Our European Headquarters

Delivering the Premier Bioanalytical Services Europe Needs for Small and Large Molecule Studies

BioAgilytix’s advanced laboratory facilities in Hamburg, Germany, serve as our European headquarters, offering a breadth and depth of services, technology, and expertise specifically for small and large molecule bioanalysis.

We are focused on delivering premium science to support global studies in biotherapeutics development involving immunogenicity, pharmacokinetics (PK), biomarkers, and cell-based assays. Learn how we are helping leading pharmaceutical and biotechnology companies effectively navigate the evolving opportunities in small and large molecule drug development with best-in-class bioanalytical testing methods.

Deep Experience to Drive New Innovation

Science-Driven Services for Every Phase

State-of-the-Art GLP Facility & Platforms

Partners in Biotherapeutics Advancement

Fully Integrated Bioanalytical Services For Every Phase

From discovery to Phase I, II, III, and IV trials, our European lab operates under GLP guidelines and provides fully integrated services to move your project through the development pipeline efficiently and with the highest quality science. Our capabilities include assay development, assay validation, sample analysis, and lot release testing for biologic products targeting a range of disease states, and support for solutions that harness the power of gene therapy, immuno-oncology, biosimilars, and other evolving biologic innovations. Our European team possesses the extensive scientific experience that enables us to customize our assays to the needs of our customers to ensure the required level of specificity, precision, turnaround time, regulatory compliance, and more.

Our ability to handle all phases of large molecule studies means that you can rely on a single bioanalytical lab partner to efficiently progress your innovation, without time-consuming handoffs, gaps in knowledge, and other issues that could threaten development timelines when transferring projects between labs. You’ll have a science-driven collaborator for all bioanalysis related to:

Biomarkers

Immunogenicity

PK/PD

Cell-Based Assays

Biosimilars testing

Biomarkers

Our biomarker services support global studies for a range of disease states, from oncology to autoimmune, neurological, and metabolic disorders. Our Hamburg lab is able to leverage the extensive menu of over 400 biomarkers that we have developed to help streamline biotherapeutics development timelines, or can collaborate to develop and validate novel biomarker assays.

Immunogenicity

BioAgilytix’s USA lab performs immunogenicity testing to evaluate a biological product candidate’s incidence, kinetics and magnitude of anti-drug antibody (ADA), neutralizing ability, cross-reactivity with endogenous molecules or other marketed biologic drugs, and the related clinical impact for patient management. Our USA team is well-versed in the complexities inherent in measuring adverse immune reactions, and works closely with our customers to develop the optimal assay strategy for their specific immunogenicity testing requirements.

Pharmacokinetics (PK)

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.

Cell-Based Assays

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.

Biosimilars Testing

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.

Advanced Glp Lab Equipped With State-Of-The-Art Technology

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:

MSD-ECL

ImmunoCAP

ELISA

GYROLAB xPand

Flow Cytometry
(FACS Analysis)

Biacore T200

ELISpot

RoboSep-S

Veteran Small And Large Molecule Expertise To Drive New Biologic Testing Innovation

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.

ON-DEMAND WEBINAR

Recent Aspects and Challenges in the Assessment of Immunogenicity

Dr. Arno Kromminga discusses the emerging technologies that are making analytical and clinical data interpretation of immunogenicity more challenging, and the issues that must be addressed in the comparative immunogenicity analysis of an innovative therapeutic and biosimilar.

Partners In Your Success, In Support Of Your Patients

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.

To learn more about BioAgilytix’s European headquarters and the services we provide, please contact:

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

Our Laboratories

European HQ

Lademannbogen 10
22339 Hamburg Germany
+49 40 526779 0

~ 100 employees
3,222 square meters

Durham Corporate HQ

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.

2300 Englert Dr
Durham, NC, 27713
919-381-6097
Fax 919-381-6099

~ 470 employees
89,109 total sq. ft.
Upcoming addition of second campus to bring total sq. ft. to ~265,0000

Boston Laboratory

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.

1320 Soldiers Field Road
Boston, MA, 02135
617-456-0700
Fax 617-456-0700

~ 90 employees
22,205 total sq. ft.

San Diego Laboratory

With advanced laboratories facilities in Durham, Boston, San Diego, Hamburg, Germany, and Brisbane and Melbourne, Australia we can support all global studies.

9050 Camino Santa Fe
San Diego, CA 92121
858-652-4600
Fax 617-456-0700

~ 90 employees
22,205 total sq. ft.

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USA HQ

2300 Englert Dr

Durham, NC, 27713

919-381-6097

Fax 919-381-6099

San Diego Laboratory

9050 Camino Santa Fe

San Diego, CA 92121

858-652-4600

Fax 858-652-4699

Brisbane Laboratory

37 Kent St, Woolloongabba

Queensland, 4102, Australia

USA HQ

2300 Englert Dr

Durham, NC, 27713

919-381-6097

Fax 919-381-6099

San Diego Laboratory

9050 Camino Santa Fe

San Diego, CA 92121

858-652-4600

Fax 858-652-4699

Brisbane Laboratory

37 Kent St,Woolloongabba

Queensland, 4102, Australia

Boston Laboratory

1320 Soldiers Field Road

Boston, MA, 02135

617-456-0700

Fax 617-456-0701

Boston Laboratory

1320 Soldiers Field Road

Boston, MA, 02135

617-456-0700

Fax 617-456-0701

European HQ

Lademannbogen 10

22339 Hamburg Germany

+49 405267790

Melbourne Laboratory

85 Commercial Road, Melbourne

Victoria, 3004, Australia

+61 3 9282 2184

European HQ

Lademannbogen 10

22339 Hamburg Germany

+49 405267790

Melbourne Laboratory

85 Commercial Road, Melbourne

Victoria, 3004, Australia

+61 3 9282 2184

Durham Lab (USA HQ)

2300 Englert Dr
Durham, NC, 27713
919-381-6097
Fax 919-381-6099

Morrisville Lab

5927 S. Miami Blvd. Suite 100
Morrisville, NC 27560
919-381-6097
Fax 919-381-6099

Boston Lab

1320 Soldiers Field Road

Boston, MA, 02135

Office 617-456-0700

Fax 617-456-0701

San Diego Lab

9050 Camino Santa Fe

San Diego, CA 92121

858-652-4600

Fax 858-652-4699

Hamburg Lab (EU HQ)

Lademannbogen 10

22339 Hamburg Germany

+49 405267790

Brisbane Lab

37 Kent St, Woolloongabba

Queensland, 4102, Australia

Melbourne Lab

85 Commercial Road, Melbourne

Victoria, 3004, Australia

03 9282 2184

Durham Lab (USA HQ)

2300 Englert Dr
Durham, NC, 27713
919-381-6097
Fax 919-381-6099

Morrisville Lab

5927 S. Miami Blvd. Suite 100
Morrisville, NC 27703
919-381-6097
Fax 919-381-6099

Boston Lab

1320 Soldiers Field Road

Boston, MA, 02135

617-456-0700

Fax 617-456-0701

San Diego Lab

9050 Camino Santa Fe

San Diego, CA 92121

858-652-4600

Fax 858-652-4699

European HQ

Lademannbogen 10

22339 Hamburg Germany

+49 405267790

Brisbane Lab

37 Kent St,Woolloongabba

Queensland, 4102, Australia

Melbourne Lab

85 Commercial Road, Melbourne

Victoria, 3004, Australia

03 9282 2184

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