Endometrial cancer is the most common gynecologic malignancy in developed countries. Preclinical and clinical investigation of immunotherapy for endometrial cancer is not as advanced as for ovarian or cervical cancer. 

Epithelial ovarian cancer (EOC) accounts for 140,000 deaths annually worldwide and is the leading cause of gynecologic cancer-related mortality in the United States. Approximately, 70% of EOC patients present with advanced disease, and although the majority will respond to surgery and first-line chemotherapy, most of these responses are not durable: more than 90% of suboptimal surgically debulked patients and 70% of optimally debulked patients will relapse in 18 to 24 months. The major subtypes of ovarian carcinomas include high-grade serous carcinoma (HGSC), endometrioid carcinoma (EC), clear cell carcinoma (CCC), low grade serous carcinoma (LGSC), and mucinous carcinoma (MC). More recently, four molecular subtypes (C1/mesenchymal, C2/immune, C4/differentiated, and C5/proliferative) have been identified in HGSC and validated by gene expression profiling, and these are associated with differential clinical outcomes.

Thorough characterization and in-depth study of PK, as well as absorption, distribution, metabolism, and excretion (ADME) properties, are critical in order to support vaccine discovery and development processes for the production of safer and more effective vaccines.

Reproductive toxicity is a special part of toxicology which comprises any effect of vaccine components on reproduction and development (embryonal and fetal development). The investigations and the interpretation of the results should be related to all other pharmacological and toxicological data available to determine the risk of the test vaccines to humans. 

In vivo assays play a crucial role in the assessment of the potency and safety of human vaccines. Efficient translation from basic research to clinical therapies will depend on the availability of appropriate animal models to address every problem that arises during vaccine development.

The real-time stability test of vaccines. It is to observe and study the physical, chemical, biological characteristics and change of efficacy of the vaccine over a period of time under the expected conditions of use and preservation. Accelerated stability study is the rate of change in physical, chemical and biological characteristics of a vaccine that is placed at sequence temperature including above the actual preservation temperature. The study provides supporting data on the shelf-life or release criteria for vaccines.

It is currently determined that the key target of the protective immune response triggered by influenza vaccine immunization is hemagglutinin (HA), and neuraminidase (NA) may also play a role.

The Alternative Methods of Vaccine Potency Tests

The alternative methods include experimental animal substitution and serological substitution. The first method is to use other animals with similar clinical symptoms to replace the original animals, and indirectly test the efficacy of this animal vaccine. As for serological method, the efficacy of vaccine is assessed by detecting the antibody titer level after immunization. It involves viruses neutralizing experiments and all kinds of ELISA.

One of the most important effects of microorganisms on humans is to cause infectious diseases. Great advances have been made in the use of vaccines for disease prevention and intervention, but microbial infections continue to occur in vaccines. Therefore, it is very important to establish a standard vaccine microorganism detection platform.

The combination of chromatography with precipitation, centrifugation, and other traditional separation technologies has gradually become the main method of our vaccine separation and purification.