(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
When developing biosimilar drugs, it is critical to demonstrate biosimilarity to the originator drug including similarities of physical and chemical properties as well as Pharmacokinetic (PK) analyses.
This webinar will summarize the recommendations from the AAPS Ligand Binding Assay Biosimilar subcommittee and Biosimilars Action Program Committee on the Development and Validation of PK, Anti-Drug Antibody (ADA), and Neutralization Antibody Assays (NAB) for Biosimilar Drug Development and will describe how this information can be used to reduce the risks present in biosimilar drug development.
We will also discuss the recently released FDA guidance, “Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product”, and its implications for clinical pharmacology studies for proposed biosimilar products.
This webinar is now available for on-demand viewing. Watch the recording for a limited time!
Senior Vice President of Business Operations
Dr. Dominique Gouty has over 20 years of industry experience spanning R&D, clinical operation, and manufacturing, and is a leading expert in key subjects concerning preclinical and clinical bioanalysis for novel therapeutic biologics and biosimilars.
Senior Vice President and European CSO
Dr. Arno Kromminga is a certified specialized immunologist with 20+ years expertise covering the entire cascade of assay strategy and characterization of immune responses against biological therapeutics. A pioneer in the area of immunogenicity, his laboratory brought the first biosimilar EPO to approval in Europe and supported the first biosimilar EPO submission in the U.S.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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All rights reserved.
