iFormulate™, high throughput formulation development
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.
iFormulate™ is a family of products for various applications in drug development
iFormulate RS-1
25 Response Surface DOE formulations that optimize:
pH (5.0 - 8.0)
Ionic Strength
Buffer Concentration
Stabilizer Concentration
iFormulate RS-2
25 Response Surface DOE formulations that optimize:
pH (5.0 - 7.6)
Ionic Strength
Buffer Concentration
Stabilizer Concentration
iFormulate RS-3
25 Response Surface DOE formulations that optimize:
pH (5.0 - 7.6)
Ionic Strength
Buffer Concentration
Stabilizer Concentration (Sucrose)
HTD Biosystems has expertise in protein formulation development, lyophilization, solid-state structure, and liposomal drug delivery systems, and is the right partner for the development of your next smart delivery system for delivering antibodies, immunotherapy medicines, anti-cancer drugs, antigens, vaccines, DNA and Proteins. We have extensive experience from pH-sensitive liposomes, PEGylated liposomes, remote loaded liposomes and other forms of nano-particulate systems both as liquid and as freeze-dried products. Concepts developed at our company have been licensed to companies such as Pfizer by our clients.
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.
