Quality under GMP and R&D
Highest quality from early-stage to market release and beyond
Coriolis is a leading provider of research, development and analytical services for biopharmaceuticals. Our mission is to build quality into all our services as an enabler for efficient and sustainable drug development, which will help to improve quality of life of mankind.
Through a comprehensive quality assurance system, we ensure the highest quality of our services on both R&D- and GMP-level. We offer R&D services from early-stage research phase, where we support your development efforts with flexible and tailor-made services, all the way to and beyond clinical trials, where we offer services in GMP compliance in dedicated facilities with full QA involvement.
Best quality of work already at R&D-level
Coriolis operates all R&D projects under a customized Good Research Practice (GRP) system. This assures operational excellence of lab procedures consistently performed under high industry research standards with high level data integrity, traceability, and documentation. We optionally offer source data review, dedicated method descriptions and certificates of testing under R&D. Our GRP system assures the highest quality from sample receipt all the way to the final report.
Services under full GMP
Coriolis has received GMP accreditation by the local surveillance authority for the quality control testing of excipients, active ingredients and medicinal products and we have been re-inspected by the authority and are regularly audited by our clients successfully. GMP compliant analysis is performed on qualified state-of-the-art instruments and utilizes carefully developed and comprehensively validated methods. Full GMP documentation and involvement of Quality Management allows us to perform lot release analysis and generate supportive data for market approval.
Benefit from our “enhanced R&D-level” studies
Within our GMP facilities we also serve clients requesting performance of non-GMP studies in a controlled (GMP) environment. This permits the utilization of fully qualified equipment but still allows the flexibility of an R&D project. The quality level can be tailored to your needs - contact us for your tailor-made study design.
Our specialized services under GMP compliance
Coriolis offers many of its services under full GMP compliance and we are constantly adding new services and analytical techniques to our GMP portfolio. Here are some prominent examples of how you can benefit from our GMP expertise.
Analysis of particles and aggregates
The analytical characterization of subvisible and visible particles as well as aggregates of the (proteinaceous) drug substance is a vital part of the product testing during drug development and for lot release analysis.
We at Coriolis have a strong focus on the analysis of (sub)visible particles and aggregates and offer compendial and supportive methods under full GMP compliance. Our analytical spectrum allows for particle quantification, visualization, and classification. We offer low volume methods for e.g., ophthalmic products and develop dedicated methods for your product, if required.
The quality requirements for pharmaceutical grade polysorbate 20 and 80 are specified in the different pharmacopoeias. Further, the ICH countries agree on the key requirements, such as impurity levels and fatty acid composition.
Our experts have a strong scientific background in quantifying and characterizing surfactants in drug products. We develop dedicated methods for each product based on our established and proven in house approaches for e.g., charged aerosol detectors (CAD) in combination with liquid chromatography (LC) or an innovative fluorescent analytics approach.
In-use stability studies
In a clinical setting, a drug product may be diluted and encounters different surface materials before it is finally administered to the patient.
Therefore, our expert scientists assess the stability of a drug product during clinical use and handling, e.g., effects of dilution, compatibility with clinical diluents and materials, etc. We tailor such studies to the intended procedures and utilize a dedicated set of stability indicating analytical methods.
Virus titration and infectivity assays
Titer and infectivity are important attributes of a virus preparation, and their analytical characterization is a central part of development, manufacturing, and quality control of gene therapy products.
Coriolis offers a variety of methods to obtain virus titers and infectivity information. Our scientists develop and apply tailored TCID50 and plaque forming assays to obtain functional titers for your virus formulations. Above that, we offer a large portfolio of particle characterization techniques to quantify virus particles i.e., obtain physical titers.
High quality services tailored to your product
We offer a large portfolio of science-driven and flexible services for research, development and analytical projects. We tailored each project to the specific needs of your product and development phase. Select your product below and explore our diverse portfolio of services.