Biopharmaceuticals

Fermasol™ Fermentation System for Biopharmaceuticals

Application Overview

Fermasol™ Fermentation System is a high-end industrial microbial fermentation platform fully compliant with cGMP, ASME BPE and international biopharmaceutical manufacturing standards. Optimized by CFD fluid dynamics simulation, the system integrates high-efficiency aeration, low-shear stirring structure, multi-parameter linkage intelligent control and fully automatic CIP/SIP sterilization functions. It is widely suitable for submerged fermentation and high-density culture of engineered E. coli, recombinant yeast, filamentous fungi, actinomycetes and various industrial microbial strains in the biopharmaceutical industry.

The whole equipment covers laboratory process development, pilot scale-up and commercial mass production, perfectly supporting the R&D and industrial manufacturing of recombinant protein drugs, polypeptide medicines, interferons, growth factors, monoclonal antibody fermentation raw materials, antibody fragments, microbial vaccines, live bacterial preparations and other high-value biopharmaceutical products.

Biopharmaceutical fermentation has extremely strict requirements on sterile environment, parameter stability, batch repeatability and strain activity protection. Fermasol™ achieves real-time precise locking of temperature, pH, dissolved oxygen, stirring speed, ventilation volume, tank pressure and foam level throughout the whole process. It supports batch fermentation, fed-batch fermentation and continuous fermentation modes, effectively optimizing microbial growth and metabolic pathways, increasing cell density and target product expression titer, and ensuring stable quality and consistent performance of biopharmaceutical products in different batches.

Core Performance Advantages

• Customized impeller and aeration structure designed according to the physiological characteristics and metabolic rules of biopharmaceutical strains.

• Low-shear fluid design protects fragile engineered strains, prevents cell lysis and activity decline, and improves fermentation expression level.

• High-precision sensors and PID intelligent control ensure small parameter fluctuation, fully meeting pharmaceutical process validation requirements.

• 316L pharmaceutical-grade stainless steel with mirror polished inner wall, no dead angle, no residue, effectively avoiding cross-contamination.

• Equipped with automatic CIP online cleaning and SIP in-situ sterilization, realizing unattended long-term sterile fermentation production.

• Complete data collection, storage and audit trail functions, complying with 21 CFR Part 11 data integrity and global regulatory filing standards.

• Modular skid-mounted design enables seamless scale-up from lab to commercial production without repeated process debugging.

Industry Application Value

Fermasol™ Fermentation System has become the preferred core equipment for biopharmaceutical enterprises, research institutes, university laboratories and professional CDMO/CMO production platforms. It greatly shortens the R&D cycle of new biotech drugs, accelerates clinical trial progress and market launch pace. At the same time, it significantly improves fermentation yield, product purity and batch qualification rate.

With high operational stability, intelligent automation and complete regulatory compliance, the system reduces labor costs, energy consumption and production failure risks. It helps biopharmaceutical enterprises build standardized, intelligent and fully compliant fermentation production lines, and strongly promotes the innovative development and industrial upgrading of the global biopharmaceutical industry.