CDMO BUSINESS Advanced cell / gene-based biopharmaceutical development and CDMO

ENCell Co., Ltd. established and maintains premier GMP facilities meeting up to
global standards for cell/gene therapy products.
We provide customized pharmaceutical development services,
from early development stage to approval stage.

CMOConsignment production of leading biopharmaceutical products

Production of biopharmaceutical product for (pre)clinical trials in compliance with KGMP upon client’s requests
Leading biopharmaceutical product manufacturing : Multiple source-derived stem cells (Placenta, Wharton’s jelly, Adipose tissue and Bone marrow etc.), CRISPR-stem cell, Exosome, AAV
Aseptic Process Validation
Cell characterization: Cell growth, Differentiation potency, Anti-inflammatory effect, Immunogenicity, Cell phenotype etc.
Essential testing including sterility testing for cell/gene therapy
Safety testing ( long-term storage)

CDOConsignment development of leading biopharmaceutical products

Consultations on development of manufacturing processes, quality testing for (pre)clinical trials of biopharmaceutical products
Specification of the cell culture and manufacturing methods
Establishing large-scale culture methods according to GMP standards
Consultations on IND approval
Establishing test standards for incoming raw materials for production
Setting up donor tissue suitability test and IPC criteria standardization
Quality control criteria establishment
Procure stable packaging and long-term storage system
Service Scope
We provide services according to the product development stage upon client’s request

Service Process Flow

  • STEP.01Client request

  • STEP.02NDA agreement

  • STEP.03Consulting
    service scope

  • STEP.04Cost estimation

  • STEP.05Contract agreement

  • STEP.06Pilot production

  • STEP.07Consignment production and R&D

  • STEP.08Shipment