title: Determining shelf life by comparing degradations at elevated temperatures.
abstract: The degradation of a biological product follows a specific pattern that depends on the kinetics of the chemical reaction. For most biological and pharmaceutical products, accelerated stability tests are preferred to establish shelf life. We describe a new approach for accelerated stability tests, for situations in which the Arrhenius equation is not appropriate. This approach consists of estimating stability at elevated temperatures and comparing these results with the stability estimates for a similar product with a known shelf life. In this article, "Test" refers to Immuno-Trol Low Cells, and "Control" (the product with a known shelf life) refers to Immuno-Trol Cells. The degradation rates and stabilities at elevated temperatures of three antigens of the Test are estimated and compared to their respective Control values. Most of the degradation occurs at the beginning of the experimental period and then slows down until it levels off to form a plateau at the minimum level. Both Control and Test showed similar degradation patterns at three elevated temperatures, indicating that they both have the same mechanism of degradation. Thus, it is expected that they will degrade similarly at storage temperature and have nonsignificantly different shelf lives. The approach for accelerated stability testing discussed here is applicable to situations in which the Arrhenius equation is not appropriate, and the chemical properties of both the Test and Control products are similar.
authors.affiliation: Beckman Coulter, Inc, Miami, Florida 33196-2500, USA. Robert.Magari@coulter.com
authors.forename: Robert T
authors.initials: RT
authors.lastname: Magari
authors.forename: Ileana
authors.initials: I
authors.lastname: Munoz-Antoni
authors.forename: Jennifer
authors.initials: J
authors.lastname: Baker
authors.forename: Daniel J
authors.initials: DJ
authors.lastname: Flagler
mesh_terms: D017252:CD3 Complex / Q000737:chemistry*; D016827:CD8 Antigens / Q000737:chemistry*; D004355:Drug Stability; D004356:Drug Storage / Q000592:standards*; D006801:Humans; D007700:Kinetics; D013696:Temperature; D013997:Time Factors
chemical_list: D017252:CD3 Complex; D016827:CD8 Antigens