Particle Identification

Observing visible and subvisible particles can stagnate the drug development or the batch release process. Coriolis Pharma has the experience and the capacity to determine the identity and possible origin of particulate matter in your biopharmaceutical drug products—crucial for troubleshooting and root-cause analysis. Our experts can analyze your samples with minimal lead time and deliver results from the lab bench so you can resolve the underlying cause of particle formation.

Particle Identification Tailored to Your Needs

Particles in the visible and subvisible size range can appear in biopharmaceutical samples and drug products during all stages of development and even after market approval. The presence of particles can negatively influence the safety and efficacy of the therapy.

They can be introduced to a therapeutic in several different ways, including:

  • Directly derived from the active pharmaceutical ingredient (API), for example, due to an insufficiently stable therapeutic protein (intrinsic particles)
  • Be introduced by formulation excipients, for example, as degradation products or particulate impurities (inherent particles)
  • Be generated by the production process, for example, during pumping or filtration steps (extrinsic particles)

Troubleshooting with Rapid Particle Identification

Determining the identity and possible origin of particulate matter in biopharmaceutical drug products is crucial for troubleshooting and root-cause analysis, and therefore, it is often very time sensitive. If required, Coriolis experts can analyze your samples within a matter of days so you can quickly resolve the underlying cause of particle formation.

Particle Identification Testing Methods

We can select the most suitable approach for your analytical challenge, whether following a standardized in-house workflow or a custom-tailored solution.

Analytical Method Development, Qualification and Validation

For common sample types, we can often apply standardized methods with little setup effort. However, when needed, our experienced analytical experts create or optimize custom methods tailored to your active pharmaceutical ingredient, product type and development phase.

Method Development

Our method development approach tailors sample preparation, method settings and data analysis to the needs of your project and sample.

We include representative samples and, where available, suitable reference standards and stressed/degraded materials, allowing our analytical scientists to design a highly suitable, stability-indicating, robust and repeatable method. Upon request, we will compile a detailed description of the method for your records.

Method Qualification

Method qualification is the initial assessment of an analytical procedure’s performance to show its suitability for its intended purpose.

During method qualification, our analytical scientists perform documented testing demonstrating that the analytical procedure meets criteria in several categories. Criteria may include factors such as repeatability, specificity and robustness. We compile a qualification plan and report, including all relevant data.

Method Validation

Under GMP conditions, method validation confirms that an analytical procedure’s performance suits its intended purpose. Depending on the method’s scope, a broad range of method characteristics, such as specificity, accuracy, precision, limit of detection/limit of quantification (LOD/LOQ), linearity and range, is considered.

During method validation, our analytical scientists perform documented testing demonstrating that the analytical procedure consistently produces a result that meets the predetermined acceptance criteria. We compile a validation plan and report that includes all relevant data.

Depending on the development phase, a fit-for-purpose validation approach can be offered, adjusting the validation required efforts in a phase-appropriate way to meet the method’s needs.

Method Verification

Compendial method verification confirms that a compendial method (e.g., from Ph. Eur. or USP) is suitable and reliable for its intended purpose under the specific conditions of the laboratory.

Unlike full method validation, compendial method verification is often considered a partial validation since the method has already undergone extensive testing and validation during its inclusion in the compendium. The extent of method verification depends on the type of method.

During method verification, our analytical scientists perform documented testing demonstrating that the developed analytical method performs adequately for the specific product or matrix being tested and within the specific laboratory where the method will be employed.

We’ve worked with more than 930 compounds, and that number is growing by the day.

Particle Identification for Your Drug Product

Coriolis Pharma’s deep expertise across many biologic modalities, combined with input from world-leading external advisors, offers the knowledge and experience needed to solve even the most complex formulation and drug development challenges.

Your Phase

Our expert team has the expertise and experience to guide your biopharmaceutical development program from preclinical and early-phase development to the market.

Coriolis Effect

See how our expertise and comprehensive services accelerate biologics development from preclinical to the market.

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Talk to Our Experts or Request a Quote

Our expert team is ready to answer your questions and guide you to the services best suited to your program’s modality, stage and challenge. If your needs are well-defined, we’ll begin the quotation process.

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