Celltrion

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Fields of Research

R&D Leader in the Field of Biologics Established for Leading the Country in Biotechnology

Biologics Development

Selection of candidate antibodies following screening and Proof of Concept (PoC) studies

Candidate Antibody Discovery

Target Molecule Screening

  • Selection of the target indication and target molecules
  • Feasibility test of the target molecules

Candidate Antibody Selection

  • Selection of candidate antibodies through various screening methods

Identification of the Mechanism of Action (MoA) of Each Selected Candidate

  • Verification of efficacy through in vitro and in vivo studies
  • PoC studies

Cell Line Development

Cell Line Development

Genetic Expression and Amplification System

  • Development of high-producing cell line via gene integration and amplification
  • Enhancement of transcription and translation efficacy of target proteins

Final Clone Selection through Stability Test

  • Clone selection based on quality, productivity, and stability

Proprietary Cell Line Development Technology

  • Patented expression vector (MarEx Vector), human cell line (F2N) and related patents

Optimization of Cell Culture and Purification Process

Cell Culture Process Development

Cell Culture Media Development

    • In-house development of various cell culture media formulations
    • Media optimization technology to improve productivity and product quality
    • Media screening technology for efficient selection of cell culture media

Cell Culture Process Optimization

  • Optimization using various cell lines (CHO, sp2/0, NS0, human, etc.)
  • Optimization of cell culture parameters using the Design of Experiment (DoE) approach
  • Platform technology for obtainment of high productivity and control of product quality

Characterization of the Cell Culture Process for Commercialization

  • Scale-up/scale-down studies and pilot culture model studies
  • Process characterization studies
  • Technology transfer to commercial plant and troubleshooting

Purification Process Development

Purification Process Optimization

  • Optimization of recombinant protein purification from animal cell culture
  • Optimization of recombinant protein purification from bacterial cell culture

Development of Accelerated Purification Process for Obtaining High Purity and High Yield

  • Resin and buffer screening and determination of the most efficient order of purification steps
  • Optimization of purification parameters using the Design of Experiment (DoE) approach

Characterization of the Purification Process for Commercialization

  • Scale-up and pilot studies
  • Impurity and virus clearance studies for securing safety
  • Resin and membrane lifetime studies

Analytical Methods Development and Evaluation of Quality

Analytical Methods Development and Evaluation of Quality

Comprehensive Analysis of Physicochemical and Biological Attributes

  • Assessment of physicochemical and biological attributes through orthogonal methods
  • Evaluation of product quality from the process development stage to product approval

Analytical Method Development

  • Establishment of the analytical variables
  • Evaluation of the suitability of each method
  • Establishment of standard procedures

Identification of Mechanisms of Action (MoA) and Conformation of Comparability

  • Development of analytical methods to evaluate MoA
  • Assessment of biological comparability before and after process changes

Formulation Development

Formulation Development

Initial Formulation Development Studies

  • Determination of conditions for optimal stability (pH, buffer system, excipients, etc.)
  • Assessment of protein stability when exposed to various external conditions
  • Development of stability-indicating assays for detection of degradation products

In-Depth Formulation Development Studies

  • Optimization and characterization of the selected formulation
  • Identification of degradation products under stressed conditions and verification of the critical formulation components
  • Assessment of degradation pathways via forced degradation studies

Stability Studies

  • Performance of stability tests under long-term, accelerated, and stressed conditions
  • Identification of key physicochemical attributes affecting efficacy
  • Evaluation of the suitability of the container closure system

Pharmaceutical Evaluation

Non-Clinical Studies

Pharmacodynamics

  • Evaluation of receptor binding affinities
  • Assessment of biological activities using cell-based assays
  • Assessment of biological activities in vivo
  • Tissue cross-reactivity studies

Pharmacokinetics

  • Evaluation of Pharmacokinetics and Toxicokinetics (pharmacokinetic comparability studies)
  • Estimation of effective human dose from human PK and animal PK/PD

Toxicology

  • Evaluation of toxicity (NOAEL, HNSTD, etc.) through various studies including assessment of general toxicology and local tolerance
  • Identification of organ toxicity

Fields of Research and Development

Biosimilars

Therapeutic agents against
cancer and autoimmune diseases

Therapeutic Agents Against Cancer
Breast Cancer, Large Intestine Cancer, Pancreatic Cancer, Cervical Cancer, Non-Hodgkin’s Lymphoma, Chronic Lymphocytic Leukemia, etc.
Therapeutic Agents Against Autoimmune Diseases
Rheumatoid arthritis, Psoriasis, Ankylosing Spondylitis, etc.

Novel Therapeutic Agents

Antibody Therapeutic Agents, Vaccines, Fusion Technology, Natural Product Therapeutic Agents, Recombinant Proteins, Platform Technology

New Antibody Drugs
Infectious Diseases, Cancer, Autoimmune Diseases
Vaccines
Viral Diseases, Bacterial Diseases
Fusion Technology
ADC(Antibody-Drug Conjugate)
Natural Product Therapeutic Agents
Novel Therapeutic Agents based on Natural Products and Functional Materials
Recombinant Proteins
Anticoagulants, Metabolic Diseases, Adjuvant Therapeutic Agents for Cancer
Platform Technology
Fc Engineering Technology, Bispecific Antibody Technology, Antibody Screening Technology
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