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[Press Release] PCMO Successfully Concludes the Expert Network Event on Innovative New Drug Material

-Held on November 5 at PCMO in Hwasun, Jeonnam… Co-organized with Hwasun Chonnam National University Hospital▲ Group photo of innovative new drug materials expertsPCMO (Director Min Cho, hereafter referred to as the Center)in Hwasun, Jeonnam, announced the successful conclusion of the "Innovative New Drug Materials Expert Network" event, co-hosted with Hwasun Chonnam National University Hospital on November 5.The event aimed to introduce the "Innovative New Drug Materials Commercialization and Core Nonclinical Proof-of-Concept Support Project," co-managed by Hwasun Chonnam National University Hospital and the Center. Attendees included pharmaceutical and biotechnology industry stakeholders, and the event provided an opportunity to explore potential collaborations, build networks among participants, and discuss the shared use of infrastructure and the development of new projects.Participants included directors and managers from 12 companies who discussed the potential for joint projects in a dedicated networking session. Numerous companies expressed a keen interest in the Center’s facilities and the details of the project, leading to active discussions and some preliminary business partnership talks.▲ Tour of the production facilities at PCMOThe "Innovative New Drug Materials Core Nonclinical Proof-of-Concept Infrastructure Development Project" is led by Hwasun Chonnam National University Hospital, in collaboration with the Center. This initiative will receive approximately 7.2 billion KRW (USD 5.4 million) in national and local government funding by 2027, with the goal of building a testbed for blockbuster drug development and supporting commercialization to aid pharmaceutical companies in developing new drugs.Located in the Hwasun Vaccine Industry Special Zone, the Center provides CDMO (Contract Development and Manufacturing Organization) services for pharmaceuticals using microbial technology and is currently constructing a facility for mRNA pharmaceutical CDMO services, which is expected to be completed by the second half of 2025. With support from the Ministry of Trade, Industry, and Energy and Hwasun County in Jeonnam, this facility will allow Korea to secure the capacity to manufacture vaccines for the entire population in the event of a national emergency.

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[Press Release] PCMO Successfully Concludes IVI-WHO ‘Global Bio Workforce Training Hub’ Program

- Hands-on training conducted at the Microbial Commercialization Support Center in Hwasun, Jeonnam, from October 31 to November 1 - 23 trainees from 16 countries participated, contributing to enhanced global vaccine and biopharmaceutical quality management skills▲ Group photo of trainees at PCMOPCMO (Director Min Cho, hereafter referred to as the Center)announced the successful completion of the "2024 Vaccine and Biopharmaceutical Quality Management (GxP) Basic Training," a component of the "Global Bio Workforce Training Hub (GTH-B)" program, led by the International Vaccine Institute (IVI). This program hosted 23 trainees from 16 different countries.The two-day training was held in the Hwasun Vaccine Industry Special Zone and focused on hands-on exercises designed to give trainees practical experience. Participants gained hands-on skills in microbial culture and purification processes, physicochemical and microbiological testing, and the use of VR-based culture process programs essential for the manufacturing and quality management of vaccines and biopharmaceuticals.The curriculum was designed according to the Ministry of Food and Drug Safety's ‘Good Manufacturing Practice (GMP)’ and EU GMP’s ‘Annex 1 (Aseptic Manufacturing Requirements),’ offering participants a training aligned with global pharmaceutical standards. Emphasis was placed on helping trainees from diverse backgrounds and countries to understand these global standards. Industry experts delivered lectures based on their field experience, which were well-received by the trainees.▲ VR culture process training session▲ Storage facility tourThe training was conducted at PCMO as well as other facilities in the Hwasun Bio-Specialized Complex, including the Jeonnam Bioindustry Foundation's Biopharmaceutical Research Center and the Vaccine Safety Technology Support Center. Around 70 global trainees traveled to Hwasun, Jeonnam, for this program, marking significant progress since Hwasun's designation as a Global Bio Campus in July 2023.PCMO is running a "Vaccine Industry Professional Training Program," funded by the Ministry of Trade, Industry, and Energy and Hwasun County, Jeonnam, with plans to train over 900 graduates by 2026. With a new training and residential center slated for completion in early 2025, more robust training programs are expected next year.The IVI's "Global Bio Workforce Training Hub (GTH-B)" is a program launched in collaboration with the Ministry of Health and Welfare and the World Health Organization (WHO) in 2022. The program has provided training to over 800 professionals thus far, and with the recent establishment of the GTHB Support Foundation and the upcoming Global Bio Campus (GBC), it aims to further strengthen vaccine manufacturing capabilities in low- and middle-income countries.

