On March 13th, Caixin reported that relevant departments of the National Health Commission are organizing a consultation with experts on the release of egg freezing for single women. Egg freezing technology refers to the freezing and ultra-low temperature storage of oocytes applied in assisted reproductive medicine. Although there is currently no open egg freezing for healthy unmarried and childless women in China, the related issues of promoting the development of assisted reproductive technology have already received widespread attention from industry insiders in the face of declining fertility rates and increasing public demand. With the gradual deepening of research and the increasing maturity of technology, it has been proven that the use of safe and mild reagents for assisted IVF procedures can effectively improve survival rates. At present, WEGO's independently developed Vitrification Kit [CFDA(ZZ)20233180341], Warming Kit [CFDA(ZZ)20233180372], Sperm Washing Medium [CFDA(ZZ)20233180343], and hepes-HTF [CFDA(ZZ)20233180345] have all obtained three types of medical device registration certificates issued by the National Medical Products Administration. The four words “overcoming difficulties” cannot be avoided in every link of their research and development, technology, management, clinical practice, production and other processes. Even if they encounter many difficulties and slow progress, they have never thought of taking shortcuts or lowering requirements. We believe that only by striving for excellence in every detail and deeply cultivating, can we achieve the goal of “making ethnic assisted reproductive medical care”. Quality assurance of 'developing with autonomy'.
In 2005, WEGO, with the aspiration of reducing patient medical expenses and giving autonomy to the development of ethnic assisted reproductive medicine, resolutely devoted itself to the research and development of assisted reproductive products. It was the first to obtain the registration certificate for domestic assisted reproductive medical consumables and became a writer of industry standards.
The establishment of the culture medium project in 2009 marked the beginning of WEGO's first research and development of assisted reproductive culture medium in China. During this period, “fast” and “good” became common choices faced by the entire team: to gain an advantage in the market or to carefully polish the quality? WEGO chose the latter. The alchemy of time, rigorous scientific verification, and professional talent operation are the indispensable methods for forging product quality.
After initiating the mouse embryo experiment, the liquid research and development project team has twice dispatched personnel to study mouse embryo experiments at the Guangzhou Institute of Biomedical and Health Sciences and the Institute of Zoology, Chinese Academy of Sciences. They have continuously optimized the operation process of mouse embryo experiments, updated experimental micro operation tools, and explored the fastest and most convenient technical methods for collecting embryos. The company's experimental animal personnel must hold certificates and establish detailed and standardized standard operating procedures for in vitro mouse embryo testing and experimental animal feeding. Ensure fresh drinking water and food for experimental animals, comfortable living environment, health monitoring and epidemic prevention during breeding, while providing a strict and standardized in vitro mouse embryo quality control system for the company's entire assisted reproduction product line.
Given the essential differences between mouse embryos and human embryos, mouse embryo testing can only provide a preliminary assessment of product safety. However, to determine the effectiveness and further safety of the product, clinical validation is still necessary. Therefore, we have collaborated with the Reproductive Center of the Third Affiliated Hospital of Guangzhou Medical University and the People's Hospital of Wuhan University. Through years of clinical trials and effect tracking, the main evaluation is the complete survival rate and clinical pregnancy rate after use, and follow-up is conducted until fetal birth. The live birth rate is calculated, and the conclusion is drawn that there is no significant difference in the complete survival rate, clinical pregnancy rate, and live birth rate between WEGO culture medium and international brand control group products after use.
Regarding life, how to make products “good”, “better”, and even “very good” has always been the theme throughout the development process of WEGO culture medium. From the production environment to the improvement of ingredients, we have always strived for the “best”.
Embryo culture medium protects the safety and health of embryos, but is the culture medium itself safe? The composition of the culture medium is complex, and subtle parameter fluctuations or external interference can produce unpredictable effects. How to ensure the safety, freshness, balance, and pollution-free nature of the culture medium? WEGO strictly controls the production environment and strives for excellence.
On the one hand, the factory is located in Weihai, Shandong Province, which is renowned for its ecological reputation nationwide and even globally. Its two most prominent features are good air quality and excellent water quality, making it a city with no heavy pollution weather throughout the year and rich in negative oxygen ions in the air. The superior water quality is related to the unique geographical location of the city facing the sea on three sides. The advantages of air and water quality not only stem from the gifts of nature, but also from the fact that Weihai people treat ecological protection with almost strict requirements and have already become a conscious group. These are reflected in the products, which are the external environment's support for production and the good concepts and habits cultivated by personnel.
On the other hand, WEGO Assisted Reproduction has over 3000 square meters of ISO13485 certified purification workshops, over 500 square meters of 10000 level purification workshops, 30 square meters of 100 level purification areas, and 300 square meters of quality control areas, ensuring a stable and reliable internal production environment. Each process of the product undergoes strict testing, with each product inspected under a microscope one by one. Each type of product undergoes batch by batch component testing, batch by batch biological testing, and batch by batch mouse embryo testing to ensure that the product has no quality issues and consistency between batches.
Knowing the importance of culture medium as the “life-saving water” for in vitro fertilization, WEGO dare not relax and can only strive for excellence. In addition to the complexity of the design, it is also necessary to select appropriate and necessary ingredients, and ensure the purity and naturalness of the environment, minimizing stress on the embryo as much as possible, in order to maintain or even improve the developmental potential of the embryo during in vitro culture.