(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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Entering the biosimilars market is an enticing prospect for many biopharma companies, offering the potential for reduced development and manufacturing
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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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Promising broader patient access to critical medicines, biosimilars offer a more cost-effective alternative therapeutic option compared with originator products. With
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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,
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Durham, NC, August 17, 2022 – BioAgilytix Labs, LLC (BioAgilytix), a leading contract research organization supporting pharmaceutical and biotech partners in
Share This 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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As therapeutic drugs have grown in complexity, so too have the bioanalysis techniques to support these products. Bioanalysis of small molecule
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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 Entering the biosimilars market is an enticing prospect for many biopharma companies, offering the potential for reduced development and manufacturing
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 Promising broader patient access to critical medicines, biosimilars offer a more cost-effective alternative therapeutic option compared with originator products. With
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 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 As therapeutic drugs have grown in complexity, so too have the bioanalysis techniques to support these products. Bioanalysis of small molecule
Share This
BioAgilytix performs compartmental (model-dependent) or noncompartmental (model-independent) pharmacokinetic analysis, using validated Phoenix WinNonlin software. We produce pharmacokinetic and toxicokinetic reports to support discovery, preclinical, GLP toxicology, and clinical studies. We conduct PK simulations to predict the plasma concentration profile of a drug under various input conditions.
We also offer pharmacokinetic consulting, which includes assistance with PK study design, protocol development, and performing PK calculations for our clients.
BioAgilytix specializes in conducting pharmacokinetic (PK) data analysis for discovery, preclinical, and clinical studies. We perform both compartmental (model-dependent) and noncompartmental (model-independent) analyses, using validated Phoenix WinNonlin software. We rapidly assess bioequivalence, drug exposure, DDI (drug-drug interactions), food effects on pharmacokinetics, and drug recovery data. We will also provide assessments of PK/PD relationships.
For GLP toxicology studies, we perform noncompartmental analysis to establish exposure, accumulation, linearity of PK parameters, differences in sex-related exposure, and a comparison of dose-related exposure.
We can use existing PK data to predict the plasma concentration profile of a drug under various input conditions. This information allows you to preview the potential effect of various routes of administration, multiple dosing regimens, and variable infusion schedules and can provide valuable insight into the design of preclinical and clinical studies.
Our scientists have decades of drug discovery and development experience and will provide you with the advice and support necessary to help advance your pharmacokinetics programs. BioAgilytix can help design appropriate studies for pharmacokinetic analysis, perform pharmacokinetic calculations, and incorporate bioanalytical data into regulatory submissions.
BioAgilytix uses the latest version of Phoenix WinNonlin to perform PK and TK calculations, in addition to creating SEND data transfer files.
Learn how customizing specimen collection kits for specific clinical trial sampling requirements streamlined our client’s Phase I study and helped ensure that all specimens collected were stabilized, properly labeled, and provided accurate pharmacokinetic data.
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.
