Purification Process Development
Source：Posted by Themecurve|
Time：2020-04-29|
Hits：3673
Service Approach
1) Recombinant protein downstream process development and OEM
2) Provide process research, pilot and enlarge scale process development
3) Provide facilities and clean environment, technical instruction and operation personnel to develop recombinant proteins extraction and purification pilot production
Production Equipment
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Extraction Unit
The extraction unit, in the Class D clean area, is composed of 2 sets of 1000L buffer preparation tanks, 3 sets of 1000L extracting tanks, pipeline system, sanitary centrifugal pump, frame filter press and cartridge filter. The buffer preparation tank can actualize buffer automatic mixing, heating and cooling, feed fluid transportation.
All tanks are washed by pure water and injection water spraying, and sterilized by pure steam.
- Ultrafiltration Unit The ultrafiltration unit is composed of ultrafiltration system and peristaltic pumps in Class C+A clean area. The Millipore manual ultrafiltration fixture, which can be installed with 2.5-5.0 square meter membrane, can be applied to various sizes of membrane pore size and ultrafiltration system. The ultrafiltration system is in the Class A clean area, which provides a good security for aseptic operation.
- Chromatographic Purification Unit The chromatographic purification unit, in the Class C clean area in accordance with GMP, is composed of 50~1000L buffer solution tanks, chromaflow 800 columns, peristaltic pumps, industrial grade UV detectors, spectrum acquisition systems and so on. The system also can match with other chromatography columns diameter from 100-800mm, such as BPG series (GE Healthcare), VERSA 450 and so on. The column packing and unpacking is performed by automatical Master Customer Asm (GE Healthcare).
- Lyophilization Unit The lyophilization unit, in the Class 100 clean area, is composed of two sets of lyophilizer, aseptic transferring window, hot and damp heat sterilization cabinet and manual packing machine etc. The products are prepared and packed in the sterile area after lyophilization. The production capacity reached 4-5kg lyophilization powder per batch.
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