Using X-Ray Crystallography to Simplify and Accelerate Biologics Drug Development

Area of Science:

• Biophysics
• Structural Biology
• Drug Discovery

Background:

• Major biopharmaceutical companies utilize protein crystallography for drug discovery.
• Higher order structural characterization is crucial but challenging in biologics manufacturing.
• X-ray crystallography is underutilized in drug development despite its potential.

Purpose of the Study:

• To examine myths surrounding protein crystallography.
• To highlight the practical applications of protein crystallography in biologics manufacturing.
• To advocate for the broader adoption of protein crystallography in drug development.

Main Methods:

• Review of current industry practices and perceptions of protein crystallography.
• Analysis of inherent properties of protein crystals.
• Comparison of protein crystal properties with requirements for liquid drug products.

Main Results:

• Protein crystallography is often overlooked for biologics manufacturing due to outdated thinking.
• Protein crystals possess properties like molecular identity, purity, and uniformity.
• These properties align with the needs of patient-focused liquid drug products.

Conclusions:

• Protein crystallography can be a routine analytical test for biologics.
• Its application can lead to the identification of superior drug candidates.
• This can streamline high-concentration processing, formulation, and analysis, reducing development time and cost.