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.
Our Upstream development team focuses on producing a high quality protein through advanced process development platform technology.
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.
The Analytical Lab supports CMC development through discovering optimal formulation and understanding molecular characteristic with the following capabilities
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.)
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.
Our Process Research Team aims to develop for price competitiveness and global top-level pDNA manufacturing process
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
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