KR

CDMO

Your promising partner CellabMED

Our Service

Outline

Provision of process technology establishment and scale-up services for lab-scale platform tech./candidate materials

Certification staus

  • Advanced Biological Products Manufacturing Licenses

  • Certificate of GMP compliance of a biopharmaceutical contract manufacturing oranization

  • LMO Facility Approval

One-Stop Service for Advanced Biopharmaceuticals

Discovery
  • Custom manufacturing of valid/candidate/lead products
  • Target validation & candidate screening
  • Supply of research samples
  • PoC evaluation
Process
development
  • Establishment of virus/CAR-T manufacturing process
  • Process optimization
  • MCB/WCB production
  • Formulation study
Non-clinical
study
  • Process scale-up & sample materials supply
  • Preliminary toxicity and distribution studies (normal or disease animal model)
  • Efficacy evaluation (in vitro/in vivo)
  • Development of analytical methods
Clinical
study
  • GMP tech. transfer
  • Manufacturing of clinical samples
  • Quality testing & method validation
  • DS/DP stability test
Approval
  • Consulting on product characteristic and standards setting
  • Support for CMC of clinical products (IND filing)
  • Support for MFDS RA

CDMO Process

  • STEP 01

    Customer Request

  • STEP 02

    Nondisclosure Agreement

  • STEP 03

    Discussion of Project Scope

  • STEP 04

    Cost Estimate

  • STEP 05

    Contract

  • STEP 06

    Tech. Transfer /
    Scale-up

  • STEP 07

    Eng. Run & Drug Product Manufacturing