European Headquarters
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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.

biotechnologie hamburg

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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 small and 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:





Pharmacokinetics (PK)






Cell-Based Assays



Biosimilars Testing



Our Hamburg team has particular strength immunogenicity, with our Chief Scientific Advisor having led their involvement in some of the earliest cases of immunogenicity testing. We understand the many drug- and disease-specific aspects that impact immune response measurement, and work closely with sponsors to select the appropriate assays and assay strategy specifically for each project. We take a tiered approach to testing that leverages anti-drug antibody (ADA) analysis, ADA characterization, and neutralizing antibody (NAb) analysis.

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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.

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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.

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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.

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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.

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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:

elisa platform analytical device


msd-ecl platform analytical device


flow cytometry platform analytical device

Flow Cytometry
(FACS Analysis)


biacore t2000 platform analytical device

Biacore T200

immunocap platform analytical device


ELISPOT platform analytical device



gyrolab xpand





bioanalytical services belgium & biotechnologie hamburg

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.


immunogenicity 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.

Watch Webinar Now


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]

Directions to our European headquarters

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

Schedule a Meeting with Our European Team