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[Press Release] PCMO Completes Chosun University GMP Training with 'VR On-Site Training'

- The 3-week training ran from July 22 to August 9, providing an experience of cGMP-grade facilities in Hwasun, Jeollanam-do.- The training included VR on-site education, offering both GMP facility experience and cultivation process training.▲ Photo of Professor Choi Cheol-ung from Chosun University with the 15 graduates.PCMO (Director Min Cho, hereinafter referred to as the Center) announced on the 14th that it successfully completed a 3-week GMP training program for 15 students from Chosun University's Department of Biomedical Science and other related departments. This training took place at PCMO's facility located in the Hwasun Vaccine Industry Special Zone, featuring a curriculum that combined theoretical and hands-on training. The program utilized PCMO’s latest GMP facilities and engaged participants through industry trends and discussions with current employees. The curriculum was designed based on the ‘Good Manufacturing Practice (GMP)’ standards set by the Ministry of Food and Drug Safety, aimed at making it easy for students to understand through a balance of theory and practice. The training included the following components: ▲ Basic GMP education ▲ Validation and equipment verification ▲ Theory and tour of the manufacturing site ▲ Theory and practice of utility (facility management) ▲ Quality Control (QC) education ▲ VR (Virtual Reality) cultivation process trainingExperts in each field delivered lectures based on their on-site experience. Notably, this training introduced a VR education program for the first time, which attracted significant interest from the students. The VR program, developed through the 'Vaccine Industry Manpower Training Project' funded by the MOTIE(Ministry of Trade, Industry, and Energy) and Hwasun County, was designed to effectively provide virtual tours and equipment practice. The overall satisfaction score for the training was 90.6, reflecting high approval. Satisfaction with the VR training’s difficulty level was particularly high at 97, confirming that students gained substantial field experience through VR.▲ Photo of the VR cultivation process training session. Additionally, PCMO conducted a survey with the 15 trainees regarding job search and educational aspects. Most trainees cited completing training at a certified institution and gaining research experience as their primary goals. Considerations for applying included the training curriculum, location, feedback from previous graduates, and nearby public transportation.Some trainees remarked, "The integration of theory and practice made the training more memorable," and noted that "The in-depth content and the experiences shared by experts in their respective fields were very beneficial." PCMO plans to train over 900 graduates by 2026 through the 'Vaccine Industry Manpower Training Project,' which is supported by the Ministry of Trade, Industry, and Energy and Hwasun County. The completion of the new training and dormitory facility, scheduled for the first half of 2025, is expected to support vibrant educational programs in the coming year.

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[Press Release] PCMO Partners with MirimGENE Co., Ltd. to Develop Tuberculosis Treatment

-Targeting the tuberculosis treatment market, projected to reach approximately $3 billion (₩4.13 trillion) by 2030… Aiming at a high-risk disease with a 12% mortality rate▲ PCMO-MirimGENE Co. logoPCMO (Director Min Cho, hereafter referred to as the Center) announced on the 16th that it is collaborating with MirimGENE Co., Ltd. (CEO Mirim Jin) to jointly develop a ‘recombinant protein treatment for tuberculosis’ based on an innovative drug platform targeting WARS1 (Tryptophanyl tRNA synthetase 1).WARS1 is an endogenous human factor that is secreted into the blood from monocytes within minutes of infection, activating innate immunity.MirimGENE Co., Ltd. has been the first in the world to elucidate the immune activation function and mechanism of action of WARS1 and is developing a first-in-class innovative drug targeting it. MirimGENE Co., Ltd. possesses a robust pipeline of treatments not only for tuberculosis but also for over-inflammatory sepsis, rheumatoid arthritis, atopic dermatitis, and other autoimmune and rare diseases, as well as infectious diseases, using its proprietary new drug development technology with the WITheranostics platform (WARS1 targeted-Immune disorder Theranostics).The Center, with its extensive experience in various contract development and manufacturing (CDMO) projects since obtaining GMP certification in 2021, will cooperate to accelerate the research and development of MirimGENE Co., Ltd.’s tuberculosis treatment and bring it to market. The Center has significant experience in tuberculosis vaccine research and development, instilling confidence in the success of this project.Meanwhile, the market for tuberculosis treatment, targeted by MirimGENE Co., Ltd., is expected to grow to approximately $3 billion (₩4.13 trillion) by 2030. According to the World Health Organization’s 2022 Global Tuberculosis Report, approximately 10.6 million people were infected, with the death toll reaching 1.3 million, highlighting the high mortality rate and the critical need for new drug development.

