Particle Characterization for Biologics & ATMPs
Overview
Milestone Pharma provides particle characterization for biologics and advanced therapy medicinal products (ATMPs), delivering fit-for-purpose data to support formulation development, stability and comparability, and CMC submissions.
We design orthogonal analytical strategies across size, morphology, concentration, composition, and aggregation to help you define, monitor, and control critical quality attributes (CQAs) throughout the product lifecycle.
Services
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Method Development
We provide fit-for-purpose particle characterization for biologics and ATMPs, combining orthogonal methods to generate decision-ready data for development, comparability, stability, and release support.
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Size & Distribution Analysis
Characterize particle size, size distribution, and heterogeneity using complementary techniques suited to the expected size range and sample matrix.
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Particle Concentration & Counting
Measure particle concentration and count distributions to support formulation assessment, batch comparison, and trend monitoring.
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Morphology & Integrity Assessment
Visualize particle morphology and evaluate structural integrity to confirm particle identity and investigate changes during development or storage.
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Composition & Identity Profiling
Generate compositional and identity evidence for complex modalities, including support for impurity profiling and formulation understanding.
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Subpopulation & Empty/Full Characterization
Resolve heterogeneous particle populations and, where applicable, assess attributes such as empty/full ratios for viral vector systems.
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Aggregation, Particles & Stability Support
Investigate aggregation and particulate risks across nano-to-micron ranges and generate supportive evidence for higher-order structure and thermal stability.
Each study is designed around your product type, intended use, and target CQAs, with orthogonal method selection and reporting aligned to your project goals.
Applicable Drug Products
Milestone pharma supports particle characterization for a wide range of biologic drug products. Equipped with advanced analytical platforms, we tailor each study to your specific drug product.
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Lipid nanoparticles (LNPs) and liposomes
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Polymeric nanoparticles
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Extracellular vesicles (EVs)/exosomes
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Virus-like particles (VLPs) and vaccines
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Viral vectors (e.g., AAV)
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Protein therapeutics (incl. antibodies)
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Oligonucleotides and nucleic acids
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Gene and cell therapy drug products
Feature Strengths
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Orthogonal, fit-for-purpose study design
Orthogonal confirmation for key CQAs
Fit-for-purpose methods by intended use
Study plan, report, and raw data deliverables
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Lifecycle support for complex modalities
Development: CQA understanding package
Stability: trending and root-cause investigations
Comparability: orthogonal panel and reporting
FAQ
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What do you deliver at the end of a project?
Deliverables typically include a fit-for-purpose study plan, a technical report with results and interpretation, and raw data exports where applicable. Qualification or validation summaries can also be provided within the agreed scope.
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What if different methods give different results?
Differences can result from sample heterogeneity, matrix effects, or the measurement principles of each method. We review preparation, working range, and orthogonal evidence to provide a consistent interpretation and practical next steps.
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What information do you need to start a study?
We usually need the product modality, concentration range, formulation or buffer details, and intended use such as development, comparability, stability, or release support. If target CQAs or specifications are available, we align the study plan accordingly.
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How do you choose methods for size and concentration?
We select methods based on particle type, expected size range, polydispersity, and matrix effects. A typical study may combine screening, separation-based, particle-by-particle, and imaging methods to build a reliable interpretation.
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Why is orthogonal particle characterization important?
Because no single method can fully describe complex particles across all sizes, structures, and sample matrices. Orthogonal methods strengthen confidence in key CQAs such as size distribution, concentration, morphology, and aggregation.
Discuss My Project
Speak with an expert about your upcoming project to see how we can help you.