세포바이오 로고 세포바이오 로고

PRODUCT

GMP

GMP Center of CEFObio is operated by obtaining the advanced pharmaceutical manufacturing license and the human cell management business license from the Ministry of Food and Drug Safety.After registering our factory in October 2020, we have been producing and controlling the quality our company's Phase 1 and 2 clinical drugs on our own.We operate three independent manufacturing plants and the testing laboratories consisting of a virus laboratory, mycoplasma laboratory, sterility laboratory, and physical &chemical laboratory.In addition, the GMP Center is comprised of the excellent personnel with the extensive industry experience and plays a key role in the development of the advanced biopharmaceuticals.

GMP Service

GMP Center of CEFObio has its own IND experience and theTrack record of consignment services for the various government agencies and large corporations.Based on our advanced biopharmaceutical manufacturing and quality control system, we will become the optimal partner for small and medium-sized bio-venture pharmaceutical production.

  • Competent

    Competent

    Our deep understanding and know-how about cells is our core competitiveness.We have experience in the consignment production of numerous MCB, WCB, and exosome DP.

  • Quality

    Quality

    We are aiming for the global standard by establishing the strict quality control system under the pharmaceutical manufacturing license and GMP certification.

  • Reliable

    Reliable

    Rather than carrying out the multiple projects simultaneously, we focus on one success story.From IND to clinical trial, we want to be the trustworthy partner in the mid to long term.

  • Optimum

    Optimum

    We support our customers in optimizing Tech transfer through the close collaboration between R&D and GMP.

CMO/CDMO

  • CMO/CDMO

  • Cell Banking

    · Construction of MCB and WCB

    · Quality test for characteristics analysis

    GMP production

    · Technology transfer and Pilot study

    · Aseptic process validation

    · ENG run

    · DS/DP GMP production

    Process development

    · Process optimization for GMP introduction
    -Verification of sterility and reproducibility

    · Scale-up process development

    Quality test

    · Test method validation

    · Receipt test for raw material/raw ingredient

    · Long-term stability test

    Regulatory/
    licensing support

    · IND filing support

    · Provision of CMC related documents

    Storage

    · Storage conditions establishment for LN2 and Deepfreezer as well as storage

    · Transport validation

Service Process

  • 01

    Request & CDA

    Request & CDA

  • 02

    Scope & Service fee

    Scope & Service fee

  • 03

    Contract

    Contract

  • 04

    Development Services

    Development Services

  • 05

    Technical Transfer

    Technical Transfer

  • 06

    Pre-clinical&Clinical Production

    Pre-clinical &
    Clinical Production

  • 07

    Storage / Logistic services

    Storage / Logistic services