(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)
78,685 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, Dr. Jim McNally chats with DMPK Senior Director Dr. David Johnson, Ph.D., from BioAgilytix
Share This 
Chimeric Antigen Receptor (CAR)-T cell therapy is a novel cancer therapy that harnesses and redirects the cytotoxic activity of T
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 
Durham, NC, August 17, 2022 – BioAgilytix Labs, LLC (BioAgilytix), a leading contract research organization supporting pharmaceutical and biotech partners in
Share This 
Durham, NC, July 21, 2022 – BioAgilytix Labs, LLC (BioAgilytix) has secured a valuable seal of approval for the safety of
Share This Chimeric Antigen Receptor (CAR)-T cell therapy is a novel cancer therapy that harnesses and redirects the cytotoxic activity of T
Share This 
Production and sale of therapeutic drugs requires tight control over the manufacturing, processing, and labeling of these products to ensure
Share This 
Incurred sample reanalysis (ISR) is a well-established measure for the reproducibility of pharmacokinetic (PK) assays and commonly conducted in regulated
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)
78,685 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, Dr. Jim McNally chats with DMPK Senior Director Dr. David Johnson, Ph.D., from BioAgilytix
Share This Chimeric Antigen Receptor (CAR)-T cell therapy is a novel cancer therapy that harnesses and redirects the cytotoxic activity of T
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 Durham, NC, August 17, 2022 – BioAgilytix Labs, LLC (BioAgilytix), a leading contract research organization supporting pharmaceutical and biotech partners in
Share This Durham, NC, July 21, 2022 – BioAgilytix Labs, LLC (BioAgilytix) has secured a valuable seal of approval for the safety of
Share This Chimeric Antigen Receptor (CAR)-T cell therapy is a novel cancer therapy that harnesses and redirects the cytotoxic activity of T
Share This Production and sale of therapeutic drugs requires tight control over the manufacturing, processing, and labeling of these products to ensure
Share This Incurred sample reanalysis (ISR) is a well-established measure for the reproducibility of pharmacokinetic (PK) assays and commonly conducted in regulated
Share This
The complete suite of assays & services needed to detect and characterize responses to novel Viruses.
Speak to our scientists to get your testing underway today. Call us directly at +1 919-381-6097 or complete this request form.
As experts in clinical assays, BioAgilytix delivers robust data sets and comprehensive data interpretation beyond what a typical diagnostic lab can offer.
We also offer the breadth of testing needed to determine disease state, characterize antibody response, and assess biomarkers related to novel viruses.
Our assays are helping the global pharma & biotech community address the immediate threats of novel viruses with new vaccine and anti-viral therapeutic programs, and also look ahead at how patients with antibodies to these viruses might impact and change clinical trial strategies moving forward.
We specialize in assays for clinical trials, so our results will stand up to stringent regulatory submission requirements.
Our Boston, MA and Durham, NC labs can perform testing under CLIA to support patient enrollment in clinical trials.
We’re able to tailor our testing strategies to your unique program, and can support development of de novo assays.
BioAgilytix uses the RT-PCR assay with Emergency Use Authorization (EUA) by the FDA to specifically detect the RNA of novel viruses to identify active or recent infections.
pcr testing for novel viruses
Our PCR testing can be applied under CLIA for:
— Diagnostic/ Screening Tests
— Assisting Companies in Starting & Restarting Clinical Trials
BioAgilytix’s highly specific immune response assays detect IgA, IgM, and IgG antibodies to identify individuals who were infected and have already recovered from novel viruses.
Emerging data suggests that CRS in patients with severe cases of novel viruses may cause death. BioAgilytix can apply our validated MSD cytokine/chemokine panels to quantify these biomarkers in patients receiving novel therapeutics for the treatment of these viruses.
These panels have undergone full bioanalytical validation at BioAgilytix and are already utilized to support a broad range of clinical trials today.
Using our Biacore™ T200 platform, we are also able to assess immune response as well as characterize isotype switching to distinguish fresh infection from later infection and determine antibody affinities to define antibody maturation.
Biacore is available at our European lab in Hamburg, Germany and with it we are able to conduct highly specific analysis with efficient time-to-result.
We’re committed to applying our specialized expertise and proven processes to help our customers test for and understand the impacts of novel virus diseases. And with fully operational labs, we’re ready to help today.
To discuss your program requirements, contact your BioAgilytix representative or reach out to us and we’ll connect you to the appropriate scientists to get started.
US: +1 919-381-6097 | Europe: +49 40 526779 0
Tell us a little more about your needs for testing related to novel virus infections and its diseases. We’ll get back to you right away to discuss how we can help.
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
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