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IMG_2261HTD Biosystems offers an exciting product for formulation development called the iFormulate plate.

 

iFormulate is a plate pre-loaded with formulations designed by DOE for rational formulation development.

It evaluates the 4 major variables of any protein formulation; pH, ionic strength, buffer and stabilizer concentration using multivariate experimental design.

The process goes like this:  ADD your protein to the formulations, STRESS the formulations in the iFormulate plate to partially destabilize the protein, and COLLECT the data from each formulation using stability-indicating assay(s).

Email the data to data@iFormulate.net and receive a DOE analysis report on Pareto analysis (ranking of key variables), optimal pH, ionic strength, stabilizer and buffer concentration for your protein.

The iFormulate Advantage

  1. Saves time, resources, and money without compromising on QUALITY.  Estimated savings of more than 70%
  2. Minimum number of trials giving you the maximum amount of information! 
  3. No need to make up the formulations.
  4. Just need 1-5 mg protein.
  5. No need to know DOE analysis, we do that for you and send you the results in a format that you can understand.
  6. Provides a justification and rationale for your formulation selection.

iFormulate Principle

iFormulate was conceived for the purpose of providing the formulation scientist a pre-designed formulation plate for assessing the stability of a protein drug using DOE (Design of Experiments) methodology.  The basic plate consists of 20 unique formulation and 5 replicate formulations (for statistical data verification).  The formulations are placed randomly to remove any bias.  The DOE  is a response-surface multivariate design that evaluates the effect of pH, ionic strength, buffer and stabilizer concentration on the protein of interest.

What is iFormulate ?

It is a pre-designed formulation plate loaded with unique formulations to evaluate the importance of key formulation variables, such as pH, ionic strength, buffer concentration, and stabilizer concentration.  Use of the iFormulate plate does not require any training in DOE methodology or statistics BUT does require you to know how to analyze your protein and what is/are the crucial stability-indicating assays.  It also saves you time in preparation of 20 unique formulations as these have already been prepared for you.

The use of the iFormulate process requires adding your protein to the various formulations (25 total wells in a 96-well plate), stressing your protein to destabilize it or aggregate it a bit, and analyzing the 25 formulations using your stability-indicating assay(s).

Send us your results and we will analyze your data and send you a report on what are the key variables for a stable formulation.