Plasmid Production

Preclinical Grade

Research plasmids take all shapes and sizes, and they are not created equal in terms scalability. Forecyte Bio helps clients to focus on the design and delivery of the plasmids that will meet the criteria for scale-up down the road for clinical and commercial purposes.

Forecyte Bio works closely with its clients to conduct the process development work and deliver a scalable process that will be further demonstrated by engineering runs.

Our solvent-free animal-component-free process is designed to meet the requirements by regulators, and can be scaled to 300L fermentation volume at g/L titer yield. Our downstream purification using state-of-the-art column chromatography to ensure the quality meeting the high standard with > 90% super spiral purity, low endotoxin level, and low residue level (RNA, DNA, protein). Single-use fermenter and purification apparatus also warrant no cross-contamination in both the up-stream and down-stream processes.

GMP Grade

With our GMP facility in place, Forecyte is ready to provide production service under GMP conditions that meet the stringent requirements by different regulatory bodies such as FDA, NMPA, and EMA. Production scale supports clinical trials and commercial launch.

QC

Our quality is supported by our strict QA/QC policies and analytics; it includes