Functional Assays

Coriolis Pharma offers comprehensive functional assay services to evaluate the biological activity and efficacy of your biopharmaceutical compounds. Our expert analytical scientists develop tailored methods to assess the critical quality attributes (CQAs) of your drug product, supporting formulation development and ensuring the functionality of your therapeutic compound throughout its shelf life.

Functional Assays Tailored to Your Needs

Coriolis provides a range of functional assay types customized to your product and development phase.

Our collaborative approach allows us to develop methods that precisely meet your requirements, including:

Antibody binding affinity and specificity
Infectivity and titer determination for viruses and viral vectors
Ligand–receptor binding

We take a unique approach to method development, leveraging our broad scientific experience with diverse biopharmaceutical samples to tailor each assay to your specific needs.

Our functional assay services are performed under GMP conditions in dedicated labs with full quality oversight. These services can be applied to viruses, cells and viral vectors, and fall under biosafety level 2.

Functional Assay Methods

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

Virus titration / TCID50 assay Surface plasmon resonance (SPR) Enzyme-linked Immunosorbent Assay (ELISA) Cell-based assay (activity, infectivity, binding) Quantitative polymerase chain reaction (qPCR)

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 over 930 modalities, and the 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 biologics formulation development program from preclinical and early-phase development to the market.

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.