STANDARD MANUFACTURING

GMP-cGMP Standardisation

Cell Standardization and GMP/cGMP-Compliant Stem Cell Technology

SABC is committed to building a GMP/cGMP-compliant stem cell ecosystem that integrates cell banking, advanced manufacturing, quality assurance, and translational research, enabling the delivery of safe, high-quality, traceable, and globally competitive stem cell and regenerative medicine products.

Stem cell-based therapies are being successfully implemented across numerous hospitals, while a rapidly expanding stem cell market outside the regulatory framework, reflecting strong public demand for standardized regenerative medicine.

Aligned with FDA 21 CFR Part 1271, cGMP regulations, EU GMP guidelines, ATMP standards, and international quality frameworks including ISO 20387, FACT, and AABB, SABC is committed to delivering trusted, scalable, and clinically compliant cell-based products and technologies for local healthcare needs and global impact.

Hoa Lac stem cell manufacturing platform (HOSTEP) is the stem cell R&D and manufacturing center of the SABC–HLP Stem Cell Ecosystem, established on the foundation of SABC’s existing operations at Hoa Lac High-Tech Park.

GMP-cGMP MANUFACTURING

SABC established a stem cell technology laboratory at Hoa Lac High-Tech Park and organized a national workshop to advocate for the implementation of a stem cell technology development program.

2002.

2011

SABC and TAGC/INSERM U1090 (Luminy Science Park, France) signed a Memorandum of Understanding (MoU) to establish and advance stem cell technologies at Hoa Lac Hi-Tech Park, witnessed by the Ministry of Health and the Ministry of Science and Technology (MOST).

2024

Establishment of Hoa Lac Stem Cell JSC (HSC) and Groundbreaking Ceremony for the Hoa Lac Stem Cell Technology Park (HOSTEP) in the R&D Zone of Hoa Lac Hi-Tech Park.

https://drive.google.com/file/d/1eClwNV8gzmR22kAcmk5Ox1Uhqu9YZep3/view?usp=sharing

http://hhtp.gov.vn/en/tin-tuc/hoa-lac-hi-tech-park-groundbreaking-for-stem-cell-technology-research-project-1766.html

Together with the Central Vaccine Institute, SABC-HLP has a monkey breeding facility on an isolated island in Ha Long Bay to serve vaccine research and pre-clinical trials.