(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 sq. ft.
CRO
Immunoassay
Mass Spectrometry
USA HQ (DURHAM)
~265,000 sq. ft.
Discovery
Preclinical/clinal
Manufacturing
BOSTON LAB
~22,000 sq. ft.
Bioanalytical Services
Diagnostic Testing
EUROPEAN HQ (HAMBURG)
~2,900 m2 (31,000 sq. ft.)
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, Jim McNally, Ph.D., speaks with Adam Stasio, president of SciMed, whose mission is to
Share This 
The third and final blog in our cell and gene therapy series will focus on PCR as a bioanalytical tool
Share This 
In this article, Chief Scientific Officer at BioAgilytix, Jim McNally, Ph.D., explores why bioanalysts should prepare for the impending wave
Share This 
Once the patent on a previously ground-breaking blockbuster molecule comes to an end, there is an opportunity for biosimilar versions
Share This 
A3P Biomedical AB, a Swedish company specialized in advanced prostate cancer diagnostics, and BioAgilytix, a global bioanalytical services provider, have
Share This 
BioAgilytix Commits to United Nations Global Compact Leading bioanalytical services provider pledges to act in support of human rights
Share This The third and final blog in our cell and gene therapy series will focus on PCR as a bioanalytical tool
Share This 
An Overview of Cell Therapy: As we continue our blog series on cell and gene therapy, we will now dive
Share This 
An Introduction to Gene Therapy: As early as the 1970’s, the term “gene therapy” was used for the treatment of
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 sq. ft.
CRO
Immunoassay
Mass Spectrometry
USA HQ (DURHAM)
~265,000 sq. ft.
Discovery
Preclinical/clinal
Manufacturing
BOSTON LAB
~22,000 sq. ft.
Bioanalytical Services
Diagnostic Testing
EUROPEAN HQ (HAMBURG)
~2,900 m2 (31,000 sq. ft.)
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, Jim McNally, Ph.D., speaks with Adam Stasio, president of SciMed, whose mission is to
Share This The third and final blog in our cell and gene therapy series will focus on PCR as a bioanalytical tool
Share This In this article, Chief Scientific Officer at BioAgilytix, Jim McNally, Ph.D., explores why bioanalysts should prepare for the impending wave
Share This Once the patent on a previously ground-breaking blockbuster molecule comes to an end, there is an opportunity for biosimilar versions
Share This A3P Biomedical AB, a Swedish company specialized in advanced prostate cancer diagnostics, and BioAgilytix, a global bioanalytical services provider, have
Share This BioAgilytix Commits to United Nations Global Compact Leading bioanalytical services provider pledges to act in support of human rights
Share This The third and final blog in our cell and gene therapy series will focus on PCR as a bioanalytical tool
Share This An Overview of Cell Therapy: As we continue our blog series on cell and gene therapy, we will now dive
Share This An Introduction to Gene Therapy: As early as the 1970’s, the term “gene therapy” was used for the treatment of
Share This
The concept of using pre-existing immunogenicity as an exclusion criteria for gene therapy clinical trials is changing. BioAgilytix’s Chief Scientific Officer, Dr. Jim McNally, explores why.
Share This 
The webinar I recently hosted with my colleague Lydia Michaut explored key challenges and trends in the immunogenicity assessment of gene therapy compounds. This recap highlights the critical questions that were answered.
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.
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Today we’re featuring a case study on how BioAgilytix developed a cell-based assay to determine the prevalence of pre-existing antibodies against the AAV9 serotype in patients for a gene therapy clinical trial.
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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.
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Unlike small-molecule drugs, large molecule therapeutics face a high chance of detection by the immune system, and are therefore more apt to trigger alarms. The resulting immune responses can range from largely benign to life-threatening, which is why immunogenicity testing has become a critical requirement in the biologics development process. But, the development and implementation of such assays can be technically challenging, and this is causing differing industry opinions around
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The whitepaper based on discussions at the 10th Workshop on Recent Issues in Bioanalysis (WRIB) has been published! Everyone who participated, are very excited to share the knowledge of industry leaders and regulators that was aggregated during the weeklong event. This year’s WRIB was quite a successful event. Close to 700 industry leaders from biopharmaceutical and biotechnology companies, CROs, and regulatory agencies gathered in Orlando, Florida to share, review, and
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 © 2023 BioAgilytix Labs.
All rights reserved.
2300 Englert Dr
Durham, NC, 27713
919-381-6097
Fax 919-381-6099
5927 S. Miami Blvd. Suite 100
Morrisville, NC 27560
919-381-6097
Fax 919-381-6099
1320 Soldiers Field Road
Boston, MA, 02135
Office 617-456-0700
Fax 617-456-0701
9050 Camino Santa Fe
San Diego, CA 92121
858-652-4600
Fax 858-652-4699
Lademannbogen 10
22339 Hamburg Germany
+49 405267790
37 Kent St, Woolloongabba
Queensland, 4102, Australia
85 Commercial Road, Melbourne
Victoria, 3004, Australia
03 9282 2184
Copyright © 2023 BioAgilytix Labs.
All rights reserved.
Terms of Use | Privacy Notice
2300 Englert Dr
Durham, NC, 27713
919-381-6097
Fax 919-381-6099
5927 S. Miami Blvd. Suite 100
Morrisville, NC 27703
919-381-6097
Fax 919-381-6099
1320 Soldiers Field Road
Boston, MA, 02135
617-456-0700
Fax 617-456-0701
9050 Camino Santa Fe
San Diego, CA 92121
858-652-4600
Fax 858-652-4699
Lademannbogen 10
22339 Hamburg Germany
+49 405267790
37 Kent St,Woolloongabba
Queensland, 4102, Australia
85 Commercial Road, Melbourne
Victoria, 3004, Australia
03 9282 2184
Copyright © 2023 BioAgilytix Labs.
All rights reserved.
