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Particle Characterization
Particle Characterization
Case Study: Overcoming Particle Formation in Monoclonal Antibody (mAb) Development
Case Study: Overcoming Particle Formation in Monoclonal Antibody (mAb) Development
Particle Characterization for Safer Biologics
Particle Characterization for Safer Biologics
As potential components of all biopharmaceutical samples, particles can originate from various sources, including active pharmaceutical ingredients (APIs), formulation excipients, and manufacturing processes. The presence of these particles holds the potential to impact therapeutic safety and efficacy profoundly. Two primary reasons industries incorporate particle characterization into the drug development process: enhanced product quality control and gain a 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 preclinical development or already in the commercial phase.
Discover how Leukocare’s advanced analytical techniques support the identification and characterization of particles — ranging from the sub-nanometer to the millimeter scale — contributing to improved patient safety and excellence in product development.
As potential components of all biopharmaceutical samples, particles can originate from various sources, including active pharmaceutical ingredients (APIs), formulation excipients, and manufacturing processes. The presence of these particles holds the potential to impact therapeutic safety and efficacy profoundly. Two primary reasons industries incorporate particle characterization into the drug development process: enhanced product quality control and gain a 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 preclinical development or already in the commercial phase. Discover how Leukocare’s advanced analytical techniques support the identification and characterization of particles — ranging from the sub-nanometer to the millimeter scale — contributing to improved patient safety and excellence in product development.
As potential components of all biopharmaceutical samples, particles can originate from various sources, including active pharmaceutical ingredients (APIs), formulation excipients, and manufacturing processes. The presence of these particles holds the potential to impact therapeutic safety and efficacy profoundly. Two primary reasons industries incorporate particle characterization into the drug development process: enhanced product quality control and gain a 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 preclinical development or already in the commercial phase. Discover how Leukocare’s advanced analytical techniques support the identification and characterization of particles — ranging from the sub-nanometer to the millimeter scale — contributing to improved patient safety and excellence in product development.
Hear from our experts
Connect with Our Team to Improve Product Safety and Stability
Ulrike Konrad, VP Business Development
Hear from our experts
Connect with Our Team to Improve Product Safety and Stability
Ulrike Konrad, VP Business Development
Hear from our experts
Connect with Our Team to Improve Product Safety and Stability
Ulrike Konrad, VP Business Development
Experts in Particle Characterization
Supporting your aggregation root cause analysis
Essential Particle Attributes
Analytical Methods for Particle Characterization
Our Offerings
Proper particle characterization is required for reliable and accurate analysis of aggregation problems.
Leukocare's scientific expertise in particle characterization, its wide range of analytical techniques, and our data-science approach is the ideal combination for a proper root-cause analysis of aggregation issues.
From techniques like scanning electron microscopy (SEM) for understanding particle dimensions and structure, as well as Raman spectroscopy for chemical composition analysis, Leukocare’s team of scientists is here to help you determine the source of your drug product aggregation. We can provide you with a comprehensive analysis of infectious and/or genetically modified vaccines, as well as viral vectors that require an S2/BSL-2 area. Our S2/BSL-2 services encompass microscopy and Raman laser-induced breakdown spectroscopy for an in-depth examination.
Our approach provides a consolidated readout that is practical,
actionable and designed to accelerate decision-making.
Instead of generic risk notes, you receive outputs that can directly inform
experimental design, development priorities and clinical planning:
Proper particle characterization is required for reliable and accurate analysis of aggregation problems.
Leukocare's scientific expertise in particle characterization, its wide range of analytical techniques, and our data-science approach is the ideal combination for a proper root-cause analysis of aggregation issues.
From techniques like scanning electron microscopy (SEM) for understanding particle dimensions and structure, as well as Raman spectroscopy for chemical composition analysis, Leukocare’s team of scientists is here to help you determine the source of your drug product aggregation. We can provide you with a comprehensive analysis of infectious and/or genetically modified vaccines, as well as viral vectors that require an S2/BSL-2 area. Our S2/BSL-2 services encompass microscopy and Raman laser-induced breakdown spectroscopy for an in-depth examination.
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Blog Article
Case Study
Overcoming Particle Formation in Monoclonal Antibody Development
A leading biopharmaceutical company faced a major challenge: their monoclonal antibody (mAb)
was forming unwanted particles, threatening its clinical development.
Leukocare stepped in to identify the root cause and develop a formulation that ensured long-term stability.
Case study
Step 1: Particle Characterization
In-depth particle characterization provided directional data informing our reformulation strategy. Raman spectroscopy revealed the presence of both proteinaceous and fatty acid based (sub-)visible particles. Fatty acids are a known source of protein aggregation (1).
Step 2: Molecular Modelling
Molecular Modelling elucidated an additional sequence/structure related driver for aggregation and provided valuable input for an optimized stabilization strategy
Step 2: Molecular Modelling
Molecular Modelling elucidated an additional sequence/structure related driver for aggregation and provided valuable input for an optimized stabilization strategy
Step 2: Molecular Modelling
Molecular Modelling elucidated an additional sequence/structure related driver for aggregation and provided valuable input for an optimized stabilization strategy
(1) Fatty Acids Can Induce the Formation of Proteinaceous Particles in Monoclonal Antibody Formulations (Zhang et al., J Pharm Sci, 2022
(1) Fatty Acids Can Induce the Formation of Proteinaceous Particles in Monoclonal Antibody Formulations (Zhang et al., J Pharm Sci, 2022
Step 3: Successful Reformulation
After iterative rounds of DoE-based screening and optimization, four formulations were selected for a confirmatory stability study at recommended storage conditions (5°C ± 3°C) for 6 months. Formulations 01 and 02 were exempt of visible particles at the study end point. Also, other critical quality attributes (CQAs) remained stable.
For over 20 years, Leukocare has helped biopharma teams develop better biologics faster — through smart formulation strategies, predictive tools, and a collaborative mindset.
For over 20 years, Leukocare has helped biopharma teams develop better biologics faster — through smart formulation strategies, predictive tools, and a collaborative mindset.
Hear from our experts
Connect with Our Team to Improve Product Safety and Stability
Ulrike Konrad, VP Business Development
Hear from our experts
Connect with Our Team to Improve Product Safety and Stability
Ulrike Konrad, VP Business Development
Hear from our experts
Connect with Our Team to Improve Product Safety and Stability
Ulrike Konrad, VP Business Development