bioGenous Partners: Inside the “Independently Developed, Pharmaceutical-Grade” Organoid Reagent Factory
Publication Date：2024-07-01
“Scientific and Reliable” has always been the product philosophy upheld by bioGenous organoids. But how are these “Scientific and Reliable” organoid reagent products created? In the ongoing “bioGenous Partners” series on our official account, our first stop takes us to bioGenous Northern Large-Scale Production Base to uncover the secrets of this “Independently Developed, Pharmaceutical-Grade” organoid reagent factory.
Located within the National Northern Emergency Medical Industry Park in Tianqu New District, Shandong Province, bioGenous Northern Large-Scale Production Base spans 10,000 square meters. It features a 4,000-square-meter GMP-certified production workshop with a clean air handling capacity of 50,000 cubic meters per hour. After over two years of development, it has become the largest pharmaceutical-grade organoid reagent preparation and raw material production base in China and globally.
Figure 1National Northern Emergency Medical Industrial Park and bioGenous Building (right)
Figure 2bioGenous Building (10,000-square-meter Northern Large-Scale Production Base)
The high-standard construction of bioGenous Northern Large-Scale Production Base stems from three core commitments:
01 Commitment to “Pharmaceutical-Grade” Organoid Reagent Preparation, Driving Pharmaceutical Industry Development
As a revolutionary model in biomedicine, organoid technology has evolved from world-leading laboratories through industrial transformation, now serving critical sectors including research tools, new drug development, precision medicine, and regenerative medicine. However, reagents currently used for organoid culture remain predominantly at the basic research level. Their unclear raw material composition, substandard quality, and significant batch-to-batch variability severely impact organoid culture success rates and system stability. This fundamentally limits their adoption by pharmaceutical professionals and even drastically reduces the potential for translating research outcomes from basic scientists focused on drug discovery, precision medicine, and regenerative medicine.
bioGenous adheres to “GMP B+A Pharmaceutical-Grade” organoid reagent preparation and systematic quality control. We provide “multi-lineage, multi-cancer type, workflow” organoid reagents that meet the qualification requirements of international multinational pharmaceutical companies and leading domestic pharmaceutical enterprises. We also assist medical partners in applying for medical reagent qualifications, effectively supporting the expansion of organoid applications in pharmaceutical scenarios.
Figure 3: GMP Workshop and Large Air Conditioning Unit at bioGenous Northern Large-Scale Production Base
02 Core Raw Materials Developed Through Independent Innovation, Maintaining 100% Self-Controlled Production
High-quality reagent kits fundamentally rely on premium core raw materials, beyond scientific formulations and configuration processes. After years of dedicated research into pharmaceutical-grade culture media, bioGenous has achieved 100% self-sufficiency in core raw materials through independent innovation and self-controlled production. As a landmark achievement, bioGenous has fully stabilized core growth factor production for organoid culture using CHO cell lines (equivalent to antibody drug manufacturing), fundamentally eliminating batch effects with single-batch production capacity reaching hundreds of grams.
Leveraging extensive expertise in developmental signaling research and protein AI evolution tools, bioGenous scientific team has developed multiple “highly active, long-stable” engineered protein tools. These proprietary innovations, protected by international patents, significantly enhance core material efficacy.
Notably, all core material development and small-scale/pilot-scale testing are conducted within bioGenous GMP-certified laboratories, providing the most robust assurance of quality.
03 Adhering to a “fully enclosed formulation and automated filling” production system, laying the foundation for standardized and scaled organoid culture
Standardized and scaled organoid culture has long been the industry's aspiration, with the most fundamental and critical aspect being the standardized and scaled production of reagent products.
bioGenous leads the industry by establishing multiple “fully enclosed preparation and automated filling” reagent production lines within its 4,000-square-meter GMP facility. These lines intelligently complete the production of over 80 reagent kits using more than 180 raw materials. This achieves true “zero contamination throughout the process, standardized workflows, traceable quality control, and scalable production,” laying the foundation for standardized and large-scale organoid culture.
Figure 5GMP Workshop Certification at bioGenous Northern Large-Scale Production Base
Figure 6bioGenous“Fully Enclosed Preparation and Automated Filling” Production System
True to the patterns of biomedical technology revolutions, the flourishing of the organoid industry requires extensive foundational work. bioGenous will continue to uphold its vision of “Pioneer Pharma Innovation, Democratize Model Value” to build rock-solid organoid reagent products. We look forward to strengthening collaboration with bioGenous partners and industry colleagues to achieve mutual success in the future!
