(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, Chad Briscoe speaks with Dr. David Berkowitz, Director of the Division of Chemistry at
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Analytical testing of therapeutic compounds often requires data at the single-cell level. Flow cytometry is a versatile technology that can
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In this article, Chief Scientific Officer at BioAgilytix, Jim McNally, Ph.D., explores why bioanalysts should prepare for the impending wave
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Once the patent on a previously ground-breaking blockbuster molecule comes to an end, there is an opportunity for biosimilar versions
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BioAgilytix adds New VP of Business Development in Europe Hamburg, Germany 01 March 2023 – BioAgilytix, a leading global bioanalytical
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78,000 Square Feet of Lab and Office Space Added in the First of a Multi-Phase Expansion Durham, NC, October 19,
Share This Analytical testing of therapeutic compounds often requires data at the single-cell level. Flow cytometry is a versatile technology that can
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Entering the biosimilars market is an enticing prospect for many biopharma companies, offering the potential for reduced development and manufacturing
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3 key challenges facing the biosimilars space in 2023 In 2010, the biopharma industry saw an abrupt patent cliff: a
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(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, Chad Briscoe speaks with Dr. David Berkowitz, Director of the Division of Chemistry at
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 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 BioAgilytix adds New VP of Business Development in Europe Hamburg, Germany 01 March 2023 – BioAgilytix, a leading global bioanalytical
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 Analytical testing of therapeutic compounds often requires data at the single-cell level. Flow cytometry is a versatile technology that can
Share This Entering the biosimilars market is an enticing prospect for many biopharma companies, offering the potential for reduced development and manufacturing
Share This 3 key challenges facing the biosimilars space in 2023 In 2010, the biopharma industry saw an abrupt patent cliff: a
Share This
Unbound circulating drugs have the best access to targets and excretion pathways; therefore, the binding of drug candidates to plasma proteins plays a significant role in efficacy, drug distribution, and establishing safety margins. For these reasons, pharmaceutical companies and regulatory agencies are interested in determining the extent of drug binding to plasma and/or tissue proteins early in the drug development process.
Our scientists measure the binding of test articles to plasma or tissue proteins using the following sequence:
BioAgilytix employs the following methods to determine unbound drug concentration in plasma, serum, or tissue:
The plasma or tissue sample is first spiked with the test article at one or more concentrations and then incubated with the appropriate matrix for a prescribed period of time; however, samples from clinical or toxicology studies can be used instead. The unbound concentration is then determined using one of the above mentioned assays, followed by LC/MS analysis. Equilibrium dialysis can be performed with the RED device or a Spectrum 20. Several concentrations can be used to calculate a dissociation constant, Kd.
We routinely measure and compare protein binding in plasma or serum from the following species:
Protein binding can also be assessed for individual proteins, such as:
Depending on your study needs, we will perform:
A pilot study is conducted to determine which methodology (equilibrium dialysis, ultrafiltration, or ultracentrifugation) is most appropriate for the measurement of the unbound test article. During this study, we will assess stability in plasma at 37ºC, non-specific binding to the apparatus, and the estimated protein binding ratio. The results from these assessments will allow us to select the method best suited to provide robust results for the test article.
During the pilot study, we may find it necessary to stabilize the compound with protease inhibitors, or to determine non-specific drug-protein binding for each concentration, so we can normalize the binding ratio. Our extensive experience with protein binding studies enables us to handle compounds with limitations of stability and/or solubility.
The compounds are spiked into plasma or serum and dialyzed overnight using the RED device. Following the incubation, the recovery samples, donor sides, and receiver sides are analyzed by time-of-flight mass spectrometry, using a generic method. We then calculate the binding values and percent recovery from the relative peak heights.
When compounds with low recovery are encountered, we notify the sponsor and give them the option of investigating non-specific binding and stability in plasma.
BioAgilytix is one of the largest bioanalytical LC/MS laboratories on the West Coast of the United States. The instrumentation at our facilities is state-of-the-art and constantly upgrades equipment to remain at the forefront of the industry.
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 27703
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.
