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The cell line development team aims to shorten the overall time by providing efficient sample production for agilely developing new projects through various experiences and know-how, and shortening the development period of cell line development for CMC development and IND filling.

• hyFLEX platform: Quickly gene cloning for various types of candidates
• Fast track: High quality sample production for Fc-fusion and multi-specific structure using Transient expression system
• Stable cell line development: high efficiency stable cell line development for Fc-fusion and multi-specific structure

Our Upstream development team focuses on producing a high quality protein through advanced process development platform technology.

Upstream process development team capabilities & equipment

• Specialized experts with advanced knowledge and experience in Upstream Process Development and Tech transfer to CMO
• Facility capable of Lab scale and Pilot scale for process development
• Optimized process development platform based on titer, process robustness and reproducibility

Upstream Process Development Flow

• Clones selection

  • - Clone selection by scoring system
  • - Basal media screening
• Process development

  • - Culture parameter optimization
    (pH, temperature, DO, rpm, feed, supplement)
  • - Culture process optimization
  • - Process lock
• Process verification

  • - Robustness & Reproducibility
  • - confirmation
• Scale-up

  • - Toxicity Material production
• Tech transfer to CMO

  • - Process transfer
  • - Engineering/GMP run

The downstream process development team aims to establish and optimize high purity, high yield reproducible production processes under product quality assurance standards. For successful approval and marketing of protein drugs, we are working with global CMO and CDMO companies with cGMP facilities for the production of standardized drug substance and drug product.

The DPD team performs the following roles to improve product competitiveness through the establishment of high purity, high yield, and reproducible processes and productivity improvement.

• Optimization of the production process of durg substance and drug product through QbD technology
• Optimization of protein purification process using DoE platform
• Development of high-efficiency scale-up process
• Research on process stabilization and reproducibility improvement through risk assessment

The Analytical Lab supports CMC development through discovering optimal formulation and understanding molecular characteristic with the following capabilities

• Reducing the risk, time, and cost of CMC early stage development by identifying manufacturability and developability of candidate molecule according to TPP
• Developing formulation which leads to maintaining high product stability on Genexine own platform and performing stability testing accordingly
• Supporting product understanding and process understanding with state of the art method for physico-chemical characteristic
• Establishing DS and DP specification

QA establishes and maintains Global Quality system in accordance with ICH Q8/Q9/Q10 to have the superior technology of Genexine acknowledged by the international regulatory authorities and the global market

QA ensures that the documentations at the product development phase, after research phase, are generated within the acceptable pathway in accordance with the domestic and foreign regulations and guidelines, and performs quality monitoring for CMC development, including the active management of CDMO, to produce and supply investigational product with consistent quality and comply with relevant regulations (e.g., U.S. Code of Federal Regulations Title 21, EU guidelines on GMP for human use and their annexes, and ICH guidelines, etc.)