Process Development Services for Proteins & Antibodies

Based on our years of experience, we initiate process development at an early stage in order to set the course for successful development and identify potential. Therefor we rely on material production from pools to perform the initial parameter screening. This is done in close collaboration with you in order to define process expectations.

Our integrated approach to cell line and process development minimizes unwanted variants from the start and maximizes production yield. Through inter-departmental collaboration, we optimize key process conditions to establish a robust, scalable process for consistent large-scale manufacturing.

Collaborative & Integrated Approach

A cross-departmental project team ensures interdisciplinary collaboration between cell line development (CLD), upstream and downstream process development (USP/DSP) and quality control (QC) from the earliest stages of each project. Additionally, the analytical groups in CLD, USP, DSP, and QC work closely together in method development, method transfer, and the establishment of product-specific standards. The integrated structure of the USP and DSP teams ensures seamless collaboration between development scientists and production engineers, ensuring a robust and reliable process transfer, from development to full-scale production.

Robust and Economic Platform Processes

Our robust and scalable USP platform process forms the foundation of every process development project. This platform supports either rapid and efficient development (e. g., fast track) or provides a solid base for more comprehensive process optimization. Our DSP platform processes and the analytical framework create an opportunity for efficient but flexible developments - the suitability of the DSP platform will be assessed as part of the early process development. The integrated formulation development ensures maximum understanding of your product behaviour and therefor helps to optimize your downstream process. This synchronized approach ensures a seamless workflow and is crucial for the successful production of the drug substance, thus paving the way for your product's success.

State-of-the-Art Technologies

Successful process development is ensured through our state-of-the-art facilities and innovative process design strategies. Whether you need a standard fed-batch process or an intensified approach, our diverse range of systems ensures consistent performance across various production scales. We continuously optimize our processes by leveraging the latest advancements in technology and methodology. High-throughput and automated methods, along with complex design of experiments (DoE), ensure the highest levels of consistency and quality throughout process development.

Modular Service Concept

Our modular service concept provides maximum flexibility and can be tailored to your product's specific needs. Whether you require early process development, fast-track modules or advanced development for bi-/multi-specific antibodies, our services can be booked as a complete package or in individual steps.

Additionally, we offer a range of supplementary services, including USP intensification, formulation studies, and integrated virus clearance studies with at least two orthogonal steps, starting from Phase I production.