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GMP原核及酵母原液生产

基于独立微生物种子建库车间+特有专利发酵后处理多工艺平台
保障零偏差、高合规原液供给

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
  • Strain Revival
    Strain Revival
    01
  • Fermentation Culture
    Fermentation Culture
    02
  • Centrifugation and Homogenization
    Centrifugation and Homogenization
    03
  • Clarification Filtration
    Clarification Filtration
    04
  • Chromatography
    Chromatography
    05
  • Ultrafiltration Concentration
    Ultrafiltration Concentration
    06
  • 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
Flexible Line Configuration

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.

  • 500L Fermentation Room
  • 2000L Fermentation Room
  • Crude Extraction Room
  • Purification Room
Explosion-proof Design

The whole process zones are equipped with explosion-proof facilities.

Upstream:A dedicated explosion-proof storage workshop is set up for methanol and ammonia water storage.
Downstream:Equipped with explosion-proof reversed-phase chromatography room. All chromatography and solution preparation systems in this area meet explosion-proof requirements.
Downstream Processing:Complete facilities for organic solution treatment are available with environmental assessment approval.
Advanced Production Equipment

Adopts world-leading brands including GEA and Alfa Laval. Independent air conditioning control is configured for fermentation, crude extraction, CIP/SIP and purification zones of each production line.

  • GEA Homogenizer
  • Alfa Laval Disc Stack Centrifuge
  • Solution Preparation System