Lack of satisfactory testing for Extractables/Leachables has been identified as a common problem in Biologics CMCs. Leachables however feature prominently as possible causes for Biologics Quality parameters such as Particulates and Immunogenicity. Extractables/Leachables include non-volatiles, semi-volatiles, volatiles, and trace metals. Non-volatiles E/L chemicals can be tested by HPLC-MS whereas volatiles would need to be tested by GC-MS. Trace metal residues require Atomic Spectroscopy.
Methods of the appropriate sensitivity and specificity must be chosen in order to reach meaningful conclusions for the E/L study. In this Webinar the sensitivity and specificity of some commonly used methods and some promising emerging tools will be presented. This webinar provides the needed information to implement an effective testing program for Extractables/Leachables in Biologics.
Methods of the appropriate sensitivity and specificity must be chosen in order to reach meaningful conclusions for the E/L study. In this Webinar the sensitivity and specificity of some commonly used methods and some promising emerging tools will be presented. This webinar provides the needed information to implement an effective testing program for Extractables/Leachables in Biologics.
