Lyophilized protein powders: A review of analytical tools for root cause analysis of lot-to-lot variability

Research output: Contribution to journalArticleResearchpeer-review

Abstract

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.
Original languageEnglish
Pages (from-to)468-491
JournalTrends in Analytical Chemistry
Publication statusPublished - Sep 2016

Fingerprint

powders
freeze drying
proteins
biopharmaceuticals
process control
product quality
analytical methods
physical properties
physicochemical properties
drugs

Cite this

Lyophilized protein powders: A review of analytical tools for root cause analysis of lot-to-lot variability. / Paudel, Amrit; Wahl, Verena; Khinast, Johannes.

In: Trends in Analytical Chemistry, 09.2016, p. 468-491.

Research output: Contribution to journalArticleResearchpeer-review

@article{57564eb6105d4fc2969a39d11d728529,
title = "Lyophilized protein powders: A review of analytical tools for root cause analysis of lot-to-lot variability",
abstract = "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.",
author = "Amrit Paudel and Verena Wahl and Johannes Khinast",
year = "2016",
month = "9",
language = "English",
pages = "468--491",
journal = "Trends in Analytical Chemistry",
issn = "0165-9936",
publisher = "Elsevier B.V.",

}

TY - JOUR

T1 - Lyophilized protein powders: A review of analytical tools for root cause analysis of lot-to-lot variability

AU - Paudel, Amrit

AU - Wahl, Verena

AU - Khinast, Johannes

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.

M3 - Article

SP - 468

EP - 491

JO - Trends in Analytical Chemistry

JF - Trends in Analytical Chemistry

SN - 0165-9936

ER -