(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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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 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 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 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 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, working with an array of both emerging and large pharmabio customers, provides robust, compliant bioanalytical assessments for the diverse range of vaccine varieties in development today. With leading expertise in complex biologics and a broad suite of advanced platforms, we can apply the optimal, phase-appropriate method to meet your unique vaccine program needs.
Vaccine development is one of the most diverse and fastest growing areas in pharmaceuticals and biotechnology. The serious impacts of infectious diseases like Ebola, malaria, HIV, and COVID-19 on world health have continued to make vaccines a focus of substantial social consideration, and new generations are being explored to find cures for diseases with no effective treatments yet available.
BioAgilytix’s deep experience in cell-based assays, immunology, and potency assay development for biologics enables us to effectively collaborate with sponsors on complex bioanalytical assessments for diverse vaccine varieties. Generation 1 vaccines, which are infectious agent-based, still hold a significant position in disease prevention. Our expertise in developing a range of immune-based methods on a broad set of platforms allows us to efficiently develop these assays under GMP regulatory expectations.
The development of Generation 2 and 3 vaccines, which can include recombinant proteins and virus-like particles (VLPs), nucleic acid- or vector-based vaccines, and emerging virus neutralization approaches such as monoclonal antibodies directed at the target virus, have grown significantly owing to their relative control, reduced risk, and targeted effectiveness. These products are often initially developed using animal models and determination of immune response. Industry focus to address the ‘3Rs‘ – replace, reduce, refine – to minimize the use of animal testing has driven their transition to in vitro potency assays which are often met using immune-based methods. In some instances, this method is complemented with an in vivo assay or a cell-based assay. Cell-based assays for these vaccines are typically required to demonstrate mode of action (i.e. particle or protein interaction with a target cell).
We summarize key insights from our recent study to translate diagnostic virus neutralization method to a quantitative cell-based assay for the determination of relative potency of an anti-influenza antibody.
The science behind vaccines has advanced substantially in recent years – as have regulatory expectations. Potency assays have evolved from simple titers to relative potency determinations to demonstrate appropriate control of the product. The 3Rs initiative is also driving more vaccine testing to move from in vivo animal models to in vitro using epitope-targeted ELISAs or cell-based assays with immune-pertinent systems.
BioAgilytix’s expertise in developing a range of ELISA and cell-based assays for biologics and gene & cell therapies on a broad set of platforms, paired with our specialization in immunology and with ADA and NAb assays, ensures your vaccine products are well-positioned to successfully advance down the development and approval pathways.
Our experience is deep across the range of assays below performed under GxP regulations:
Through these comprehensive assessments we are able to help ensure your vaccine products are well-positioned to successfully advance down the development and approval pathways.
BioAgilytix’s GMP staff has more than 100 years of collective experience in developing immune-based methods and cell-based assays to measure potency, which we leverage in testing for a myriad of vaccine types. We validate assays to ICH standards and apply phase-appropriate criteria to support your vaccine program lifecycle from early phase development through pre-commercial/Phase III efforts. We’ll work closely to define your specific assay requirements and facilitate selection of the best platform for everything from short-term feasibility studies to long-term robust product release testing.
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
