1. What does an iFormulate plate look like ? A 96-well plate with 2 sets of Formulations (two 5 X 5 wells)
pH indicator is added to each well to show the formulations at different pHs. Layout is 2 sets the formulations arranged as 5 X 5 wells.
2. How many formulations are being tested ? 20 unique formulations plus 5 replicates. 25 Total + any controls you may want to add in the empty wells.
3. Why the 5 replicates ? To make sure that the data is statistically valid, We don’t want Garbage In/Garbage Out (GI/GO).
4. What do I need ? You need to have 3 things. (1)Your protein at an appropriate concentration (typically 5 X) as you will be diluting it 5-fold in the formulation. Typically, 5-10 mg/ml protein is sufficient. Need 1 ml of protein (40 ul/well X 25 wells). (2) Know what stress conditions are required to destabilize your protein, and (3) the appropriate stability-indicating assay to analyze the formulations.
5. What volumes am I dealing with? 200 uL final volume per formulation well.
6, What does a typical procedure look like ? Go to iFormulate Protocol page.
7. How long does it take to do a pre-formulation study ? Depends on your design. We have formulated a protein in an afternoon using protein aggregation as a stability-indicating assay with as little as 10 mg of protein.
8. How much time and resources do I save ? This is a great question! It depends on the resources for your assay. All the formulations have already been made up and the design is specifically made to perform the minimum number of experimental trials generating the maximum amount of information to make a rational formulation decision.
Our estimate is that you can save at least 80 % in time and resources using the iFormulate approach.
9. Who does the analysis ? We can do it for you as part of the iFormulate service. You email us the data in excel format and we perform the DOE analysis. There are no proprietary issues with your protein as that information is not required for the analysis.
10. What do the DOE analysis look like ? You get a DOE analysis report on Pareto analysis (ranking of key variables), optimal pH, ionic strength, stabilizer concentration, and buffer concentration. Please see the poster on iFormulate presented at the AAPS National Biotech. iFormulate poster-AAPSNBC-2011
11. Can I have an iFormulate plate custom designed to my specific needs ? Of course, please contact us to discuss your specific needs.