Analytical Services

Coriolis Pharma provides comprehensive analytical services under R&D and GMP conditions for all stages of development, from preclinical to commercialization. With a portfolio of 200+ methods performed in-house by our analytical experts using state-of-the-art instruments and technologies, we ensure accurate, reliable and on-time data. This allows you to maintain the highest quality and compliance standards, expediting your path to market.

Analytical Services

Coriolis Pharma’s non-GMP and GMP analytical services, designed and delivered by our team of experts, allow us to serve as an early accelerator, a collaborator for out-of-specification (OOS) events and other challenges, a resource for answering questions posed by regulatory authorities and a risk mitigator for the demands of preclinical research, CMC and process development. We are also your go-to partner for supporting late-phase development and commercial-release activities.

Aggregate Analytics

Evaluate the aggregation state of biopharmaceuticals to ensure product stability and efficacy.

Particle Characterization

Analyze the size, distribution and morphology of particles in drug formulations to maintain product quality.

Particle Identification

Identify and characterize particulate matter in drug products to ensure safety and compliance.

Surfactant Characterization

Assess surfactant concentration and degradation products in formulations to optimize stability and performance.

Higher-Order Structure Analysis

Determine secondary, tertiary and quaternary structures of biopharmaceuticals to ensure proper folding and functionality.

Functional Assays

Conduct bioassays to measure the biological activity and potency of drug products.

Chemical Change Analysis

Monitor chemical modifications of the active pharmaceutical ingredients to ensure product integrity over time.

Lyophilizate Analytical Services

Provide comprehensive analysis of lyophilized products to ensure their stability, reconstitution properties and overall quality.

Container Closure & Integrity Testing

Verify the integrity of container closure systems to prevent contamination and ensure sterility.

Basic Formulation Characterization

Perform fundamental tests to assess the physicochemical properties of drug formulations for optimal development.

Stability Testing

Conduct ICH-compliant stability testing within standard temperature ranges to address product-specific requirements.

Release Testing

Release testing ensures that the clinical or commercial batch achieves the target product profile and meets stringent quality control standards.

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.

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.

Antibody or Related Product

Peptide

Therapeutic Protein

Gene & Cell Therapy

Viral Vector

Nucleic Acid

Vaccine

Nanoparticulate Delivery Systems

Your Phase

Our expert team has the expertise and experience to guide your program from discovery to preclinical drug development, through clinical phases and to the market. Phase-appropriate analytics under R&D or GMP as required.

Preclinical

Early Phase

Late Phase & Commercialization

Commercial Services

Coriolis Effect

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

Analytical Services Project Success Story

Overcoming Surfactant Degradation Issues

The Challenge

A client observed surfactant degradation in a drug product batch. As this may negatively impact product stability and safety, regulatory authorities expected an assessment and root-cause analysis.

Our Solution

With dedicated surfactant characterization methods, we could identify hydrolysis as the primary degradation pathway. Residual host-cell proteins inside the product caused this. The client could now optimize the downstream procedure and solve the issue.

The Coriolis Effect

We are the analytical experts in surfactant characterization, with several peer-reviewed publications exploring this topic. We offer a wide selection of surfactant characterization techniques, including LC-CAD and LC-MS, and perform particle characterization to identify fatty acid particles, allowing our expert scientists to give data-driven, precise improvement suggestions to clients for optimization.