Process Development

Cytovance Biologics Cytovance® Biologics provides extensive mammalian and microbial pharmaceutical R&D service offerings that are both stand-alone and cGMP-enabling. Services include cell line development using Freedom® CHO-S® (Life Technologies), microbial strain development using GeneGPS Codon Optimization Technology (DNA2.0) and Cytovance® Biologics' Keystone Expression System™, research cell bank production, process development, process optimization using statistical Design-of-Experiments (DoE), technology transfer, scaled-down model development and process characterization using a QbD framework.

Each customer project is customized to match the required scope and clinical phase. Commercial and in-house mammalian and microbial platform processes enable efficient movement through development programs and into commercialization.

A strong Analytical Development team is integrated into R&D services. Core competences include method development, method transfer, method optimization and robustness testing, pre-qualification, QC method transfer, preformulation development, and product characterization. Cytovance's newest offering are a Manufacturability Assessment for mAbs and Expression Feasibility for E. coli-derived proteins, which are focused on early phase customer needs.