Analytical services for biopharmaceuticals from the scientific expert
Coriolis Pharma is the scientific expert in analyzing biopharmaceutical product samples. From peptides and proteins to nucleic acids, viral vectors, and cell-based products; from high concentration antibodies to low concentration hormones; from early-stage drug substance to complex late-stage drug products: We consider the specific needs of your project and your analytical challenge, and tailor for you the most suitable set of cutting-edge analytical strategy and methods.
Our analytical portfolio comprises 100+ different techniques – all performed by Coriolis’ experts in-house. Our analytical scientists have unmatched know-how in their field and able to push the limits of what’s possible. We put together a dedicated method development plan tailored to your analytical challenge and include orthogonal techniques, if desired and where appropriate, to not leave any blind spots in our results.
You benefit from many years of experience
Coriolis is the trendsetter in the field of analytical services for biopharmaceuticals. Since 2008, we are solving analytical challenges with innovative solutions by testing and implementing the latest analytical technology. For each individual project, our expert scientist will devise the most suitable set of analytical methods to obtain robust and meaningful data.
Analytical service applications
With our comprehensive analytical portfolio, we can tackle a large range of analytical challenges. In a unique collaborative approach, we suggest a set of suitable techniques specific for your request and product type. Here are some examples of analytical service applications.
The physico-chemical comparability, including comparability of stability profiles, is required for the development of biosimilar drug products, but can, among other scenarios, be crucial when comparing batches from different production processes or manufacturing facilities.
By using sensitive analytical methods and by applying relevant conditions for stability testing, we set up comparability studies specifically for your drug product. We provide the required experience and scientific know-how to detect critical differences between your samples with statistical relevance.
Have you experienced an out-of-specification (OOS) result that impacts your production or development process? Do you require a trouble shooting exercise from an interdisciplinary team of experts?
With a quick turnaround time, Coriolis will put our most experienced scientists to the task. They will consider formulation as well as production aspects and apply our large portfolio of cutting-edge analytical techniques to investigate the root cause of your OOS, so you can get back on track fast.
We evaluate the stability of your drug product during long-term storage, under accelerated stress conditions and during in-use procedures.
To identify the most stable formulation, we compile a set of orthogonal methods from our large portfolio of analytical techniques and develop suitable and phase-appropriate analytical methods. We set up storage conditions following ICH guidelines or develop suitable stress conditions specific for your drug product and target product profile.
Analytical studies to answer questions from the regulatory authorities
Have you received feedback and comments from regulatory agencies requesting additional data on one of the following examples:
Characterization of subvisible particles as part of your drug product analytical strategy, that goes beyond USP<788> or EP 2.2.19. Elucidation of aggregation mechanisms or kinetics. Analysis of polysorbate content for your drug product and/or elucidation of degradation pathways during drug product stability.
We support you with a tailored study design that will allow you to confidently get back to the authorities with answers to their questions.
Our analytical service categories
We offer a large selection of analytical techniques in a variety of categories. In each category we employ the latest in technology run by expert analytical scientists. You can choose your own set of analytics or get an expert opinion on the best choice of methods from us. Explore our portfolio ranging from discovery phase analysis to lot release testing methods.
Standardized methods or dedicated method development
Coriolis can significantly reduce your method development efforts, so you get your results faster with no compromise on data quality. Depending on your analytical challenge and development phase, we offer standardized analytical methods, already developed in house, or perform an in-depth method development or method optimization tailored to your product type, development phase, and analytical challenge. Our experienced scientists will ensure that the method meets your specific requirements.
Method qualification and validation
Within our Good Research Practice (GRP) system, we perform a detailed assessment of method performance, i.e., method qualification for all our analytical techniques in an R&D environment. On top of that, we operate a selection of methods on fully qualified equipment in a dedicated cGMP environment, allowing for method validation/verification. We perform lot release testing and generate of supportive data for market approval or enable tailored “enhanced R&D” level studies (e.g., qualified equipment but no QA involvement).