No matter which problem you are facing during process development or how urgently you need to find the source of an error, Coriolis has many years of experience in troubleshooting processes during manufacturing or product development. We offer short reaction times and deliver quick results so that you can continue making high-quality drug products using robust processes.
Coriolis employs a large portfolio of cutting-edge orthogonal techniques to perform in-depth particle characterization and identification. We are trendsetter in the field and offer you the newest in technology and the latest in scientific knowhow.
Biological drug products that aim to be biosimilar to or interchangeable with an originator drug product need to demonstrate physico-chemical comparability (including stability profile). These comparability studies are an integral part of any biosimilar drug product development. Coriolis offers a large portfolio of orthogonal techniques, many years of experience in handling originator and biosimilar drugs as well as cutting-edge scientific knowhow to ensure the success of your biosimilar drug product development.
In a clinical setting, a drug product may be diluted and encounters different surface materials (such as tubings, infusion bags, pumps, closed system drug transfer devices) before it is finally administered to the patient. Therefore, any drug product development needs to assess the in-use stability, e.g., after a dilution or its compatibility with commonly used clinical diluents and clinical materials. Coriolis has more than 10 years of experience in simulating a large variety of in-use scenarios. In combination with our large portfolio of analytical techniques, we deliver in-depth information about the drug product’s in-use stability.
Stability studies play a central role during any drug development program. Coriolis offers a variety of different climate chambers operated at controlled temperature and relative humidity, various fridge and freezer setups. Storage according to ICH guidelines as well as virtually any other tailor-made storage condition can be generated. Stability studies are supported by our large portfolio of cutting-edge analytical techniques to enable an in-depth analysis of product stability.
It is essential for any drug product development to challenge the stability of drug product candidates in order to identify the most robust and stable one. Coriolis has over 10 years of experience in setting up tailor-made forced degradation studies and our scientists can rely on a large variety of cutting-edge analytical techniques for an in-depth analysis of product stability