Example: Oligonucleotides
It is probably well known that oligonucleotides play a key role in the development of new and effective preparations for targeted and highly efficient control of rare or hitherto difficult-to-treat diseases. For some time now, we have built up a comprehensive analytical service that supports our customers through development, clinical studies, and even commercialisation.
Our strength lies in combining the generally complex analytical methods and compliance with the phase-dependent GMP requirements. In this way, we support our customers on the path from research & development to market release and beyond.
We implement and validate the necessary product-specific methods for the purity and content determination of the active substance and its formulations, and we can use high-resolution UPLC methods and LC-MS coupling for this purpose. Dissolved dosage forms are examined by us using all common characterisation methods, whether in vials or in syringes (e.g. osmolality, particles, sterility, microbiological purity, endotoxins, sliding force, various methods for characterising the containers and stoppers, etc.). In addition to the analytical release of the batches produced, we also perform various studies to determine the shelf-life criteria, such as in-use studies, freeze-thaw studies, and similar stress tests, but also long-term studies under various climatic storage conditions. Since oligonucleotides are often very expensive to produce and the amount available is very small, especially in the early phases, we have developed various strategies that our customers can use to keep the need for samples for analysis and stability studies as low as possible.
From the very start of collaboration, we strive to be accessible and transparent to our customers with regard to agreements, goals achieved, data obtained and the next steps. We ensure this by seeing to it that every customer is supported by a dedicated contact person and is always kept up to date. Any questions and suggestions are discussed, whether by email, telephone or in regular project meetings.
