1.1 This practice assures stability of early phase products being introduced into the clinic. 1.2 The product characterization specified in this practice consistently assure that storage at less than or equal to -65C will provide one year stability of the new potential product. 1.3 This practice is applicable to mAb, IgG fusion, or other recombinant proteins produced from MCB cell lines (for example, CHO or murine hybridoma). 1.4 The one-year stability claimed by using this practice will be utilized initially but in conjunction with ongoing stability studies for the material held at various temperatures to explore degradation pathways of the development product. 1.5 Units--The values stated in SI units are to be regarded as the standard. No other units of measurement are included in this standard.
This standard would be useful to simplify the initial assessment of stability for an IND submission.
The title and scope are in draft form and are under development within this