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CDMO SERVICES FOR QUALITY & ANALYTICS

Bioassays

Don't you deserve the most reliable, precise bioassays — tailored to your biopharmaceutical? 

Our cutting-edge expertise, combined with innovative assay design, ensures your product's potency and stability are tested at the highest standards. Our designs ensure seamless regulatory approval and efficient clinical development.

IN A NUTSHELL

Bioassay Development for Biopharmaceuticals

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). 

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OUR CAPABILITIES

What You Get

Overview

Experience in Biopharmaceuticals

Broad Bioassay Portfolio

Integrated Bioassay Services

HOW WE WORK

Holistic Approach

 

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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HOW WE WORK

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. 

 

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Our Promise To You

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Best-in-Class Bioassay Development 
  • Fast assay development, even from scratch  
  • Optimization of existing client assay or product-specific adaptation of platform assay possible thanks to our diverse assay experience and broad assay portfolio 

 

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Process Integration
  • Full process integration to facilitate a deep understanding of the bioactivity throughout the different project phases and help determine key parameters

 

 

 

Success
 
High Quality  
  • Constant delivery of adequate bioactivity data 
  • Top-grade assay qualification and validation  
  • Well-trained operators who ensure excellent assay quality, even for long-term stability studies  

 

Our Promise to You

Rely on Fast Timelines

  • One-Stop-Shop with seamless, integrated Services
  • Parallel Processes
  • Efficient project execution
  • Do it right from the beginning

Get Your High Quality Candidate

  • Scientific excellence
  • Deep understanding for molecule / Long + broad experience
  • Strong Analytics teams and stellar quality management services
  • Enabling technologies

Have the Flexibility You Need

  • Modular Offering
  • Customer Centricity/ Strong Partnership Approach
  • Experienced Project Managers and efficient decision-making

Elevate Your Candidate With The Right CDMO

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