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▶ Integrated service of the production of recombinant proteins and DNAs for clinical application by
turn-key base contract
▶ Affiliate program with KBCC in cooperation for the cGMP contract manufacturing service
(* Source : Following descriptions were originated from the website http://kbcc.kitech.re.kr) |
A. Types of Biopharmaceutical Manufactured
 Proteins (Native and Recombinant)
Monoclonal antibodies
Antibody fragments |
B. Contract Manufacturing Service
Cell Banking : Master & working cell banking, Cell line characterization
API Manufacturing :
1) Fermentation and Cell culture
- 500L Fed-batch type microbial fermentation
- 500L Perfusion-type mammalian cell culture
. Technology support
. High-density microbial fermentation technology
. Perfusion-type mammalian cell culture technology
. Recovery technology
. Validation technology
2) Purification
- A broad scale of purification from pre-clinical stage
- Technology support
. Purification process development and optimization technology
. SOP & validation technology |
C. Fill/finished Biopharmaceuticals Manufacturing
Liquid vial production (2ml, 6ml, 10ml vial)
Freeze-dried vial production (2ml, 6ml, 10ml vial)
Pre-filled syringes production (1ml, 3ml syringe)
Technology support
Freeze-dried cycle optimization technology
Validation technology
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▶ Quality Control Certificate
▶ Documentations, Record Reviews, Internal Audit, Review for Release
▶ Regulatory Submission : CMC Section Support and DMF
▶ VMP, DQ/IQ/OQ/PQ, SOP(Cleaning/Environment/Sterilization/Analysis)
▶ Performance Qualification and Process Validation
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▶ We act as a representative of our customer to manage the project of cGMP production in KBCC and cooperate with KBCC to fulfill the requirement of cGMP regulation by auditing the operation of cGMP process and inspecting the production plant. We do all functions including the transfer of production protocols to KBCC, the audits, the inspections, the analysis & QC, and monitoring the performance of CMO on behalf of our customer until we complete securely the production of samples.
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