R&D capability of global
bio company Genexine

CMC Development

CMC
Development
In order to develop various hyFc-fusion protein drugs, our CMC development activities cover from cell line development to manufacturing process development, employing Hybrid Fc platform. Our CMC department covers the full spectrum of technical capabilities, including new cell line development, cell culture and purification process development, analytical and formulation development, non-clinical efficacy, safety evaluation, pilot plant manufacturing and QA. Currently high qualified clinical material is manufactured in cGMP CMO through technology transfer. All hyFc-fusion protein pipelines under clinical development have been developed by our own development system regarding cell lines, manufacturing processes, analytical methods and formulations, leading to more than ten (10) pipelines. Based on technical know-how and expertise accumulated in the process of developing more than 10 pipelines, additional multi-specific fusion protein pipeline is currently being developed.
Cell Line Development Team

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
  • Vector Cloning
  • Transfection
  • Screening of pool clones
  • Single cell Cloning
  • Clone evaluation
  • Selection of RCB candidate
  • Long-term stability study
Upstream Development Team

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
Downstream Development Team

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
  • High purity
    &
    High yield
  • QbD/DoE based
    process
    optimization
  • High efficient
    Scale-up Process
    development
  • Risk assessment
  • Process
    robustness
    maximization
Analytical Development Team

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
  • Method development & Validation
    • - Quantity
    • - Impurity
    • - Identity
    • - Potency
    • - Glyan profile
    • - Charge variant
    • - Excipient
    • - Purity
  • Characterization
    • - Primary structure
    • - High order structure
    • - Post-Translational modification
  • Experimental study
    • - Forced degradation study
    • - Structure-Activity Relationship Study
    • - Stability study
    • - Comparability study
    • - Formulation study
Quality Assurance Team

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.)

R&D Quality System
  • - Cell Line/Process/Analysis Method Development
  • - Non-clinical Material Manufacturing
  • - R&D Document Management
  • - Training Management
  • - IND dossier Management
GMP Quality System
  • - CMO/CRO Audit and Qualification
  • - Technology Transfer
  • - Investigational Product Manufacturing /Test/Release Management

Non-Clinical Development

Non-Clinical
Development

The scientific team at non-clinical has extensive experience evaluating MoA and efficacy of the drug with the selection (or development) of appropriate animal models and various assays, as well as collaborating to design to meet optimal results of pharmacological action based on the biological properties of hyFc platform drugs. In addition, the team conducts toxicology studies with various global GLP institutions such as Korea, Europe, the United States, and Japan. Based on the non-clinical research results, technical support is provided to predict the dose level and adverse effects of clinical trials. Non-clinical laboratory is designated as a clinical study sample analysis laboratory by the Korea Ministry of Food and Drug Safety and supports clinical study sample analysis.

    • Drug candidate design
    • MoA and Pharmacological Study for drug candidate
    • PK, PD study for the clinical trial preparation
    • Toxicology study for clinical translation
    • Clinical development Strategy Support
    • IND/IMPD documentation
    • Analytical support for clinical sample

DNA Vaccine

DNA Vaccine

Process Research Team

Our Process Research Team aims to develop for price competitiveness and global top-level pDNA manufacturing process

  • High productive cell bank
  • Optimization of fermentation process
  • Development of high yield purification process

Analysis Team

Analysis team create the value of the Products through the pDNA quality control and product characterization, and perform the non-clinical trial to secure PoC(Proof of Concept) for clinical trials. Based on these, CTD package of pDNA product is established for IND and BLA

  • Method development, Validation and Technology transfer
  • Quality control and Characterization for Product
  • Non-clinical trial (PD/BD, Efficacy study, Toxicity study, and etc.)
  • IND/BLA packaging and approval (CMC and Non-clinical)

Production Team

Production team create the value of the Products through the pDNA manufacturing to support Non-clinical and clinical study. Based on these, CTD package of pDNA product is established for IND and BLA

  • Non-GMP Manufacturing
  • Process Optimization for GMP Technology Transfer
  • GMP Technology Transfer and Manufacturing product for clinical trial
  • IND/BLA packaging and approval (CMC)

pDNA manufacturing technology