iGORi is member of the California Biotech Research Consortium, founded by former Amgen scientists. We are located in the Thousand Oaks area in Southern California, about 40 miles north from the Los Angeles airport (LAX). The Consortium can provide full-scale biotechnology and pharmaceutical product development services. iGORi is a unique organization, that focuses on research to identify and eliminate pharmaceutical and biopharmaceutical drug development related scientific problems, and providing assistance with complex problem solving and product understanding. Our experience in analytical chemistry, separation sciences, macromolecular characterization methods, organic and polymer chemistry and protein biochemistry, when combined with the proper instrumentation, enables us to solve complicated drug analysis, drug formulation and drug stability related challenges.
Pharmaceutical and biopharmaceutical product development is an inherently complex process.Each stage of the drug development process uses a series of analytical methods, which are developed for the specific needs of that particular development stage. At each consecutive stage, the use of previously developed analytical methods is encouraged. This method transfer concept has two major objectives: (1) saving method development resources; and (2) providing experimental data that are comparable with previous results.However the objectives at progressing development stages are different:
At the early research stage purification and identification of the drug substance are the primary goals.
For toxicology and drug metabolism studies the purification and identification of the parent compound and its metabolites are needed.
At the formulation stage the primary concern is stability of the drug substance.
Dissolution studies measure the kinetics of the appearance of the drug substance from specific formulations.
Final drug product release assays are for drug substance identification and quantitative analysis for consistency and efficacy.
The common element in all of these analytical methods is the presence of the drug substance.It seems logical to use the analytical methods developed during early research across the whole drug development process.In some cases this concept can work.However, in most cases analytical methods are not applicable through the whole drug development pathway.Each drug development stage has a different sample environment, different sensitivity requirements, and a different impurity profile.
The sample environment affects sample preparations. The sample matrix can induce degradation of the drug substance.
Derivatization, adsorption and physical encapsulation of drug substance by the formulation polymers may occur.
Protein and peptide based pharmaceuticals are known to be sensitive to their conformational state.Alteration of the three dimensional structure, aggregation and hydrolysis are frequently observed.
Understanding how these factor influences the analysis, and finding solutions that reliably obtain the required information in the face of these complexities, is a challenge that requires broad experience in analytical and organic chemistry, biochemistry and polymer chemistry. The scientists at iGORi have a proven track record of meeting this challenge.
iGORi specializes in pharmaceutical and biopharmaceutical preformulation and formulation related issues: