Gene synthesis

Vector construction

Original strains

Construction of the original strain library

Construction of the secondary strain library

Fermentation process development

Purification process development

Preparation process development

Quality Standard Establishment

Analytical Method Development

Analytical Method Transfer and Validation

7L-2000L fermentation scale

Meet different production needs

Aseptic preparation filling

Product release

Improve quality control system

Improve quality assurance system

Comply with legal and regulatory requirements

IND application

NDA application

International application

(FDA, EMA)

Registration service consultation

Commercial production