluble messengers binding to target cells through surface receptors, signaling
Share This 
(Automated Immunoassays)
(MSD-Multiplex ECLIA)
(SPR Biomarker Interactions)
(ImmunoCAP)
(Western Blot Imager)
(Immune Cell Cytokine Release)
(Low Volume Automated ELISA)
(Multiplex Immunoassay)
SAN DIEGO LAB
34,000 Square Feet
CRO
Immunoassay
Mass Spectrometry
USA HQ (DURHAM)
89,109 Square Feet
Discovery
Preclinical/clinal
Manufacturing
BOSTON LAB
26,453 Square Feet
Bioanalytical Services
Diagnostic Testing
EUROPEAN HQ (HAMBURG)
2,777 Square Meters
Assay Development
Validation
Sample Analysis
Global Disease Studies
MELBOURNE LAB
2,777 Square Meters
Pharmacokinetics (PK)
Pharmacodynamics (PD)
Virology
Immunology
FIH trials & early-phase clinical trials
Central laboratory services
BRISBANE LAB
1,566 Square Meters
Pharmacokinetics (PK)
Pharmacodynamics (PD)
Virology
Immunology
FIH trials & early-phase clinical trials
Central laboratory services
Explore the capabilities of each platform in more detail to learn which option will be best for your unique study. Our team is available for specific guidance on platform selection.
On this episode of Molecular Moments, Lynn Kamen, Ph.D., and Michelle Miller, Ph.D. DABT discuss their very different journeys to
Share This As therapeutic drugs have grown in complexity, so too have the bioanalysis techniques to support these products. Bioanalysis of small molecule
Share This Summary Jim McNally’s article, ‘Overcoming bioanalytical hurdles in the pharma and life sciences sector,’ is now available in Manufacturing Chemist magazine: Click
Share This Summary In an article published by Pharmaceutical Technology Europe, BioAgilytix BioAgilytix supplies its assay expertise to describe the appropriate analytical
Share This 78,000 Square Feet of Lab and Office Space Added in the First of a Multi-Phase Expansion Durham, NC, October 19,
Share This Durham, NC, August 17, 2022 – BioAgilytix Labs, LLC (BioAgilytix), a leading contract research organization supporting pharmaceutical and biotech partners in
Share This As therapeutic drugs have grown in complexity, so too have the bioanalysis techniques to support these products. Bioanalysis of small molecule
Share This Neoantigens are novel proteins that form on cancer cells following the development of mutations in the tumor-cell DNA. These proteins
Share This Cytokines are proteins released by activated cells that serve as soluble messengers binding to target cells through surface receptors, signaling
Share This
The recent approval of Zynteglo further builds credibility to the specific and emerging class of cell therapies engineered via “ex vivo” gene therapy. We explain how these cell-based gene therapies work, and how they lend themselves to a host of translatable techniques for future therapeutic candidates.
A contributing author to the Critical Path Institute (C-Path)’s “Points to Consider Document,” Dr. Afshin Safavi summarizes considerations outlined in the paper designed to establish consensus on the expectations for the validation of assays used in the regulatory qualification of fluid biomarkers.
Share This 
Last month at WRIB, our scientific team had the opportunity to participate in a number of discussions surrounding the latest topics of interest in biomarkers, immunogenicity, and regulatory standards. We wanted to share some of the event takeaways we found most interesting and valuable.
Share This 
BioAgilytix’s President and CEO, Jim Datin, sat down to discuss the exciting growth trends in large molecule development, and how BioAgilytix is growing in kind to support the increased need for specialized bioanalysis to accelerate these innovative therapies to market.
Share This 
By Dr. Arno Kromminga and Dr. Lydia Michaut
Gene therapy has experienced an exciting resurgence in the post-genomic era, but unwanted immunogenicity is still a concern. Our latest blog gives insight into the current concepts for designing an immunogenicity assessment strategy fitting the specific needs of a given gene therapy compound.
Share This 
The FDA’s recently released new guidance, designed to facilitate development and validation of assays for the detection of anti-drug antibodies for immunogenicity testing, includes several needed revisions and clarifications. Our own immunogenicity expert, Dr. Arno Kromminga, outlines the significant updates made.
Share This 
Couldn’t make the Oxford Global’s 14th Annual Biomarkers Congress? Read our recap of the key opportunities and challenges in biomarker development that scientists discussed.
Share This 
We find it critical to stay on top of the latest industry developments to inform our own work and help our customers best address emerging bioanalytical challenges and opportunities; we’ve compiled some of our favorite recent industry articles of interest to share with you.
Share This 
The FDA has observed an unprecedented increase in the number of cell and gene therapy products entering the early stages of development. In a recent statement, the agency outlined new planned policies to help accelerate these innovations through the pipeline to clinical success. We discuss what this announcement means to sponsors.
Share This 
We are privileged to be working in collaboration with representatives of the Prion Alliance at the Broad Institute, on the development of a Prion ELISA. Why would we include this story in our blog? Well, it is because two aspects of this project are noteworthy; read on.
Share This 2300 Englert Dr
Durham, NC, 27713
919-381-6097
Fax 919-381-6099
9050 Camino Santa Fe
San Diego, CA 92121
858-652-4600
Fax 858-652-4699
37 Kent St, Woolloongabba
Queensland, 4102, Australia
2300 Englert Dr
Durham, NC, 27713
919-381-6097
Fax 919-381-6099
9050 Camino Santa Fe
San Diego, CA 92121
858-652-4600
Fax 858-652-4699
37 Kent St,Woolloongabba
Queensland, 4102, Australia
1320 Soldiers Field Road
Boston, MA, 02135
617-456-0700
Fax 617-456-0701
1320 Soldiers Field Road
Boston, MA, 02135
617-456-0700
Fax 617-456-0701
Lademannbogen 10
22339 Hamburg Germany
+49 405267790
85 Commercial Road, Melbourne
Victoria, 3004, Australia
+61 3 9282 2184
Lademannbogen 10
22339 Hamburg Germany
+49 405267790
85 Commercial Road, Melbourne
Victoria, 3004, Australia
+61 3 9282 2184
Copyright © 2022 BioAgilytix Labs.
All rights reserved.
