ANALYTICAL SERVICES FOR BIOPHARMACEUTICALS
Analytical Services under R&D and GMP
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 liquid to freeze-dried solutions; 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, systems 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 are 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.
Highest Quality and Security Standards
Analytical Support up to GMP and Biosafety Level S2
We always keep an eye on the entire development process of your drug product and support you throughout the biological life cycle, from analytical method development and validation to clinical testing and market release of your product. At each stage, our experts will advise you on what tests are needed to move your development project forward and recommend the right analytical tests under R&D or GMP conditions through to market approval of your drug product. Each project is carried out by experienced scientists and every report or data presentation is comprehensively checked by a scientific reviewer.
Innovative drugs such as gene- and cell therapy products frequently utilize genetically modified organisms or biological substances that fall under biosafety level S1 or S2. In our facilities, we can analyze drug substances up to biosafety level S2. With dedicated biosafety officers, we monitor and take care of the biological safety assessment and regulatory paperwork to get project work stated as quickly as possible.
Method Development, Qualification, Validation
Method Development and Optimization
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 product-specific and phase-appropriate method meets your specific requirements under R&D and GMP.
Method Qualification and Phase Appropriate 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 and verification. We perform lot release testing and generate supportive data for market approval or enable tailored “enhanced R&D” level studies (e.g., qualified equipment but no QA involvement).
GMP and R&D Related Services
Phase-Appropriate Services under GMP and R&D
We offer a wide range of analytical techniques in a variety of categories. In each category, we use the latest technology operated by expert analytical scientists combining many years of experience. You can choose your own set of analytical methods or get an expert opinion from us on the best choice of methods for your development stage. Explore our portfolio from discovery phase analysis to lot release testing methods and tech transfer support.
Applications
Let's tackle your challenge!
Our comprehensive analytical portfolio allows us to address a wide range of analytical challenges. In a unique collaborative approach, we propose a set of appropriate techniques specific to your request and product type. Here are a few examples of analytical service applications.
Comparability studies
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.
We offer this service under R&D and up to Biosafety Level S2
Trouble-shooting activities
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 offer this service under R&D and up to Biosafety Level S2
Stability studies
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.
We offer this service under R&D and GMP and up to Biosafety Level S2
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.
We offer this service under R&D and GMP and up to Biosafety Level S2
Contact us
Contact us
Please contact Dr. Jörg Müller with your inquiries related to analytical services
Phone: +49 89 41 77 60 – 111
Mail: joerg.mueller@coriolis-pharma.com
