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Whitepaper

Beyond Particle Counting: Why Modern Biologics Need Particle Forensics

Stop Counting Particles. Start Solving the Mystery.


In the development of modern biologics, a high particle count is a warning sign—but it’s rarely the whole story. While standard labs focus on how many particles are in your formulation, KBI Biopharma specializes in Particle Forensics: identifying what they are, where they originated, and how to mitigate the risk to your program.

Download our latest whitepaper, Beyond Particle Counting: Why Modern Biologics Need Particle Forensics, to see how our proprietary technology and expert interpretation turn raw data into a decisive roadmap for success.

Inside the Whitepaper: Moving Beyond the Data

  • The Limits of Traditional MFI: Understand why standard particle counting often leads to false alarms and "ghost" stability issues that can derail timelines.
  • The Power of PICTS: Discover our proprietary Particle Image Classification Tool Suite, the machine-learning platform built by KBI to identify particles with a depth of context no other lab can match.
  • Expert Interpretation: Why data is only as good as the scientists behind it. Learn how our team analyzes results within the specific context of your formulation and process.
  • A Particle Mystery Solved: A deep dive into how KBI identified a root cause in just days—distinguishing benign silicone oil from dangerous protein aggregates to save a client’s low-dose program.

The KBI Advantage

We don't just hand you a report; we provide the forensic evidence required to protect your drug product. By turning raw MFI data into actionable insights, we help you reduce risk and move your program forward with total confidence.

Don’t let your data leave you guessing.

Standard counting shows the problem. KBI’s forensics reveal the solution.

Download the Whitepaper Now

Downloading the Whitepaper Also Includes Access to:

Case Study

MotM Email Header (2)Kylee Harris, Scientist II in Rapid Analyticsat KBI, presents a real-world case study on how KBI’s proprietary Particle Image Classification Tool Suite (PICTS) identifies silicone oil contamination missed by standard testing methods. 

Expert Interview

Greg Chrimes InterviewGreg Chrimes, Vice President of Analytical and Formulation Sciences and Site Head, explains how traditional counting misses critical protein aggregates. KBI Biopharma uses particle forensics and Micro-Flow Imaging (MFI) to identify these particles, ensuring drug safety and efficacy. This "beyond the count" approach helps developers mitigate risks and streamline the path to clinical success.

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+ client 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 programs. Recognized for quality manufacturing, we help clients advance drug candidates into the clinic and beyond. 

Science Driven. Customer Focused.