Our Advantage

CAR-expressing NK cells for cancer therapy

Production Capability

The purpose of the production department is not to accept, manufacture or deliver nonconforming products.

As an upstream company in cell therapy and molecular diagnosis, stringent requirements for “safety” and “capacity” have been put forward for YOCON products due to their nature. To maximally achieve the goal of “absolutely sterile” production quality, the company has built several large-scale, standardized and high-end automatic unattended production lines, which are equipped pharmaceutical-grade injection water system, CIP, sterilization and dispensing system, automatic high-speed filling system, and automatic blister packaging system.

To fully guarantee the daily capacity of 3,000 L for serum-free cell culture products and 400,000 virus sampling products, with quality and quantity assured. YOCON’s recognition of high quality production determines its high level of production quality.The purpose of the production department is not to accept, manufacture or deliver nonconforming products.

R&D Capability

The company has the core technology by making continuous and independent innovation.

As technological innovation is the fundamental driving force for enterprise development, YOCON always adheres to the R&D policy of being “safer, more convenient and more economical”, and has been perfecting its technology over the years. For the molecular diagnostic product line, YOCON has independently developed rare “Class II” virus sampling kits, lysis-free nucleic acid extraction reagents, and automatic sample processing and nucleic acid extraction workstations in China.

For the cell therapy product line, it has successfully developed dozens of cell culture reagents such as serum-free media for MSC and NK cells, gentle digestive enzymes for stem cells, and serum-free cell freezing medium. It can be called the pioneer of serum-free culture product in China.

The protein-free chemically defined medium and automatic cell culture workstation under development are in the final stages, and their launch will bring new changes. The R&D facilities of the company cover an area of 3,000 m2, with 9 Class 10,000 clean GMP laboratories. Two physicochemical laboratories are available. The laboratories are equipped with Shimadzu ultra-fast triple quadrupole liquid chromatography mass spectrometer, BD and Agilent flow cytometer, fluorescence quantitative PCR instrument, large bioreactor, fluorescence inverted microscope, biosafety cabinet, etc. YOCON Biology has the core technology by making continuous and independent innovation to make continuous progress in the fields of cell therapy and molecular diagnosis.

mesenchymal stem cells used for tissue regeneration

mesenchymal stem cell related therapies for cartilage lesions

QC Capability

The company imposes strict control of the product quality by adhering to the policy of “fairness, scientificity, accuracy and rationality”.

YOCON Biology firmly believes that product quality is the cornerstone of enterprise development and adopts the quality policy of “quality first”. The QC department imposes strict control of the product quality by adhering to the policy of “fairness, scientificity, accuracy and rationality”, and establishes a perfect quality management system. For the molecular diagnostic product line, the company has established the SOP for product inspection according to the Quality Management Standard for Medical Device Production to standardize the inspection and ensure the product quality.

For the cell therapy product line, the company has established a professional serum-free medium QC program according to the Chinese Pharmacopoeia to control the safety of cell culture. The company will make every effort to improve the level of quality testing of biological products, to reassure our customers with professional and detailed data for the purpose of more standardized development.

Base Construction

With the continuous support of our vast user base over many years, in May 2024, Yocon officially commenced production at its R&D and production base in Zhongguancun Industrial Park, Miyun District, Beijing. This base, which took three years to build and cost 250 million, is now operational.

The park has a total gross floor area of 42,000 square meters, with a purified area of 12,000 square meters. It boasts seven production lines for liquid cell culture media, one for freeze-dried preparations, two for FEP cell culture bags, two for sampling tubes, one for rapid nucleic acid extraction, one for molecular testing, and one for equipment assembly.

Upon reaching full production capacity, the annual output will be 8.33 million viral sampling kits, 120,000 bottles of serum-free cell culture media, 150,000 FEP biopolymer bags, and 100 fully automated cell culture workstations.

All production equipment has been built to meet the regulatory requirements of both the National Medical Products Administration (NMPA) of China and the US Food and Drug Administration (FDA). The entire production line achieves B+A grade static and dynamic cleanliness for aseptic filling, with dedicated lines strictly prohibiting cross-production. It meets the internal audit requirements of the GMP-level quality management system and perfectly supports the hardware requirements for more customers to simultaneously file drug applications and produce drugs in both China and the United States.

Hardware Facilities

The factory is equipped with a direct-fired machine room capable of producing 2.5 million kcal of heating and cooling capacity, maintaining stable workshop temperatures at all times to ensure production quality.

The purified water and water for injection preparation systems utilize double-stage reverse osmosis and electrodeionization modules, which are fully disinfectable. The equipment columns and tube bundles are made of seamless steel pipes from domestic top-tier brands, without welding seams, ensuring precise and stable product water outlet temperatures. This guarantees energy-saving optimization for the entire water for injection preparation and supply system.

serum free medium for antibody production

The factory boasts top-tier global automated filling production lines and management systems, with the entire line achieving B+A grade static and dynamic cleanliness for aseptic filling. The room air exchange rate exceeds 50 times per hour, and the leak detection rate of high-efficiency filters is greater than 99.97%, ensuring product safety.

Each workshop and laboratory is equipped with an independent air filtration system. After passing through three levels of filtration, the air fully meets the requirements of a B+A grade GMP production environment in terms of temperature, humidity, cleanliness level, and air outlet volume.