Mammalian Cell Culture Services
Mammalian cell culture is a fundamental technique essential for studying cellular biology, disease mechanisms, and drug responses, as well as for producing biopharmaceuticals like vaccines and therapeutic proteins. Building on decades of experience in cell culture, Avance Biosciences offers comprehensive GMP-compliant cell culture service, ensuring strict quality control and compliance with regulatory standards for biologics testing.
Mammalian Cell Culture Services
Application
Description
Cell-Based Potency Assays
Mammalian cell cultures are crucial for assessing the biological activity and potency of biologic drugs. These assays help determine if the biologics meet specified potency requirements, ensuring their effectiveness in treating targeted diseases.
Cytotoxicity Testing
Cell culture techniques are used to evaluate the potential toxic effects of biologic drugs on mammalian cells. By exposing cultured cells to varying concentrations of the drug, researchers can assess its safety profile and identify any adverse effects that may impact patient health.
Immunogenicity Testing
Mammalian cell cultures play a pivotal role in evaluating the immunogenicity of biologic drugs. These tests assess whether the drug induces an immune response in cultured cells, providing insights into potential adverse reactions and guiding strategies to mitigate immunogenicity risks.
Stability Testing
Cell culture systems are utilized to evaluate the stability of biologic drugs under different storage conditions (e.g., temperature, humidity). By monitoring the integrity and activity of the drug over time, researchers ensure that it maintains its therapeutic efficacy and meets regulatory stability requirements.
Genetic Stability Testing
Biologic drugs produced using mammalian cell lines undergo genetic stability testing to ensure the consistency and reliability of cell line performance. These tests assess whether the genetic characteristics of the cell line remain unchanged over successive passages, minimizing the risk of genetic instability and ensuring product quality.
Virus and Adventitious Agent Testing
Mammalian cell cultures are used to detect and quantify potential viral contaminants or adventitious agents in biologic drugs. These tests are crucial for ensuring product safety and compliance with regulatory guidelines, protecting patients from potential infections associated with biological products.