CRO service

Engineering bacteria construction

According to customer needs, construct qualified engineering bacteria

Establishment, verification and stability of secondary strain library

Including the establishment of the main generation seed bank and the working seed bank, the detection of plasmid loss rate, expression level and passage stability, to confirm the stability of seeds.

Quality standard and method establishment

Formulate the most suitable quality standards for strains and expressions to ensure the validity and authority of the quality standards; establish and deliver a complete set of quality standards and testing methods according to customer needs and conditions.

Methodological validation and sample testing

Validation of biochemical and microbial testing methods and the development of physicochemical, biochemical and microbial testing items for biological products.

Fermentation pilot process development, process optimization and confirmation (2L, 10L, 30L)

According to the results of the small-scale process test, optimize the fermentation process, find the most suitable fermentation process, and submit it to the customer for confirmation

Purification pilot process development, process optimization and validation, formulation screening

According to the confirmed fermentation process and existing equipment, develop a suitable purification process, and screen the final composition and proportion of the preparation to ensure the effectiveness, stability and safety of the drug.