On November 7, the groundbreaking ceremony for the HSC-HOSTEP Stem Cell Technology Complex took place at the Hoa Lac High-Tech Park, marking a significant milestone in the field of regenerative medicine in Vietnam. GMPc Vietnam is honored to serve as the technology design and cGMP FDA consulting unit for this project.
Designed in accordance with international cGMP FDA standards (Current Good Manufacturing Practices), this complex promises to open groundbreaking treatment opportunities for numerous serious illnesses.
Mr. Dao Xuan Huong, Chairman and CEO of GMPc Vietnam, the consulting unit for cGMP FDA standards for the HSC-HOSTEP Stem Cell Technology Complex, stated: “Currently, while some hospitals and healthcare facilities in Vietnam are utilizing stem cells in treatment, healthcare, and beauty applications, this remains a new field with no specific laws or standards to ensure product quality and safety.”
The HSC-HOSTEP Stem Cell Technology Complex is the first stem cell project in Vietnam to be certified as a high-tech project by the Ministry of Science and Technology.
The completion of all legal procedures to begin construction by Hoa Lac Stem Cell Technology Joint Stock Company (HSC) marks a crucial step forward, solidifying HSC’s pioneering position in Vietnam's pharmaceutical-biological and regenerative medicine industries.
The project has two main functions:
1. Stem Cell Banking: Includes the storage of stem cells derived the umbilical cord blood of newborns.
2. Testing, Standardization, Research, Training, and Technology Transfer Center: This means HSC is not a competitor but a critical partner for hospitals and medical facilities that apply stem cell technology..
The HSC-HOSTEP Stem Cell Technology Complex provides the foundation and infrastructure necessary for the development of stem cell technology, meeting the growing demand hospitals and healthcare facilities while positioning Vietnam as a research and application hub for stem cell technology in the region.
As the cGMP FDA standards consulting firm, GMPc Vietnam has made specific contributions to the project to ensure the stem cell complex produces products that meet international standards for safety and quality.
According to Mr. Dao Xuan Huong, the cGMP certification by the FDA (Current Good Manufacturing Practices issued by the U.S. Food and Drug Administration) is among the most stringent production standards in the healthcare and pharmaceutical field.
To achieve this certification, the facility must comply with strict regulations regarding infrastructure design, equipment installation, production processes, and personnel training, all of which are inspected and approved by the FDA.
This rigorous process requires meticulous preparation to ensure the project meets safety standards and achieves effective product outcomes.
In its role as the comprehensive cGMP FDA consulting unit for the HSC-HOSTEP Stem Cell Technology Complex, GMPc Vietnam will accompany HSC throughout the project’s lifecycle: From concept design to detailed design. The process of selecting and validating design, equipment installation, operation, and performance. Building cGMP-compliant systems and documentation. Finally, assisting HSC in passing FDA inspections and evaluations.
Once the HSC-HOSTEP Stem Cell Technology Complex receives FDA cGMP certification, its stem cell products will have global value, ensuring compliance with safety and efficacy requirements in various ries.
This represents a significant advancement, not only raising domestic production standards but also opening new opportunities for Vietnam in the field of regenerative medicine.
However, Mr. Dao Xuan Huong also acknowledged that the biggest challenge faced by GMPc Vietnam and HSC in building a cGMP FDA-compliant complex is the rigorous effort required to achieve FDA cGMP certification. This is particularly challenging as no stem cell facility in Vietnam currently meets these stringent standards.y.
Of the 300 facilities in Vietnam certified with WHO GMP, only 14 meet advanced GMP standards such as Japan GMP, PIC/S GMP, or EU GMP, and none have achieved FDA cGMP certification.
This highlights that cGMP FDA is the most demanding standard, requiring strict compliance in all aspects, infrastructure design and technology to quality management systems.
The greatest challenge faced by GMPc Vietnam and HSC lies not in infrastructure, equipment, or quality management system investments but in technology.
To receive cGMP certification, the stem cell complex must produce FDA-compliant products, meaning the technology must be FDA-approved and in circulation in the U.S.
This requires HSC to either develop FDA-compliant technology internally or secure technology transfer agreements with partners already offering FDA-approved stem cell products.
“With experience and thorough preparation, we are confident that the project will overcome this barrier to meet the highest standards of quality and safety,” said Mr. Dao Xuan Huong.
Commenting on the potential of stem cell technology development in Vietnam and the prospects of future advanced projects like the HSC-HOSTEP Stem Cell Technology Complex, Mr. Dao Xuan Huong emphasized:
“Stem cell technology is a vital field in biotechnology with tremendous development potential, particularly in treating severe diseases”.
GMPc Vietnam Joint Stock Company is currently Vietnam’s No. 1 consulting firm, aiming to rank among the Top 3 in ASEAN in comprehensive consulting for investment projects in GMP-compliant pharmaceutical, cosmetic, health food, veterinary medicine, and aquatic drug manufacturing facilities.
As a pioneering comprehensive consulting firm for GMP-compliant project investments, GMPc Vietnam provides end-to-end solutions, ensuring clients only need one consulting partner to complete their GMP investment projects while meeting the criteria of Smplification - Cost optimization - Certification assurance..
GMPc Vietnam’s consulting team includes experienced GMP managers, specialists, pharmacists, engineers, and biochemistry graduates with extensive GMP practice experience at large-scale facilities domestically and internationally, striving to: Understand GMP – Understand Your Needs!
Current consulting services offered by GMPc Vietnam include:
Investment project development consulting
EU GMP Pharmaceutical Factory Consulting
WHO GMP Pharmaceutical Factory Consulting
ASEAN cGMP-Standard Cosmetic Factory Consulting
HS GMP Health Supplement Consulting
WHO GMP Veterinary Pharmaceutical Facility
GSP Warehouse Consulting
Good Distribution Practices (GDP) Certification Consulting
Over 14 years of development with offices in Hanoi and Ho Chi Minh City, GMPc has earned the trust of nearly all GMP-compliant manufacturing facility investors nationwide, completing almost 300 certified GMP facilities—acing for over 80% of the projects invested in 2011–2024!.
All investors have been satisfied, and the projects have been highly rated by state management agencies. Hundreds of partners, leading GMP brands, and facilities in Vietnam, including DHG Pharma, Mediplantex, Vinmec, FPT, Linh Huong Cosmetics, TopWhite, Dang Duong, Codupha Pharmaceuticals, and Hapharco, have chosen GMPc as their consulting firm.
Contact Information:
GMPC VIETNAM JOINT STOCK COMPANY
- Head Office (Hanoi): No. 32, Vi Cam 5 Street, An Lac Urban Area, Van Canh, Hoai Duc, Hanoi
- Tel: 0243.787.2242 | CEO Hotline: 0982.866.668
- Email: contact@gmp.com.vn
- Ho Chi Minh City Office: Floor 2, No. 156/1/1 Cong Hoa, Ward 12, Tan Binh District
- Tel: 0283.811.7383
