Global
CN

Microbial Express

Strain Construction and Seed Bank Creation Process Development Manufacturing PC / PV

Fermentation Process Development

LKtime specializes in advancing and refining microbial fermentation processes by leveraging DoE concepts and adhering rigorously to QbD principles. Our expertise enables us to meticulously design and optimize the fermentation processes tailored to meet the specific requirements of our clients.

Service Contents

Service Features

  • A comprehensive document quality management system that complies with both Chinese and US regulatory submission requirements.
  • Rapid completion of process development from 250mL shake flasks to 10L bioreactors, exploration and optimization of the fermentation scale-up process for the expression of existing strains through culture media composition, pH, induction methods, feeding strategies, induction duration, etc., and scaling the process up to 50L or 500L to support IND submission.
  • A comprehensive range of process characterization services are provided to support process validation and marketing authorization applications.
  • The expression of biological products generally exceeds 10g/L, while the production costs for non-glycosylated drugs can be reduced by more than 70%.
  • Main Equipment
  • Fermentation Room

  • 500L Fermentation System

  • CIP Station