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Responsible R&D
Responsible R&D
Compliance to Research Ethics
Compliance Activities for Research Ethics
SK bioscience recognizes the need for ethical compliance in the process of research and development of products. To ensure research integrity that follows the core values of science* throughout the entire research process, we document the planning, conduct, reporting, and evaluation of research, and substantiate research results based on accurate data. When handling biological materials, we strive to maintain a safe environment by establishing a biosafety committee within our R&D Center to protect the public’s health from potential risk factors. Meanwhile, SK bioscience has been designated as a Good Clinical Laboratory Practice(GCLP) facility by the Ministry of Food and Drug Safety pursuant to Article 34-2, Paragraph1, Item 2 of the Pharmaceutical Affairs Act and Article 35 of the Rules on the Safety of Drugs. As a result, all our research activities are conducted in strict compliance with Good Laboratory Practice(GLP), Good Clinical Laboratory Practice(GCLP), and domestic and international regulations. Furthermore, to maintain our GCLP status, we undergo regular examinations by the Ministry of Food and Drug Safety to assess overall performance, including the management of humanderived materials(samples). In addition, to enhance the ethics and reliability of animal testing, we define and adhere to relevant guidelines in our research. Even when experiments are conducted through external Contract Research Organizations(CRO), we have established a management system that monitors and supervises them, ensuring they operate under the same procedures and standards. Likewise, SK bioscience is constantly striving to comply with research ethics, and we continuously provide training on how to manage research output and Computer System Validation(CSV) to raise awareness among our researchers about the importance of complying with research ethics.
SK bioscience Value Chain
Research Ethics System
Strengthening Research Integrity System
By strengthening research data management, SK bioscience aims to secure the core values of objectivity, integrity, openness, and fairness that are required throughout the entire process of research and development. This means that all research results, regardless of their success or failure, must be managed to consider the positive and negative factors that the research may have on society at large. Research integrity is a critical factor in providing reliable data not only for our own products and projects but also for the C(D)MO business. While we strive to secure research integrity, we also recognize the need for digital innovation through DT/IT technology and adopt it in practice to efficiently manage research output. We also plan to introduce an Electronic Document Management System(eDMS) and a Laboratory Information Management System(LIMS) to strengthen research data management and ensure quality and data integrity. We plan to introduce systems such as the Scientific Data Management System(SDMS) and Electronic Lab Notebooks(ELN) at the Songdo Global R&PD Center in 2025. Recognizing the significance of research data management, we will update and operate research data management policies and procedures in the future.
Strengthening Research Ethics
Biosafety
SK bioscience has established the Institutional Biosafety Committee(IBC) at the R&D Center to prevent accidents that may occur while handling pathogenic organisms and to promptly take appropriate measures or provide medical treatment in the event of a biosafety incident. The committee is composed of external members who have no conflict of interest with the company, ensuring objectivity. It discusses biosafety comprehensively, considering various aspects such as science, law, safety, and corporate strategy. The IBC is responsible for reviewing and approving risk assessments for experiments that require biosafety management, such as genetic recombination experiments, and monitoring the safety management status of Living Modified Organisms(LMOs). The committee approves matters related to biosafety education, training, and health management, as well as the establishment and revision of biosafety management regulations. Through these responsibilities, the committee thoroughly reviews all aspects of research ethics and makes rational decisions. Additionally, it has established an operating manual for biosafety and management procedures, designated personnel in charge of biosafety management and a manager to provide training to relevant employees.
Institutional Biosafety Committee(IBC)
Control of Clinical Sample under GCLP
SK bioscience manages clinical trial samples collected from clinical trial subjects upon the client’s request. We also ensure that human-derived materials such as blood, body fluids, and tissues are not used for any other unintended purposes. We record and manage all processes from receipt, storage, transportation, and disposal of samples collected in clinical trials in accordance with internal procedures. In addition, qualified personnel with specialized education and training manage human-derived samples, and in case of adverse events, we promptly report on the safety and rights of subjects following response procedures.
Animal Testing Ethics Management
SK bioscience conducts animal tests from the preclinical stage to clinical trials, including tests for our COVID-19 vaccine. Additionally, commercially produced products are tested on animals to confirm their safety and effectiveness. We have established a management system to ensure ethical practices in animal testing and provide relevant training to raise the ethical awareness of those responsible for conducting the tests. Following the MFDS guidelines for the standard operation of Institutional Animal Care and Use Committee(IACUC), we founded the Animal Testing Ethics Committee for lab animal protection and ethical compliance, and have secured ethicality and reliability by adhering to laws related to animal testing. The committee deliberates on the ethical and scientific validity of animal experiments through on-site visits and guides and supervises related education and training. Furthermore, during regular bi-annual IACUC meetings, we assess the processes of using and managing laboratory animals, offer necessary advice, review the implementation of SOPs and related laws, and address any shortcomings identified by the IACUC to enhance the management system.
Animal Testing Process
SK bioscience raises ethical awareness of animal testing by requiring those in charge of animal testing to complete statutory training on lab animal handling and ethics, while also encouraging their participation in periodic training sessions. In addition, we respect the dignity of animal life by conducting deliberations based on the 3R(Replacement, Reduction, Refinement) principle when reviewing animal test plans and prioritizing alternative methods to animal testing. Moreover, through Post-Approval Monitoring(PAM), the IACUC monitors the animal testing process with the researcher to promote animal welfare and ensure the reliability and transparency of experimental results.
Detailed Implementation process
