The equipment used in the technology transfer process must be thoroughly evaluated. If they do not possess sufficient qualification for use in the technology transfer process, they must be modified or replaced. This equipment can be classified into four categories Research Production Equipment
This equipment is used for the initial evaluation of the cell bank and for preparing the working cell bank from the master cell bank. Some examples of this equipment include:
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Biosafety cabinet
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Pipetting Controller
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CO2 Incubator
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Water Bath
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Centrifuge
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Orbital Shaker
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-70ºC freezer
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Cool cell
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Nitrogen Tank
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Microscope
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Sampler
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Cold Room (2-8°C)
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Magnet stirrer
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Shake Flask
Pilot Production Equipment
This equipment is used to evaluate cells before full-scale production. If all predicted conditions are met at this stage, biosimilar production can proceed to the industrial phase. Some examples of this equipment include:
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Bioreactor
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Osmometer
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Cell Culture Analyzer
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Chromatography System
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Chromatography column
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Tangential Flow Filtration System
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Conductivity meter
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UV-Vis spectrophotometer
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Depth filter holder
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Cartridge filter holder
Industrial Production Equipment
The equipment in this category is similar to that used in pilot production but is designed on a larger scale compared to pilot equipment.
Equipment Related to Analysis of Intermediates and Final Products
This equipment is used for analyzing raw materials, intermediates, and final pharmaceutical products. Some examples include:
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HPLC with different detectors
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Mass spectrophotometer
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pH Meter
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Electrophoresis
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Chemical Hood
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Incubator
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Refrigerated centrifuge
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UV/Vis Spectrophotometer
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Microscope
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Plate Reader
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Particle counter
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PCR
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Centrifuge
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CO2 incubator
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Conductivity meter
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Micro-Spin Fuge/Vortex
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Gas chromatography
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Refrigerator (2-8°C)
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Osmometer
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Freezer (-20ºC)
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TOC analyzer
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Freezer (-70ºC)
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ELISA reader
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Biosafety cabinet
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Raman spectroscopy
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Karl Fischer
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Scale
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Atomic absorption
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Stability chamber
