20 Years of experience

Detailed analysis from low nm to mm range

Cutting-edge analytical techniques

As potential degradation products of all biopharmaceutical materials, particles can originate from diverse sources, including active pharmaceutical ingredients, formulation excipients, primary packaging components, and production processes. The presence of these particles holds the potential to impact therapeutic safety and efficacy profoundly. Two primary reasons to incorporate particle characterization into the drug development process: enhanced product quality control and comprehensive understanding of products, ingredients, and processes.

By measuring essential particle properties like size, shape, surface attributes, mechanical traits, charge properties, and microstructure, industries gain invaluable insights into material behavior and for reliable and accurate analysis of aggregation problems. The analysis should reveal whether the particles are intrinsic, extrinsic, or inherent, what size they are, and what material they are made of. This helps to identify the source of the problem in order to find an appropriate solution, whether your drug substance is in pre-clinical development or already in the commercial phase. Experience how Leukocare’s cutting-edge analytical techniques support you in the identification and interpretation of particle properties, from the low nm to the mm range, in the pursuit of enhanced patient safety and product development excellence.

Experts in Particle Characterization

Proper particle characterization is required for reliable and accurate analysis of aggregation problems. Leukocare's scientific expertise in particle characterization and cutting-edge technology allows for a proper root-cause analysis of aggregation issues. Our comprehensive range of analytical techniques, including Raman spectroscopy, SVP-LO, Dynamic Light Scattering (DLS), and SEC-UV-RI-(MALS), allows us to dive deep into particle dimensions, structures, and chemical compositions. We can also provide you with a comprehensive analysis of infectious and/or genetically modified vaccines, as well as viral vectors that require an S2/BSL-2 compliant area.

Supporting your Aggregation Root Cause Analysis

Particle characterization – essential particle attributes

  • Size, size distribution
  • Shape
  • Sub-visual particle imaging
  • Quantity
  • Aggregates
  • Concentration
  • Chemical properties

Analytical Methods for Particle Characterization

  • Low nm
  • Quantification and size distribution of fragments and aggregates
Dynamic Light Scattering (DLS)
  • 5 nm - 1000nm
  • Size determination
  • Size distribution
Microflow Imaging
  • 2 um - 1000 um
  • Size determination
  • Shape determination
  • Distribution
  • Quantification
  • Categorization via visual AI
Microscopy/Raman Laser-induced Breakdown Spectroscopy
  • um range
  • Particle characterization 
  • Identification
  • nm - mm
  • Quantitative turbidity assessment 
  • Colloidal properties
Visual Inspection / Appearance
  • greater than 0,1 mm
  • Description
  • Quantification
Nanoparticle Tracking Analysis (NTA)
  • 10 - 1000 nm range
  • Size determination
  • Shape determination