Analytics & Bioassays for Proteins and Antibodies

Our interlocked analytical teams accompany the maturation of your product at any development stage. We provide a fit-for-purpose analytical tool kit, from cell line development to process batch release testing and stability studies supported by a strong microbiological unit and a dedicated bioassay team. Our experience in mammalian cell culture and analytics of glycoproteins assure the quality and safety of your drug candidate. With our expertise in new biologic formats beyond traditional antibodies, you can accelerate your development process, thereby reducing time to market.

Analytics in Cell Line Development

Analytics in Process Development

QC Testing

Bioassays

Experience & Expertise

More on experience / scientific approach and expertise

Integrated Workflows & Integrated Analytical Team

This approach is further advanced through a fully integrated analytics team and close inter department collaboration with the manufacturing groups, as well as deep interaction with our client’s experts.

Do Right from the Beginning with the CHO.RiGHT Platform

With no royalties or license attached our first class cell line development service for biologics is based on our CHO.RiGHT platform. It combines our cutting-edge DirectedLuck transposase and transposons with our highly optimized CHO host cells and our own chemically defined process media. We use our unique, fast-growing CHO-DG44 strain, which is characterized by high genetic stability and a highly efficient metabolism. For molecules where the formation of distinctive product features is required, we can also use a wide range of pre-engineered hosts or other strains.

Access to the Right Technologies

In addition to the platform, it is also very important to have access to the right technologies, such as our GlymaxX technology to produce afucosylated or partially fucosylated antibodies.

Automated Processes

Intelligent automation steps do not only streamline the entire process but help to identify better clones. All this goes hand in hand with scientific excellence, strong problem solving skills, flexibility and resources to tackle unforeseen challenges, and de-risking strategies.

Starting with Multiple Candidates

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Fully Compliant

In terms of scientific, technological and statistical approaches, we follow best pratice to develop, validate and control the bioassays to support your biologics in clinical phase studies. Our bioassays comply with the regulatory requirements and standards of US Food & Drug Administration (FDA) and European Medical Agency (EMA) and follows the guidelines issued by International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).

Experienced Teams

Our specially destined, interactive and well experienced (> 20 years) bioassay unit (analysts and scientists) delivers prompt and reliable potency data at each project phase, wether it´s an early development phase or GMP batch release and stability testing 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 of xyz

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. Based on this wide spectrum we are also an ideal partner for biosimilarity assessments.

Deep Understanding for Molecules

As complex as necessary, as simple and robust as possible: we promote deeply understanding of the critical steps and components of our bioassays for seamless transition from development into validation phase and stable performance over years. This approach also allows for smooth transfer to second parties even with less experience.

Our analytical expertise assures proper bioactivity data at all stages from CLD, PD (USP/DSP) and manufacturing up to release: