Bioprocess Development & Scale-Up
Bioprocess Development & Scale-Up
As the critical bridge between molecule discovery and large-scale manufacturing, we provide end-to-end process development services — from the construction of high-expression strains, through fermentation/purification process development, to stepwise scale-up and validation at laboratory and pilot scale.
Service Positioning
:As the critical bridge between molecule discovery and large-scale manufacturing, we provide end-to-end process development services — from the construction of high-expression strains, through fermentation/purification process development, to stepwise scale-up and validation at laboratory and pilot scale. We address the process scale-up bottlenecks that arise when translating laboratory results into industrial production, delivering a mature process package that is robust, cost-effective, and compliant, and directly ready for large-scale manufacturing. Each process-stage service can be purchased separately; alternatively, we offer an integrated, end-to-end development service from strain construction through to the pilot-scale process package — helping clients shorten the path to industrialization and reduce manufacturing-side costs and risks.
Data Tables
| Service Model | Service Content |
|---|---|
| Strain Development | Selects the optimal expression system based on protein characteristics (E. coli / Pichia pastoris / Bacillus subtilis / mammalian cells, etc.), and completes codon optimization, vector construction, screening of high-expression transformants, and strain passage-stability validation, delivering high-performance production strains. |
| Fermentation Process Development | For clients' existing strains, optimizes culture media, culture conditions, and feeding/induction strategies from shake-flask up to 50 L bioreactor scale; resolves issues such as low expression, inclusion bodies, and protein degradation. |
| Purification Process Development | Develops efficient, scalable purification routes tailored to client requirements: optimizing cell disruption/solid–liquid separation conditions, selecting appropriate chromatography media and buffer systems, optimizing elution conditions, removing impurities, improving purification yield and protein purity, and enhancing stability; delivers standardized purification process protocols. |
| Pilot Scale-Up & Validation | At 100–1,000 L scale, addresses scale-up effects such as mass transfer and shear; establishes the ranges of critical process parameters and quality control standards; completes three consecutive pilot production runs for validation; delivers a mature process package ready for direct commercial manufacturing, along with kg-scale samples. |