Suspension Cell Culture

Esco Aster provides CDMO services to cell culture process develop and manufacture production cell lines used for early-stage research to preclinical and clinical phase trial. Our cell culture process development services support clients' specific requirements for cell culture process development and optimization regardless of its current development status, whether the product is in early-stage development or ready to launch, as well as media and feed screening and process parameter optimization.

Our capabilities include process development services from upstream to downstream bioprocessing, analytical testing via process analytical technology (PAT) as well as chemistry, manufacturing, and controls (CMC) regulatory approval of your products.

Esco Aster offers clients the media screening and feed optimization using a Design-of-Experiment (DOE) approach in the scale-down model. The study design consisted of the desired experimental conditions combines the animal component-free chemically defined (ACFCD) cell culture media with main feed and feed supplements, along with feed volumes and frequency of addition optimized to maximize product productivity over a time course.

Individual experimental conditions are evaluated and spent media are analyzed statistically, with the best conditions chosen for further development.

Esco Aster can develop the cell culture operation in our proprietary bioreactors (BioXcell^®) with a deep understanding of the process and a state-of-the-art cell culture development facility. Through the investigation of interactions between parameters such as temperature, pH, gas flow rate, dissolved oxygen (DO), and agitation, we can further optimize the bioprocess for product quality and productivity improvement based on biomass monitors, cell counter, metabolic analysis following Quality-by-Design (QbD) standards.

Ultimately, implementation of an optimized process at a larger lab-scale bioreactor for confirmation run ensures production processes are scalable and consistent.

Esco Aster generates production process for reliable support of our clients’ preclinical, clinical, and commercial supply, and our development experts and bioreactor engineers provide process protocols, scale-up protocol, process characterization protocol, technology transfer document, development summary report, scale-up report, risk assessment, process characterization report.

Robust and scalable production process aims at achieving a low cost, shortened timeline, high productivity, reproducibility, and consistency in drug development for the manufacture of the biopharmaceuticals for clinical and commercial production.