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Reduce Risk in Drug Development  

Learn how clinical in-use studies protect patient safety, prevent costly clinical delays, and ensure your drug product reaches patients safely directly from one of KBI Biopharma's leading particle characterization experts.

Get the Full Video and Guide

Why Clinical In-Use Studies Matter  

Clinical in-use studies are the final safety checkpoint before your drug product reaches patients. Without comprehensive compatibility testing administration of biologics (i.e., IV bags, syringes, and medical devices) can compromise product quality, patient safety, and clinical timelines.  

Patient Safety Risk

Missing particle formation or contamination that could harm patients during administration

Clinical
Delays

Discovering compatibility problems at clinical sites causing costly reformulation and timeline delays

Costly Repeat Testing

Under-scoped studies requiring additional testing when expanding to new clinical sites or patient populations 

Formulation Failures

Late-stage discovery of issues near IND filing when reformulation costs are exponentially higher 

What You’ll Learn: 

  • What clinical in-use studies are and how they test every step from final packaging to patient administration with real-world handling stresses

  • When to conduct these studies (i.e., required before IND filing) and why early testing prevents costly late-stage changes

  •  A Real-world case study on how KBI's proprietary Particle Image Classification Tool Suite (PICTS) tool identified silicone oil contamination from syringe-and-needle extraction that standard methods missed

  • Common implementation mistakes including improper scoping (i.e., over or under-testing) and why real-time testing with particle identification is critical

  • KBI's two-phase approach including broad screening followed by focused testing that eliminates variables efficiently without inflating costs

Access Both Formats Today! 

Fill out the form above to get instant access to both the full video interview and the comprehensive guide with Kylee Harris, Senior Scientist, in Critical Quality Attributes at KBI Biopharma.

Full Video Interview

30-minute comprehensive conversation 
  • Complete interview with Kylee Harris
  • Real-world case studies and examples
  • In-depth discussion of PICTS capabilities and study design strategies

Interactive Guide 

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

GET THE VIDEO AND GUIDE

Kylee Harris Headshots

MEET YOUR EXPERT: Kylee Harris

Scientist II in Rapid Analytics
KBI Biopharma

Kylee Harris earned her degree in Chemical and Biological Engineering from Colorado State University and has been at KBI since 2022. She specializes in the design, execution, and interpretation of clinical in-use studies, with particular expertise in particle characterization for drug product development and IV bag and device compatibility testing. Kylee works extensively with advanced particle identification tools including Micro-Flow Imaging (MFI) with PICTS (Particle Image Classification Tool Suite) and forensic analysis techniques to troubleshoot complex compatibility challenges across gene therapies, ADCs, and protein therapeutics.

Kylee is passionate about clinical in-use studies as a critical step in drug product development to help ensure patient safety and clinical efficacy. She brings a comprehensive understanding of both the scientific and practical aspects of ensuring drug products reach patients safely.


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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.