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.

iFormulate

A unique formulation development platform developed by HTD Biosystems.
iFormulate 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 it 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.
iFormulate accelerates the development of biotech drugs. The iFormulate concept is based on an efficient high throughput algorithm that utilizes rational design of experiments and formulation parameters, to develop a pharmaceutically acceptable drug product.

Over the years we have helped our clients with the development of their protein drug candidate into stable drug products. We have developed high dose protein formulations and helped our clients overcome challenging formulation problems such as protein aggregation, and solubility problems.  Using the iFormulate platform, HTD Biosystems helps with rapid antibody screening and selection for the most stable formulations.
iFormulate was conceived for the purpose of providing the formulation scientist a predesigned formulation plate for assessing the stability of a protein drug using DOE (Design of Experiments) methodology. The basic plate consists of 20 unique formulations 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.
The iFormulate Advantage
  • Saves time, resources, and money without compromising on QUALITY.  Estimated savings of more than 70% compared to other alternatives. 
  • A minimum number of trials giving you the maximum amount of information!  
  • No need to make up the formulations.
  • Just need 1-5 mg protein.
  • No need to know DOE analysis, we do that for you and send you the results in a format that you can understand.
  • It provides a justification and rationale for your formulation selection.
The concept of iFormulate was developed at HTD Biosystems.  In formulating many proteins, an efficient high throughput algorithm was designed to perform preformulation of proteins in a rational fashion using Design of Experiments (DOE) and multivariate analysis.