
[EPISODE 25] Adam Stasio Talks, Large Data Sets, Breaking Down Problems, and Tech-Driven Solutions
On this episode of Molecular Moments, Jim McNally, Ph.D., speaks with Adam Stasio, president of SciMed, whose mission is to
(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
The third and final blog in our cell and gene therapy series will focus on PCR as a bioanalytical tool
In this article, Chief Scientific Officer at BioAgilytix, Jim McNally, Ph.D., explores why bioanalysts should prepare for the impending wave
Once the patent on a previously ground-breaking blockbuster molecule comes to an end, there is an opportunity for biosimilar versions
A3P Biomedical AB, a Swedish company specialized in advanced prostate cancer diagnostics, and BioAgilytix, a global bioanalytical services provider, have
BioAgilytix Commits to United Nations Global Compact Leading bioanalytical services provider pledges to act in support of human rights
The third and final blog in our cell and gene therapy series will focus on PCR as a bioanalytical tool
An Overview of Cell Therapy: As we continue our blog series on cell and gene therapy, we will now dive
An Introduction to Gene Therapy: As early as the 1970’s, the term “gene therapy” was used for the treatment of
(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
The third and final blog in our cell and gene therapy series will focus on PCR as a bioanalytical tool
In this article, Chief Scientific Officer at BioAgilytix, Jim McNally, Ph.D., explores why bioanalysts should prepare for the impending wave
Once the patent on a previously ground-breaking blockbuster molecule comes to an end, there is an opportunity for biosimilar versions
A3P Biomedical AB, a Swedish company specialized in advanced prostate cancer diagnostics, and BioAgilytix, a global bioanalytical services provider, have
BioAgilytix Commits to United Nations Global Compact Leading bioanalytical services provider pledges to act in support of human rights
The third and final blog in our cell and gene therapy series will focus on PCR as a bioanalytical tool
An Overview of Cell Therapy: As we continue our blog series on cell and gene therapy, we will now dive
An Introduction to Gene Therapy: As early as the 1970’s, the term “gene therapy” was used for the treatment of
PEGylation is used to extend half-lives for many new biologics as well as conventional low molecular drugs, and this potent therapeutic had a very long half-life.
Due to environmental exposure, a significant portion of the general population has pre-existing anti-PEG antibodies. In most cases, these antibodies are clinically benign, but there have been occurrences where they play a role in serious adverse reactions upon drug exposure. For that reason, regulatory agencies are requiring the monitoring of anti-PEG prevalence and attenuation upon exposure to PEGylated therapeutics. In this study, BioAgilytix had to assess the immunogenicity of the PEGlayted therapeutic with an approach that could maximize drug tolerance while maintaining high sensitivity.
Clinical phase anti-drug antibody (ADA) assessment for enzyme replacement therapy for a serious unmet medical need.
Monitor anti-PEG prevalence and attenuation upon exposure to PEGylated therapeutics.
Maximize drug tolerance while maintaining sensitivity.
Unconventional and unique projects like this one pose challenges when it comes to meeting evolving regulatory expectations. Ingenuity was required because the tried and true methods that suffice for the large majority of ADA assessments could not attain the level of sensitivity demanded in this case. It required BioAgilytix to flex its knowledge and the techniques used for other applications in new and innovative ways.
The following areas of expertise were vital to BioAgilytix’s overall solution:
Combining research drive and development discipline, BioAgilytix developed a method that leveraged existing technologies in unique ways and ultimately arrived at a regulatory compliant and defendable approach for the client.
By bringing a novel method from proof of concept to an actual practical solution, BioAgilytix helped the sponsor company meet drug tolerance requirements while maintaining high sensitivity. The method is proving out and providing important data in the project’s clinical development phase.
Through its unique solution, BioAgilytix was able to meet regulatory expectations and provide important safety information that, coupled with efficacy data, will likely lead to a new therapeutic drug to address an unmet medical need.
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.