Stable Cell Line Generation, Optimization and Downstream Processing
Preclinical development of biotherapeutics relies on the production, purification, and formulation of high-quality therapeutic proteins in sufficient quantities to support preclinical testing and further development. This is accomplished through the development and optimization of stable cell lines for protein production and the establishment of downstream processing for purifying and formulating your biologic. Together, these steps ensure the biotherapeutic meets regulatory standards and can be produced in a scalable, cost-effective manner.
Access a Reliable and Scalable Source of Therapeutic Protein
At Eurofins Discovery, we can generate and optimize stable cell lines for producing a broad range of biotherapeutics, perform small-scale biologics expression, and develop a downstream processing approach. Our scientific experts can ensure that you can express and purify the most promising lead biologics to confidently complete preclinical development.
Stable Cell Line Optimization
Stable cell line optimization involves the engineering of cells that can consistently produce the necessary amounts of a high quality lead biotherapeutic protein. Documented single-cell cloning and a reliable scalable source of high-quality therapeutic protein is essential for animal studies and preclinical testing, enabling accurate assessments of MoA, efficacy, and safety. Our cell line development experts can help streamline your manufacturing processes, reduce development time and costs, and ensure compliance with biomanufacturing standards.
Downstream Processing for Therapeutic Antibody Production
The goal of downstream processing, which involves purifying and formulating a therapeutic antibody lead, is to provide high-purity, stable, uniform and safe antibodies for conducting preclinical studies. Reducing the risk of safety issues in preclinical studies and ensuring the early establishment of an efficient, scalable process helps to overcome biomanufacturing hurdles and reduces the time and cost of biologics production.
