BioAgilytix’s advanced laboratory in Hamburg, Germany serves as our European headquarters, offering a breadth and depth of services, technology, and expertise specifically for 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 large molecule drug development with best-in-class bioanalytical testing methods.
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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:
Our Hamburg team has particular strength immunogenicity, with our European CSO Dr. Arno Kromminga 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.
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 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.
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.
Our 1,765 sq. meter Hamburg lab facility 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’ 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 by Dr. Arno Kromminga, our European CSO, 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 large molecule project they touch, applying the insights learned through these firsthand experiences to continue to drive new 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 in support of our customers and the patients they serve.
We are committed to continually improving our own science, staying on top of the latest innovations in bioanalytical testing and technology, to help our customers continue to improve the lives of patients with acute, chronic, and rare diseases. We take a collaborative approach to solving the complex challenges inherent in large molecule bioanalysis, and 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 the patients that need new biotherapeutic breakthroughs the most.
To learn more about our European lab and the services we provide, please contact the following members of our leadership team:
PD Dr. Arno Kromminga
SVP and European CSO
+49 (0) 40 – 526779 – 2
Dr. Nina Nehmann
Head of Quality Assurance
+49 (0) 40 – 526779 – 11
Lademannbogen 10 22339, Hamburg, Germany