Bioassays as a Service | ProBioGen AG

We offer you bioassays at all levels, with flexible start and end points. Regardless of whether you already have a suitable bioassay, we can take over your protocol and either optimize it or develop an assay from scratch (even as a stand-alone service). Choose from different bioassay maturation levels, from robust lab methods to early characterization or comparability studies to fully validated assays for GMP-batch release testing (up to finished medicinal product).

Overview

Experience in Biopharmaceuticals

Broad Bioassay Portfolio

Integrated Bioassay Services

Fully Compliant

In terms of scientific, technological, and statistical approaches, we follow best practices to develop, validate, and control the bioassays in order to support your biologics in clinical phase studies and market supply. Our bioassays comply with the regulatory requirements and standards of FDA/EMA and comply with the guidelines issued by ICH.

In Experienced Teams

Our dedicated and experienced (> 20 years) bioassay unit delivers prompt and reliable potency data at each project phase, whether it is an early development phase or GMP batch release and stability testing, in order to track and maintain the potency of your biologic throughout the project. We master the challenges in terms of special assay features and time components.

Broad Range

We have a broad range of binding and functional bioassays, as more complex molecules require supplementary potency data. We are highly experienced in multiple assay types and have access to several target cell lines, reporter cell lines, and primary cells so that we can easily adapt basic protocols to your biologic's needs. This wide spectrum also makes us an ideal partner for biosimilarity assessments.

Deep Understanding for Molecules

As complex as necessary, as simple and robust as possible. We promote a deep understanding of the critical steps and components of our bioassays to ensure a seamless transition from the development to the validation phase as well as stable performance going forward. This approach also allows for a smooth transfer to second parties, even those with less experience.

Our analytical expertise assures adequate bioactivity data at all stages, from cell line development (CLD), process development (USP/DSP) and manufacturing to release.