TY - JOUR
T1 - Lyophilized protein powders: A review of analytical tools for root cause analysis of lot-to-lot variability
AU - Wahl, Verena
AU - Khinast, Johannes
AU - Paudel, Amrit
PY - 2016/9
Y1 - 2016/9
N2 - Lyophilization of proteins can introduce lot-to-lot variabilities in different product properties that are crucial in terms of product performance and stability. As these variations can raise several issues related to product quality, the characterization of the physical and chemical properties of protein lots is necessary, to identify critical deviations between the lots and to rationally control the process to yield an acceptable product. The critical concerns are potential quality issues of the drug product and (negative) effects on the reconstitution behavior of the solid-state lyophilized proteins. This review provides an overview of powder properties and physicochemical attributes of solid protein formulations manufactured by lyophilization that are potentially associated with lot-to-lot variabilities. Brief descriptions of various conventional, as well as novel, analytical techniques, which are suitable for characterizing the properties of the pharmaceutical protein powder, are discussed.
AB - Lyophilization of proteins can introduce lot-to-lot variabilities in different product properties that are crucial in terms of product performance and stability. As these variations can raise several issues related to product quality, the characterization of the physical and chemical properties of protein lots is necessary, to identify critical deviations between the lots and to rationally control the process to yield an acceptable product. The critical concerns are potential quality issues of the drug product and (negative) effects on the reconstitution behavior of the solid-state lyophilized proteins. This review provides an overview of powder properties and physicochemical attributes of solid protein formulations manufactured by lyophilization that are potentially associated with lot-to-lot variabilities. Brief descriptions of various conventional, as well as novel, analytical techniques, which are suitable for characterizing the properties of the pharmaceutical protein powder, are discussed.
U2 - 10.1016/j.trac.2016.05.012
DO - 10.1016/j.trac.2016.05.012
M3 - Article
VL - 82
SP - 468
EP - 491
JO - Trends in Analytical Chemistry
JF - Trends in Analytical Chemistry
ER -