In the phase of antibody drug production, the modified antibody gene is introduced into an appropriate expression system (e.g., bacteria, yeast, mammalian cells, etc.) to enable the expression and production of large quantities of antibody protein. This usually involves steps such as construction of appropriate expression vectors, cell culture and fermentation, and protein purification. At the same time, in order to ensure the success of drug development and shorten the development cycle. The production process must focus on the analysis of the quality characterisation of the antibody drug and the accurate detection of nuclease residues.
Scale-up Production
Large-scale production of therapeutic antibodies in the CMC process involves cell culture, purification, formulation to ensure safe and effective therapies in sufficient quantities. In the production of the drug substance, cell culture techniques are typically employed for large-scale production of the target antibody using expression systems.
- Recombinant Antibody Services
Purification Process Development
In antibody drug production, nucleases are used to remove residual nucleic acids for optimal results and enhanced product safety. However, trace residues of nucleases can impact product application and may cause toxicity or immune reactions. Accurate detection of nuclease residues is crucial for ensuring product quality and safety.
- GENIUSTM Nuclease
- Nuclease Residue Detection Kit
Formulation Process Development
Due to the significantly larger molecular weight of antibody drugs compared to small molecule drugs and the potential for modification changes or particle aggregation during the manufacturing process, it is essential to perform quality characterization analysis at different stages of their lifecycle and production. This ensures successful drug development and shortens the development timeline.
- UNcle Quality Characterization Analytical Service