Research
Platform
Platform Introduction
A rare characteristic prokaryotic drug substance production platform in China, equipped with independent production lines of 500L and 2000L scales. This platform adopts E. coli and yeast expression systems, suitable for flexible production of nanobodies, recombinant proteins, microecological fermentation products, peptides and enzyme preparations.
Novel Multi-process Downstream Platform for Biopharmaceutical Fermentation (Invention Patent): It fully covers four expression modes, including intracellular soluble expression, inclusion body expression, periplasmic expression and extracellular secretory expression. It has mature experience in the R&D and commercial production of GLP‑1 analogues (such as semaglutide).
The platform is equipped with one independent microbial seed bank workshop and two independent animal cell seed bank workshops, all complying with GMP management requirements. The microbial seed bank workshop is fitted with a 0.5 m² freeze dryer for lyophilized powder preparation. The whole process is validated by APS to ensure no microbial contamination during preparation.

Service
Process & Content
Service Process & Scope
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Strain Revival01 -
Fermentation Culture02 -
Centrifugation and Homogenization03 -
Clarification Filtration04 -
Chromatography05 -
Ultrafiltration Concentration06
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Information Management
BMS/EMS systems monitor environmental parameters in real time, and the SCADA system tracks the whole process to guarantee data integrity and traceability. -
Fermentation Production
Adopts high-grade stainless steel systems. Batch capacity is 350L fermentation broth for 500L bioreactor and 1400L fermentation broth for 2000L bioreactor, with a maximum annual capacity of 60 batches respectively. -
Flexible Solution Preparation
Adopts single-use liquid preparation and storage platform to minimize the risk of contamination and cross-contamination, and enables rapid product switching to meet diverse client demands. -
High-throughput Crude Extraction
GEA / Alfa Laval cell harvesting and homogenization system ensures primary separation efficiency. -
High-efficiency Purification
Integrates ultrafiltration, hollow fiber, low/medium/high-pressure chromatography systems, and chromatography columns of various specifications (manual and automated).
Platform
Highlights
平台亮点
Nearly 3000 m² GMP-compliant drug substance manufacturing area, featuring multi-scale fermentation platforms of 50L, 250L, 500L and 2000L. The total upstream capacity reaches 100000L with a full portfolio of fermenters. Downstream is equipped with ultrafiltration systems, low/medium/high-pressure chromatography systems and various-sized columns, supporting a wide range of process scales.
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500L Fermentation Room
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2000L Fermentation Room
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Crude Extraction Room
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Purification Room
The whole process zones are equipped with explosion-proof facilities.