Method of the Month
Expert Insights. De-risking Development. One Method at a Time.
Coming Soon: May 2026
Peptide Mapping
With Ben Ziegterman
Learn how peptide mapping by mass spectrometry reduces risk, prevents costly late-stage failures, and keeps your biologics program on track. Practical insights from Ben Zigterman, a 14-year protein characterization expert and Senior Scientist at KBI Biopharma.
Topics covered:
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Defining specific use cases to ensure effective study design
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Meeting regulatory requirements and diagnosing unexpected assay signals
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A case study focusing on identifying unexpected mAb variant that cIEF, SEC, and standard peptide mapping couldn't explain
Latest Episode: April 2026
Analytical Control Studies
With Brent Kendrick, PhD
Learn how a strong analytical control strategy reduces risk, prevents costly late-stage failures, and keeps your biologics program on track. Practical insights from Brent Kendrick, PhD, a 30-year biologics development veteran and former VP of R&D at KBI Biopharma.
Topics covered:
- What a strong analytical control strategy actually requires
- Three reasons a strong strategy prevents failures and reduces risks
- Two real-world case studies with hard lessons
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February 2026
Clinical In-Use Studies
With Kylee Harris
Demonstrating product stability during clinical use is essential for regulatory approval and commercial success. Learn how to design robust studies that support your label claims and meet FDA/EMA expectations.
Topics covered:
- Study design fundamentals for in-use stability testing
- Meeting regulatory expectations for storage and handling claims
- Container closure system considerations
- Common protocol design mistakes that invalidate results
- Data interpretation and specification setting
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January 2026
Charge Variant Characterization
With Kelly Donovan, Director of Characterization Services
Charge variant characterization is a regulatory expectation for understanding product heterogeneity and ensuring patient safety. Without proper characterization, you risk missing immunogenic species, delaying BLA approval, or compromising product quality.
Topics Covered:
- What charge variant characterization is and how fractionation studies reveal product variants
- When to conduct studies from Phase 1 through BLA submission
- Why icIEF platforms often fail and how HPLC methods enable full characterization
- Real biosimilar case study: Proving charge differences had no effect on potency
- Common implementation mistakes that delay regulatory submissions
Kelly Donovan leads KBI's characterization services team with over 20 years of experience in biotherapeutic product characterization. Her expertise in the Elucidation of Structure section has guided numerous programs through successful IND and BLA submissions. 
Built on Proven Analytical Excellence
Method of the Month brings you insights from KBI Biopharma's team of analytical experts, backed by:
Our analytical scientists don't just generate data. They apply expertise to solve problems, guide programs through regulatory requirements, troubleshoot unexpected challenges, and collaborate across teams to find the right solution for your molecule.
Each Method of the Month Includes:
Expert Video Series
5 focused segments (45-90 seconds each) plus one long-form interview covering what, why, when, and how
Comprehensive Guide
Technical details, implementation strategies, and regulatory considerations
Real Case Studies
Examples from actual client programs showing impact and outcomes
Best Practices
Common mistakes to avoid and tips for successful implementation
About Your Host:
Marissa Jones, PhD, Product Manager
With a PhD in analytical chemistry and commercial experience in biopharma, Marissa translates complex methods into actionable guidance. Each month, she sits down with a KBI analytical expert to break down one critical method that derisks biopharmaceutical development.
Need Analytical Support Now?
Realizing your current analytical approach has gaps? Facing a submission deadline and need expert guidance? Whether you're missing critical characterization data, need method development support, or want to ensure your CMC package is regulatory-ready, our team can help.
We provide comprehensive characterization services, method development, and regulatory filing support from early-phase through commercial manufacturing.
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