(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 
This is the final blog in our three-part flow cytometry series. Part 1 highlighted the broad application of flow cytometry
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 
PCR platforms and Good Manufacturing Practices (GMP) certification further enhance European service offerings HAMBURG, GERMANY and DURHAM, NC, May 8,
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BioAgilytix continues to build leadership in Europe. Hamburg, Germany April 3, 2023 – BioAgilytix, a leading global bioanalytical laboratory, today
Share This This is the final blog in our three-part flow cytometry series. Part 1 highlighted the broad application of flow cytometry
Share This 
As we continue our blog series on flow cytometry, we’ll now dive into how this powerful capability supports multiple types
Share This 
Analytical testing of therapeutic compounds often requires data at the single-cell level. Flow cytometry is a versatile technology that can
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 This is the final blog in our three-part flow cytometry series. Part 1 highlighted the broad application of flow cytometry
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 PCR platforms and Good Manufacturing Practices (GMP) certification further enhance European service offerings HAMBURG, GERMANY and DURHAM, NC, May 8,
Share This BioAgilytix continues to build leadership in Europe. Hamburg, Germany April 3, 2023 – BioAgilytix, a leading global bioanalytical laboratory, today
Share This This is the final blog in our three-part flow cytometry series. Part 1 highlighted the broad application of flow cytometry
Share This As we continue our blog series on flow cytometry, we’ll now dive into how this powerful capability supports multiple types
Share This Analytical testing of therapeutic compounds often requires data at the single-cell level. Flow cytometry is a versatile technology that can
Share This
A Biopharmaceutical Company developed a novel drug delivery platform which increased the absorption and distribution of co-administered biological compounds. The concentration of the biologic could be measured directly in the serum; whereas the efficacy of the biologic and its delivery could be inferred by either the pharmacokinetic profile of the drug being delivered with the biologic, or by measuring the release of a key biomarker directly related to the activity of the biologic.
Two methods of analysis were being utilized to measure the concentration of the key biomarker during clinical studies; however, detection was complicated because the biomarker varied in structure and size. The ELISA based method did not recognize all forms of the biomarker and potentially underestimated the total concentration of the biomarker. The HPLC-fluorescence method required lengthy enzymatic digestion, followed by a derivatization step and subsequent chemical reduction to stabilize the derivative. These procedures were followed by a 45 minute gradient elution which was required to resolve the peak from endogenous interferences with similar digestion products. Additionally, the HPLC-fluorescence method was not sensitive enough to detect endogenous levels of the biomarker.
Our scientists employed a faceted approach to resolve the analytical shortcomings of the two existing methods by developing an LC/MS/MS method.
We carefully optimized the enzymatic digestion step to ensure complete digestion of all forms of the biomarker to a common fragment. We then evaluated several potential MS-compatible derivatives of that molecule, identifying a derivatization reagent with several advantages over the previous fluorescent tag. The derivative chosen was stable, did not require a reduction step, and allowed for sensitive and selective detection in MRM mode. The new derivatization procedure was not affected by moisture, which allowed the digestion to be followed by a simple protein precipitation technique prior to derivatization.
The tag facilitated detection in negative ion mode. This served to mediate the effects of adduct formation, which most of the positive ion-mode tags suffered from. The tag also increased hydrophobicity, allowing a wider range of chromatographic options. Most importantly, a deuterium-labeled form of the tagging reagent was available. This enabled us to create an ideal internal standard by reacting the digested fragment with stable labeled reagent.
All of the facets worked in concert to achieve the accuracy and precision needed for a successful, GLP-compliant validation. During validation, several forms of the biomarker – spanning the range of sizes expected in subjects – were used to make QC samples which were tested with the method. The overall sensitivity of the LC/MS/MS assay allowed determination of basal endogenous levels and the method provided accurate and precise concentration data for all forms of the biomarker evaluated.
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.
