Simplify the complexity of impurity profiling
Your biologic must be eventually free of host cell proteins, nucleic acids and process related impurities for the safety of the final drug product. Therefore, an understanding of the potential impurities and the acceptable limits must be established.
Bacterial or fungal burdens need to be determined per USP/EP guidelines through microbial testing, whist viruses are detected with several in vitro and in vivo assays. In addition, for viral vector development such as Adeno-Associated Virus (AAV), viral capsid characterization is assessed for varying degrees of encapsidation – empty, partial, and full genome capsids.
We offer innovative solutions from nucleic acid analysis, protein characterization to AAV characterization, all designed to help streamline impurity profile workflows and maintain GMP compliance in drug discovery and development.
For research use only. Not for use in diagnostic procedures.
