Identification of visible and subvisible particles in (bio)pharmaceutical samples
Particles in the visible and subvisible size range can appear in (bio)pharmaceutical samples and drug products during all stages of development and even after market approval. The presence of particles can indicate an insufficient stability of the active pharmaceutical ingredient or issues with the production process and can negatively influence the safety and efficacy of the therapy. Particles can:
- directly derive from the active pharmaceutical ingredient (API) e.g., due to an insufficiently stable therapeutic protein
- be introduced by formulation excipients e.g., as degradation products or particulate impurities
- be generated by the production process e.g., during pumping or filtration steps
Particle identification for trouble shooting with a quick turnaround time
Determining the origin and identity of particulate matter in (bio)pharmaceutical drug products is crucial for troubleshooting and root-cause analysis and, thus, often very time-critical. In such situations, Coriolis can analyze your samples with minimal lead time and deliver results right from the lab bench, so you can resolve the underlying cause of particle formation as quickly as possible.
Our identification approach includes the visual inspection of the sample inside the primary container, a high-resolution photo documentation of the particles and a subsequent identification of the isolated particles by a range of specialized analytical techniques, including FTIR microscopy, SEM-EDX and Raman.
In a first step, the presence of particles is inspected in the primary container by:
- Visual inspection
- High-resolution photo documentation
This gives an overall picture on the extent of particle contamination and enables the selection of samples for further analysis. In a second step, particles are isolated on a filter, preferably a metal-coated membrane or a gold filter, for subsequent identification with an array of specialized analytical techniques:
- Light microscopy
- FTIR microscopy
- Raman microscopy
An identification approach can be successful for particles larger than around 10 µm. Under certain circumstances, identification of particles suspended in liquid formulation (without prior isolation on a filter) may also be possible.
Identification of particles in your drug product
We offer the identification of particles based on many years of experience with a variety of biopharmaceutical samples and we will tailor it to your specific product type, development phase and material availabilities, if desired. Click on a product type to explore our entire portfolio of specialized analytical as well as research and development services.
Quality & biosafety level of this service
We provide all our services with the highest quality standards. Each project is carried out by experienced scientists and every report or data presentation is comprehensively checked by a scientific reviewer. We offer this service with the following quality and biosafety level:
From generic to custom analytical methods and beyond
We offer a large selection of generic analytical methods for many common applications or develop custom methods specific for your needs. Our expert scientists also perform a method feasibility to assess, which technique is most suitable for your request. We offer the following options:
Methods ready to use
Our expert scientists have established generic analytical methods for many common applications. This guarantees a quick turnaround for sample testing and reduces the need for method adjustments to a minimum.
We suggest generic methods for your sample based on our many years of experience with similar products and analytical questions. If you reach a development stage, where fully developed and documented methods are required, we can build upon our expertise in customizing and optimizing any analytical method.
During method development, we tailor sample preparation, method settings, and data analysis to the needs of your project and sample.
For this purpose, we include a representative sample and, where available, suitable reference standards and stressed/degraded materials. This way, our analytical scientists can design a method that is highly suitable for your needs, stability indicating, as well as robust and repeatable. Upon request, we compile a detailed method description for your records.
A method qualification is the initial assessment of the performance of an analytical procedure to show that it is suitable for the intended purpose.
During method qualification, our analytical scientists perform documented testing to establish and assess acceptance criteria in several performance characteristics. These may include repeatability, linearity, intermediate precision, robustness and more. We compile a qualification plan and a qualification report including all relevant data.
Our know-how related to particle identification
Coriolis is a science-driven service provider. We perform internal research projects with academic and industrial partners to develop new technologies and create in-depth knowledge, which directly benefits our client projects. Our internal Unit Science & Technology, hosting PhD candidates and Postdocs, also actively contributes to the scientific community with numerous peer-reviewed publications each year. Explore our latest publications, articles, and webinars:
Muhammad Umar, Nils Krause, Andrea Hawe, Friedrich Simmel and Tim Menzen
Our other services
Coriolis provides a wide range of science-driven and tailor-made solutions for research, development, and analytical challenges. Explore our other services and learn more about how we can support your drug development program. Together, we can make future therapies available to patients and improve the quality of life for humankind.