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Related Experiment Video

Updated: Nov 14, 2025

Mass Spectrometric Approaches to Study Protein Structure and Interactions in Lyophilized Powders

Mass Spectrometric Approaches to Study Protein Structure and Interactions in Lyophilized Powders

Published on: April 14, 2015

Pharmaceutical protein solids: Drying technology, solid-state characterization and stability.

Yuan Chen¹, Tarun Tejasvi Mutukuri¹, Nathan E Wilson¹

¹Department of Industrial and Physical Pharmacy, College of Pharmacy, Purdue University, 575 Stadium Mall Drive, West Lafayette, IN 47907, USA.

Advanced Drug Delivery Reviews

|March 11, 2021

Summary

This summary is machine-generated.

Formulating unstable biologics requires solid-state approaches. This review covers drying techniques and characterization methods to ensure protein stability and product quality.

Keywords:

Drying technology Physical stability Process stress Protein solids Solid-state characterization

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Area of Science:

Pharmaceutical Science
Biotechnology
Materials Science

Background:

Biologics, particularly protein-based therapeutics, face inherent instability challenges.
Solid-state formulation is crucial for preserving protein structure and extending shelf-life, with nearly half of products utilizing this approach.
Drying processes introduce stresses that can compromise protein stability in solid forms.

Purpose of the Study:

To review traditional and emerging drying techniques for protein solid formulation.
To discuss the impact of drying-induced stresses on protein solid stability.
To highlight conventional and advanced characterization methods for assessing protein solid quality.

Main Methods:

Review of literature on drying techniques (e.g., lyophilization, spray drying).
Discussion of various stress factors during drying.
Analysis of characterization techniques: differential scanning calorimetry (DSC), solid-state Fourier transform infrared spectrometry (ssFTIR), solid-state fluorescence spectrometry, solid-state hydrogen deuterium exchange (ssHDX), solid-state nuclear magnetic resonance (ssNMR), and solid-state photolytic labeling (ssPL).

Main Results:

Drying techniques significantly influence the stability and quality of protein solids.
Characterization of protein solids is challenging due to limited reliable techniques.
Advanced methods offer higher resolution for investigating structural changes and molecular interactions.

Conclusions:

Developing robust solid-state formulations for biologics requires careful selection of drying techniques.
Enhanced understanding of stress impacts through advanced characterization is vital for improving protein product quality.
Continued innovation in drying and characterization will advance biologic formulation development.