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Biopharmaceutical Verification Platform Service

Located in Songjiang District, Shanghai. Total floor area 15000 square.

Production Line Configuration

l Eukaryon fermentation workshop:

1000L pilot-scale line (stainless steel)     1set

200L small-scale line (stainless steel)     1set

500L pilot-scale line (disposable)        1set

l Protokaryon fermentation workshop: 500L pilot-scale line (stainless steel)     1set

l Separation & purification workshop: continuous flow bufferfly centrifuge, AKTA chromatography system, ultrafiltration system, etc.

l Sterile injection workshop: freeze thawing machine, liquid mixing system, vial washing-drying-filling- sealing machine, freeze drier, pre-filled syringe injection production line, cartridge injection production line.

Complete conformity with EU cGMP guideline. Fully equipped analysis laboratory, testing laboratory;

Rental service of small- scale and pilot-scale macromolecular protein drug production line;

Small- scale and pilot-scale cell culture process study;

Small- scale and pilot-scale bacterial culture process study;

Small- scale and pilot-scale purification process study;

Small- scale and pilot-scale preparation process study;

Preclinical and clinical phase I, II product preparation service;

The technology in hand allow to achieve: Antibody expression titer no less than 3g/L, cell density more than 15×106cells/mL, cell viability maintained above 90% for the whole process, bacterial contamination rate approaching zero.