Addressing the biopharmaceutical industry's exceptionally rigorous requirements for sterile environments and process stability, we offer comprehensive process packages spanning the entire workflow—from cell culture (upstream) to protein purification and formulation (downstream). Our solutions strictly adhere to GMP design standards, empowering clients to significantly shorten the transition cycle from R&D to clinical-scale production.
Key Logic
Strain/Cell Expansion → Scaled Fermentation → Separation & Purification → Formulation & Processing
Advantage
Fully recognizing the critical importance of "data traceability," our core equipment supports comprehensive audit trails. Furthermore, we assist clients in completing IQ/OQ/PQ validation protocols, thereby ensuring that production processes remain both compliant and transparent.
Process Flow
-
01Upstream CultureKey EquipmentBioreactors / Fermenters / IncubatorsDescriptionProvides sterile, temperature-controlled, and oxygen-rich environments for bacterial or cell expansion.
-
02Cell DisruptionKey EquipmentUltrasonic Cell DisruptorsDescriptionExtracts target products, such as intracellular proteins and antigens.
-
03Midstream HarvestingKey EquipmentHigh-Speed Tubular Centrifuges / CentrifugesDescriptionHarvests microbial biomass or clarifies secreted fluids from culture media.
-
04Sample ConcentrationKey EquipmentVacuum Concentrators / Nitrogen ConcentratorsDescriptionGently concentrates biological samples while preventing protein denaturation.
-
05Formulation & ProcessingKey EquipmentFreeze Dryers / Steam Sterilizers (Autoclaves)DescriptionPrepares lyophilized powder injectables; ensures the sterility of all materials and equipment in contact with the product.
-
06Environment/StorageKey EquipmentBiosafety Cabinets / Liquid Nitrogen Tanks / RefrigeratorsDescriptionEnsures personnel safety; facilitates the long-term preservation of valuable microbial strains and cell lines.
-
07Quality ControlKey EquipmentTotal Organic Carbon (TOC) Analyzers / Ultrapure Water SystemsDescriptionMonitors the purity of process water; supplies ultrapure water for laboratory applications.
Customers Cases
-
Bioreactor Fermentation Process Optimization System
ApplicationE. coli fermentation or mammalian cell culture, using a bioreactor to precisely control pH, DO, and temperature to optimize expression.Key EquipmentBioreactor Fermenter + Incubator -
High-Concentration Protein Harvesting System
ApplicationClarifying and collecting target proteins (bacterial cells or secreted proteins) from fermentation broth, using a high-speed tubular centrifuge to achieve efficient solid-liquid separation.Key EquipmentHigh-speed tubular centrifuge + Diaphragm Pump + Filter -
Vaccine Virus Concentration System
ApplicationFor live viruses (e.g., influenza, COVID-19 vaccines), using a vacuum concentration centrifuge for gentle, non-denaturing concentration.Key EquipmentVacuum concentrator centrifuge + ultrasonic cell disruptor -
GMP Compliance Formulation Filling Support System
ApplicationDispensing and pre-treatment of sterile materials in a biosafety cabinet, followed by final steam sterilization.Key EquipmentBiosafety cabinet + steam sterilizer + clean bench