Analytical method development is a critical process in biopharmaceutical research and production. It involves designing, optimizing, and validating methods to accurately measure and analyze the properties of biological products. These methods are essential for ensuring product quality, safety, and consistency across batches. Companies rely on analytical method development to meet regulatory requirements and maintain high standards throughout the manufacturing process.
The Role of Custom Assay Development
Custom assay development complements analytical method development by providing specialized testing solutions for unique production systems. Each biopharmaceutical product may require tailored assays to monitor specific attributes such as host cell protein or host cell DNA levels. Custom assays are designed to fit the characteristics of the target molecule and the production environment, ensuring precise and reliable results. Through custom assay development, laboratories can streamline quality control, reduce variability, and enhance reproducibility.
ExCell Bio’s Approach to Analytical Method Development
ExCell Bio offers professional services in analytical method development and custom assay development for biopharmaceutical applications. The R&D teams at ExCell Bio have extensive experience in kit development, focusing on host cell protein quantitation and host cell DNA quantitation for various host cells and production processes. By developing exclusive kits, ExCell Bio supports clients in achieving accurate measurement results suitable for clinical declaration.
Key Advantages
The analytical methods and custom assays provided are compliant with regulatory standards and maintain GMP-like quality control. They are designed to be stable and reliable, providing confidence in data accuracy and reproducibility. With these services, laboratories and manufacturers can implement robust testing methods while optimizing their workflow efficiency.
Conclusion
Analytical method development is a fundamental step in ensuring the quality and safety of biopharmaceutical products. Custom assay development further enhances this process by delivering tailored solutions for specific needs. With ExCell Bio‘s expertise, companies can access precise, reliable, and regulatory-compliant analytical methods and assays, supporting the successful development and production of biopharmaceutical products.
