Hemolysis is the breakdown or destruction of red blood cells (RBCS), resulting in the release of hemoglobin and other cellular contents into the surrounding environment. The analysis of cell hemolysis is very important for injectable liposomes because it fully represents the biocompatibility of injectable liposomes. The platform of CD Formulation supports the hemolysis experiments of injectable liposomes and provides systematic analytical services for the development and quality control of injectable liposomes.

Why Conduct Injectable Liposome Hemolysis Testing?

Hemolysis refers to the reaction of hemolysis and red blood cell aggregation caused by drug preparations. The hemolytic reaction includes immune and non-immune hemolysis, which is related to the safety of liposome preparations. Because liposome injection contains phospholipids and is complex in composition, blood cell aggregation can be produced after injection into blood vessels. Adverse reactions such as immune hemolysis and blood circulation dysfunction caused by immune reactions should also be excluded. Therefore, all injections and other drug preparations that may cause immune or non-immune immunoreaction should be subjected to hemolytic tests.

Fig.1 Basic mechanism of hemolysis. (Luna-Vázquez-Gómez R, et al., 2021)

Our Services for Injectable Liposome Hemolysis Testing

Hemolysis testing services include in vitro tests and in vivo tests.

In Vitro Hemolytic Testing

The mechanism of the hemolysis reaction is complex. Currently, there is no established preclinical in vivo test for comprehensive evaluation of the hemolytic response to liposomal injections. Therefore, we develop a serial program to investigate the hemolysis of such liposome injections without reference preparations in long-term toxicity studies. During the test, we will focus on the pertinent indicators and signs of hemolytic reaction (such as reticulocyte, red blood cell count, bilirubin, urine protein, nephritis, splenic congestion, etc.). If hemolysis occurs, further study should be conducted. For liposome injections already on the market with the same route of administration, we use the conventional in vitro test tube method to evaluate the hemolysis of the drugs. If the results of the in vitro test tube test are positive, further comparative studies will be conducted with the preparations on the market with the same route of administration, and if necessary, animal tests will be conducted in vivo.

In Vivo Hemolysis Testing

If the results of hemolysis in vitro are positive, we will conduct hemolysis tests in animals or combine them with repeated drug toxicity tests to evaluate the hemolysis effect of drugs in vivo and further explore the hemolysis mechanism according to the requirements of the guiding principles for the development of injection liposomes. In addition, we infer the correlation between hemolysis response in animals and hemolysis response in humans, thus suggesting the risk of clinical trials with an injection of liposomes.

Fig.2 Workflow of injectable liposome hemolysis testing. (CD Formulation)

Our Platforms for Injectable Liposome Hemolysis Testing

We offer professional facilities and technology platforms for customers to meet their needs and requirements.

Our Key Advantages in Injectable Liposome Hemolysis Testing

• Scientific experimental scheme. According to customer requirements, our professional scientists customize scientific and reasonable experimental programs to meet the hemolysis testing requirements of various injectable liposomes.
• Advanced technologies and platforms. Utilizing advanced techniques and platforms to meet the various needs of customers. Our laboratory can meet different requirements of hemolysis experiments in vivo and in vitro to support for liposome drug development.

Published Data

CD Formulation has formulated a complete program of formulation optimization, drug administration, in vivo sample collection, and quantitative analysis of biological samples from skin, which can efficiently complete experiments, provide accurate and reliable data, and facilitate the drug development process of skin administration. If you need any kind of assistance, please contact us immediately.