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[Press Release] PCMO Completes GMP Training with Chosun University

- Two-week training from January 9 to January 22, featuring hands-on experience at a cGMP-grade facility in Hwasun, Jeollanam-do▲ Chosun University’s Department of Biomedical Sciences Chair, Seokjun Kim, Professor Chulwoong Choi, and 15 program graduatesPCMO in Hwasun, Jeollanam-do (Director Min Cho, hereinafter referred to as the Center) announced on the 24th that it has successfully completed a two-week GMP training program for 15 students, including those from the Department of Biomedical Sciences at Chosun University, from January 9 to January 22.The training was conducted at the Center, located in the Hwasun Vaccine Industry Special Zone, and featured a curriculum combining theoretical instruction with hands-on field training. By utilizing the Center’s state-of-the-art GMP facilities, the program engaged participants through practical training, industry trend analysis, and networking sessions with industry professionals.The curriculum was designed based on the Good Manufacturing Practice (GMP) standards set by the Ministry of Food and Drug Safety (MFDS), ensuring a balanced mix of theoretical and practical education. Training topics included: - Introduction to GMP fundamentals - Validation and equipment qualification - Manufacturing site theory and facility tours - Utilities (facility management) theory and hands-on training - Quality control (QC) training - VR-based bioreactor process training Expert instructors, drawing from their field experience, led the sessions to enhance participants' understanding of GMP operations.The comprehensive blend of theory and hands-on experience resulted in an overall satisfaction score of 95.9%. Notably, hands-on training with bioreactors, purification equipment, and QC testing received exceptionally high praise, achieving a satisfaction score of 98.▲ Hands-on training in bioreactor cultivationSome participants shared their feedback, stating, “The training was highly practical, allowing us to experience real-world operations,” and “The insights from industry professionals on job interviews and workplace expectations were extremely valuable.”The Center is set to launch a large-scale workforce development initiative with the opening of a new training facility in June 2025, as part of the Vaccine Industry Professional Training Program supported by the Ministry of Trade, Industry, and Energy and Hwasun County, Jeollanam-do. The goal is to train and graduate more than 900 professionals by 2026.Scheduled for completion in June 2025, the new training center will be the largest GMP training facility in the Gwangju-Jeonnam region. Equipped with advanced training infrastructure, it aims to serve as a hub for nurturing experts in the biopharmaceutical industry. Along with the designation of Hwasun as a specialized biotech cluster, the facility is expected to significantly enhance GMP capabilities in the region and drive the growth of the advanced bioindustry.

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[Press Release] PCMO Advances Next-Gen Japanese Encephalitis Vaccine Development

- Advanced recombinant VLP production platform enables superior quality compared to first-generation vaccines▲ Logos of Vaxdigm, Catholic University of Korea College of Medicine, and PCMOPCMO (Director: Min Jo) located in Hwasun, Jeollanam-do, announced on the 3rd that it has partnered with Vaxdigm (CEO: Sungjae Kim) and the Department of Microbiology at the Catholic University of Korea College of Medicine (led by Professor Sangwook Suh) to develop a next-generation Japanese encephalitis vaccine.By the first half of 2025, PCMO plans to enhance manufacturing processes to enable large-scale production in GMP facilities, based on research findings secured by Vaxdigm and the Catholic University of Korea. As vaccine safety and regulatory approval are critical in clinical trials, this phase marks a pivotal stage in the end-to-end drug development process.The next-generation Japanese encephalitis vaccine employs recombinant virus-like particle (VLP) production technology, offering improved productivity and quality control compared to first-generation live and inactivated vaccines. Recent studies reveal that the current vaccines are ineffective against the dominant genotype 5 Japanese encephalitis virus circulating in Korea, further underscoring the urgency of developing new vaccines.▲ Panoramic view of PCMOFounded in 2021, Vaxdigm is a pioneering biotech venture leading innovative vaccine development using its proprietary microbial-based rapid protein antigen production platform. This groundbreaking technology delivers superior stability and cost-effectiveness, equipping the company with a competitive edge in the next-generation vaccine market. In addition to the Japanese encephalitis vaccine, Vaxdigm is actively working on developing vaccines to counter future pandemics, including influenza vaccines.Since its establishment in 2017 with support from the Ministry of Trade, Industry and Energy and Hwasun County, Jeollanam-do, PCMO has successfully developed processes for over 30 products. It renewed its GMP certification in November 2024, further solidifying its role as a public CDMO (Contract Development and Manufacturing Organization).Representatives from Vaxdigm and Professor Sangwook Suh's team at the Catholic University of Korea disclosed plans to submit an Investigational New Drug (IND) application to Korea's Ministry of Food and Drug Safety in 2025. They emphasized the necessity of new vaccine development, citing the high mortality rate of genotype 5 Japanese encephalitis virus and the low protective efficacy of existing vaccines.According to UNICEF's Japanese Encephalitis Market Report, the global Japanese encephalitis vaccine market is projected to grow from KRW 3.2 trillion in 2023 to KRW 5.5 trillion by 2031. The successful development of this next-generation vaccine is expected to capture this increasing market demand.

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[Press Release] PCMO Signs MoU with BXPLANT for Comprehensive Pharma Development Collaboration

- CDRO and CDMO integration to drive full-cycle pharmaceutical development collaboration▲ BXPLANT CEO Min-geun Jo and PCMO Director Min Cho at the MoU SigningPCMO (Director Min Cho, hereafter referred to as the Center) announced that it has signed a Memorandum of Understanding (MoU) with BXPLANT (CEO Min-geun Jo, Hee-seon Kim) on December 3rd, aiming for comprehensive collaboration in the full cycle of pharmaceutical development.The main objective of this MoU is for the two organizations to share the latest trends in the pharmaceutical CDRO (Contract Development and Research Organization) and CDMO (Contract Development and Manufacturing Organization) industries, and to establish a collaborative network throughout the entire pharmaceutical development process. BXPLANT plans to combine its CDRO services with PCMO's manufacturing technologies and production capabilities to enhance the domestic bio industry and secure competitiveness in the global bio market.BXPLANT provides CDRO services to domestic biotech venture companies, offering full-cycle support from clinical development strategy formulation to preclinical and clinical phases. The company also plans to expand its role as a "scalerator," focusing on company discovery, investment attraction, and consulting for capital raising, thus actively supporting the growth of biotech companies.PCMO plans to complete the construction of mRNA vaccine production facility by the first half of 2025, and based on its accumulated experience from over 100 projects, it will further strengthen support for domestic pharmaceutical and bio companies. Since its establishment in 2017, with investments from Ministry of Trade, Industry and Energy and Jeonnam-do Hwasun County, PCMO has been continuously supporting the development of domestic vaccines and biopharmaceuticals.▲ Logos of BXPLANT and PCMOThrough this collaboration, the two organizations aim to build a full-cycle collaboration network based on their respective expertise, expanding technological innovation and growth potential in the bio sector. As global biotech companies have been actively investing in the CDRO and CDMO markets in recent years, the future developments of the two organizations are expected to be highly promising. Meanwhile, BXPLANT CEO Min-geun Jo emphasized, "Through our collaboration with PCMO, we aim to combine our CDRO services with manufacturing and production capabilities, elevating the level of the domestic bio industry and strengthening our competitiveness in the global market. This MoU is not just a business agreement but an important starting point that will help accelerate the growth of the biotech ecosystem."

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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.