On this episode of Molecular Moments, Chad Briscoe speaks with Dr. David Berkowitz, Director of the Division of Chemistry at
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
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.