(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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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 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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(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 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 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
Our European team understands the importance of PK assay data to sponsors, as it is vital to determining dosage selection for preclinical and clinical studies. They are well-versed in the factors that could influence assay data validity, and account for these realities during method validation to ensure optimal results. Our Hamburg lab has particular expertise in establishing and validating PK assays for therapeutic proteins with endogenous counterparts, and for comparative analysis of originator and biosimilar products.
Our European team develops and validates cell-based assays to evaluate a variety of functional and biochemical effects, including cell proliferation, apoptosis and cell death, signal transduction, enzyme activity, reporter gene activity, antibody-dependent cell-mediated cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC), and more.
The biosimilar expertise within our Hamburg lab team runs deep. These scientists supported the first biosimilar erythropoietin (EPO) launch in Europe, as well as the first biosimilar EPO filed in the USA. As pioneers in this exciting area of biotherapeutics development, they bring an unmatched level of experience and insight on how to best overcome the complexities inherent in demonstrating biosimilarilty between a biological product and its reference product.
BioAgilytix’s 1,765-square-meter lab facility in Hamburg is one of the most technologically advanced bioanalytical laboratories in Europe supporting biotherapeutics development, and boasts world-class resources to help us efficiently and effectively advance our customers’ small and large molecule projects. We conform to all GLP requirements (click to view our GLP statement), making this lab an ideal location for European sponsors to support preclinical studies under GLP. All work can remain in the EU to avoid costly sample shipment issues such as CITES, import and export permits, etc.
Our Hamburg laboratory is equipped with an array of industry-leading bioanalytical platforms, which we use to support global studies:
Our European lab was founded as IPM Biotech in 1996. For the research of chronic inflammatory diseases. Since then the Hamburg team has been involved in some of the very first cases if immunogenicity, supported the first biosimilar EPO launch in Europe, and contributed to the first biosimilar EPO filed in the USA. They bring this unequaled level of expertise to every new small and large molecule project they touch, applying the insights learned through these firsthand experiences to continue to drive new small and large molecule testing innovation for our customers today.
This lab was founded to change the field of medical diagnostics by generating specialized assays in order to perform not only routine diagnostics, but also to diagnose rare diseases. We carry on that mission today, serving pharma and biotech sponsors in Hamburg, Europe, and around the world who are developing the next generation of life-savings drugs.
While our reach extends globally to support studies wherever they are taking place, you’ll have local access to our expert team in Hamburg at any time. We can easily deliver highly collaborative bioanalytical services with face-to-face interactions to sponsors in Germany, Switzerland, Scandinavia, Belgium, France, UK, Itay, Spain, and throughout Europe. We welcome you to visit our Hamburg lab facility to meet the scientists you’ll be working with and learn more about our capacity to support projects end to end – from assay development and validation to sample analysis.
We strive to work as a seamless extension of your internal team so that we can add the value of specialized insight where needed. Together, we will achieve more for patients that need new biotherapeutic breakthroughs.
BioAgilytix – European Headquarters
+49 40 526779 0
[email protected]
Lademannbogen 10, 22339 Hamburg, Germany
Managing directors: James A. Datin, Dr. Frank Horling
Registered: BioAgilytix Europe GmbH, AG Hamburg, HRB 105 172; St. Nr 50/734/00432 VAT-ID: DE 259000948
This is BioAgilytix’s largest, most advanced laboratory, located in the Research Triangle Area of North Carolina. This location also serves as our Corporate Headquarters, where we combine specialized expertise, state-of-the-art technology, and deep regulatory knowledge to provide premier biologics services that accelerate global clinical studies through every stage of development.
BioAgilytix’s Boston laboratory is located in the heart of the world’s biotech innovation hub and boasts a 20-plus-year track record of delivering premier bioanalytical services along with specialized diagnostic testing.
With advanced laboratories facilities in Durham, Boston, San Diego, Hamburg, Germany, and Brisbane and Melbourne, Australia we can support all global studies.
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.
