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Mass Photometry and AUC with Nikki Combs (1)

Reduce Risk in Drug Development  

Learn how mass photometry and analytical ultracentrifugation work together to protect product quality, accelerate candidate screening, and support regulatory readiness for gene therapies and biologics. Practical insights from Nikki (Machalek) Combs, Senior Scientist at KBI Biopharma, specializing in biophysical characterization and AAV size distribution analysis. 

Get the Full Video and Guide

Mass Photometry and AUC Matter   

For gene therapies and biologics, understanding your product's size distribution is a critical quality attribute that regulatory agencies scrutinize closely. Without the right analytical tools at the right time, development teams face preventable setbacks. 

Reduced Efficacy

Empty or partially filled capsids or hidden aggregates that dilute effective dose 

Slow Decision Cycles

Relying solely on AUC during early screening, slows candidate selection and process development

Regulatory Risk

Insufficient characterization of capsid fill states leading to questions at filing

Expensive Batch Failures

Inconsistencies between upstream production and downstream purification 

What You’ll Learn: 

  • What mass photometry is and how it measures the mass of individual molecules in solution without labels or chemical modification
  • When to use mass photometry versus AUC throughout the development lifecycle
  • Industry case study: How mass photometry detected hidden partially filled capsids that electron microscopy and AUC missed
  • Common implementation mistakes including sample preparation errors and the misconception that mass photometry can replace all orthogonal techniques
  • KBI's recommended approach: mass photometry paired with AUC for a powerful, complementary characterization package

Access Both Formats Today! 

Fill out the form above to get instant access to both the full video interview and the comprehensive guide with Nikki (Machalek) Combs, Senior Scientist at KBI Biopharma.

Full Video Interview

25-minute comprehensive conversation
  • Complete interview with Nikki (Machalek) Combs
  • Real-world case studies and examples
  • In-depth discussion of mass photometry, AUC, and AAV characterization 

Interactive Guide 

Comprehensive guide with video clips 
  • Complete written resource
  • Key video clips embedded throughout
  • Easy to reference and share

GET THE VIDEO AND GUIDE

Nikki Machalek

MEET YOUR EXPERT: Nikki (Machalek) Combs

Senior Scientist
KBI Biopharma, Louisville, Colorado

Nikki earned her degree in Chemical and Biological Engineering from the University of Colorado at Boulder and has been at KBI Biopharma for nine years. She leads biophysical characterization efforts with a focus on gene therapies, specializing in analyzing adeno-associated virus size distributions using mass photometry and analytical ultracentrifugation. Nikki has extensive experience with higher order structure techniques and works across multiple modalities including AAVs, mRNA, and lipid nanoparticles. Her expertise enables clients to make faster, more informed decisions during candidate screening, process development, and regulatory preparation.

Flexible, Knowledgeable, and Proven


About KBI Biopharma

KBI Biopharma is a leading global contract development and manufacturing organization (CDMO) providing fully integrated, accelerated drug development and biologics manufacturing services and expertise to life science companies. With each of our 1400+ customer partners, we work closely to personalize and accelerate drug development programs. Built upon a foundation of world-class analytics capabilities and extensive scientific and technical expertise, we deliver robust process development and clinical and commercial cGMP manufacturing services for mammalian and microbial. Recognized for quality manufacturing, we help clients advance drug candidates into the clinic and beyond. 

Science Driven. Customer Focused.