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[Press Release] PCMO Participate in BIX 2024, Showcasing Advanced mRNA Services

- To be held at COEX in Seoul from July 10th to 12th, with participation from global pharmaceutical companies such as Samsung Bioepis, Lonza, and Merck.▲ PCMO Booth Design ModelPCMO (Director: Min Cho, hereafter referred to as the Center) has announced its participation in BIOPLUS-INTERPHEX KOREA 2024 (BIX 2024), to be held from July 10th to 12th at COEX in Gangnam, Seoul.At BIX 2024, PCMO will promote its core CDMO (Contract Development and Manufacturing Organization) services and showcase advanced technologies in vaccine and biopharmaceutical manufacturing. Particularly, the PCMO will unveil plans for the mRNA vaccine and biopharmaceutical manufacturing facility scheduled to operate from 2025, attracting global biotech industry attention.Since its establishment, PCMO has been supporting domestic companies in their global ventures and promoting the vaccine industry. Located in the Hwasun Vaccine Industry Special Zone, the PCMO has successfully completed 100 projects. Besides CDMO services, it provides support to mRNA vaccine companies and offers tailored on-site training services with the backing of the Ministry of Trade, Industry, and Energy and Jeollanam-do Province.At the PCMO booth, visitors can receive consultations on various CDMO services, including microbial-based manufacturing, process development, formulation research, and cell bank manufacturing, in capacities of 50L, 200L, and 1,000L. Additionally, the PCMO aims to contribute to the development of the domestic bio industry through networking with industry stakeholders.▲ PCMO Booth Location GuideBIX 2024, co-hosted by the Korea Biotechnology Industry Organization and Reed Exhibitions Korea (RX Korea), will feature participation from 250 companies across 15 countries. The event will showcase diverse fields, including manufacturing and facilities, biotechnology, laboratory equipment and analysis, raw materials (pharmaceuticals, food, cosmetics), cold chain logistics and packaging, services (clinical, preclinical, consulting), digital healthcare, and hospitals, universities, and public institutions.Key side events include company presentations on the Open Innovation Stage, partnering matches, a startup awards ceremony, and a global IR session with domestic and international venture capitalists (VCs). These activities are designed to provide opportunities for Korean bio companies to enter overseas markets and offer insights for building a global network.

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[Press Release] PCMO participates in WHO Global Training Hub Mini Convention

-June 11, Seoul National University Siheung Campus with SK Bioscience, Thermo Fisher, ST Pharm, and other companies▲PCMO PT sessionPCMO (Director: Min Cho, hereafter referred to as the Center) announced on the 12th that it promoted its CDMO (Contract Development and Manufacturing Organization) and workforce training programs to 175 representatives from vaccine-related companies and institutions from 49 countries at the WHO (World Health Organization) Global Training Hub - BIO(GTH-B) Mini Convention, organized by the International Vaccine Institute (IVI) at Seoul National University Siheung Campus.The WHO Global Training Hub - BIO program, established in 2022 through collaboration between the Ministry of Health and Welfare and WHO, is now in its third year of operation. It was initiated to enhance global vaccine and biopharmaceutical production capabilities in response to COVID-19. Through this program, 175 participants from government agencies and companies related to vaccines from 49 countries received comprehensive training, including the entire vaccine production cycle theory, discussions and case studies, and site visits to domestic companies from June 3 for two weeks at Seoul National University Siheung Campus.The Mini Convention was organized to introduce domestic companies that could not be visited due to schedule and distance constraints and to broaden the perspectives of the trainees. The event was a great success with participation from domestic companies such as SK Bioscience, Thermo Fisher Scientific, ST Pharm, Beyondcell, and institutions like the Korea Biomedicine Industry Association, including the Center.▲PCMO Poster PT sessionAt the Mini Convention presentation session, the Center introduced its CDMO services, including microbial-based manufacturing at scales of 50L, 200L, and 1,000L, process development, formulation research, and cell bank manufacturing. Additionally, the Center announced that it would operate a manufacturing facility for mRNA vaccines and biopharmaceuticals, which have gained attention due to COVID-19, starting in 2025, drawing significant interest from global industry stakeholders.Furthermore, the Center promoted its educational program aimed at training professionals in vaccine and biopharmaceutical manufacturing. Supported by the Ministry of Trade, Industry and Energy, Jeollanam-do Province, and Hwasun-gun County, this program aims to produce 900 graduates by 2026, addressing the industry's demand for skilled bio professionals.The relationship between the International Vaccine Institute (IVI) and the Center has been ongoing for seven years. Since signing a Memorandum of Understanding (MOU) in 2018 to promote the supply of safe and effective vaccines for infants in developing countries, the two organizations have maintained continuous collaboration. Since the start of the WHO Global Training Hub - BIO program in 2022, the Center has regularly participated in company visits and Mini Convention events.Jinyoung Song, Head of External Relations, who introduced the Center in the presentation session, stated, “It was a meaningful opportunity to showcase the capabilities of the domestic vaccine industry,” and added, “We hope that global biopharmaceutical regulatory officials will recognize the strength of Korea's capabilities.”