Skip to the main content.
Facebook Linkedin X

MotM Email Header (1)

Reduce Risk in Drug Development  

Learn how Charge Variant Analysis enables drug developers to meet regulatory expectations, avoid costly mistakes, and ensure product quality throughout the biologics lifecycle directly from one of KBI Biopharma’s leading scientific experts. 

Get the Full Video and Guide

Why Charge Variant Characterization Matters 

Charge variants in your biologic drug product can have serious implications. Deamidation, oxidation, and different glycan species can affect product quality, patient safety, and impact regulatory approval. 

Patient Safety Risk

Missing potentially immunogenic species that could harm patients

Regulatory Delays

BLA approval delayed or rejected due to
incomplete characterization data 

Manufacturing Failures

Scale-up issues when variants impact product quality and consistency 

Quality
Control

Compromised product consistency without adequate CQA monitoring 

What You’ll Learn: 

  • What charge variant characterization is and how fractionation studies combined with mass spectrometry reveal product variants at the molecular level

  • When to conduct these studies throughout your drug development lifecycle from Phase 1 method development through BLA submission

  • Real world success story: How charge variant characterization enabled biosimilar approval by proving charge differences had no effect on potency

  • Common implementation mistakes including why icIEF platforms often fail and how HPLC methods enable full characterization including bioactivity 

Access Both Formats Today! 

Fill out the form above to get instant access to both the full video interview and the interactive guide with Kelly Donovan, Director of Characterization Services at KBI Biopharma. 

Full Video Interview

25-minute comprehensive conversation 
  • Complete interview with Kelly Donovan
  • Real world-case studies and examples
  • Q&A addressing key questions

Interactive Guide 

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

GET THE VIDEO AND GUIDE

Kelly Donovan

MEET YOUR EXPERT: Kelly Donovan

Director of Characterization Services
KBI Biopharma

Kelly Donovan leads a team of scientists specializing in biochemical separations, mass spectrometry, and biological characterization. With over 20 years of experience in biotherapeutic product characterization, Kelly's expertise centers on the Elucidation of Structure section of the Marketing Application, a critical component of regulatory submissions. 

Her leadership ensures that complex characterization data are translated into regulatory-ready documentation that supports client commercialization timelines. Kelly has guided numerous biosimilar and novel biologic programs through successful IND and BLA submissions. 

LinkedIn Icon

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.