Medicinal products utilizing genetically modified organism (GMOs) offer many opportunities in addressing unmet medical needs and improving treatments for many diseases and injuries. The handling of such biological substances falls under one of four biosafety levels (BSL). Most of these products, which utilize e.g., adenovirus vectors or AAV vectors are categorized as BSL-1, while other, including lentiviral vectors, vesicular stomatitis virus-based vectors or chimeric antigen receptor (CAR)-T cells fall under BSL2.

Coriolis offers by default all services and analytical techniques for products up to BSL1. Extensive personnel training, dedicated work processes and specifically designed laboratories allow us to also offer a large selection of our services for products that fall under biosafety level 2.

We are your expert for handling potentially hazardous biological substances

With experienced project teams and dedicated facilities under BSL2, Coriolis is your trusted partner for the development and analytical characterization of virus- and cell based medicinal products. Already at an early stage, Coriolis provides tailored preformulation studies of candidates utilizing our broad analytical portfolio. Our scientists also plan and conduct entire formulation development programs for your virus- or cell-based product, aiming to obtain a stable liquid, frozen or lyophilized formulation. The latter includes a scientifically sound lyophilization process development from cycle optimization and robustness testing to scale-up and transfer. Stability and forced degradation studies support the formulation development efforts throughout all stages. In the final phase of development, Coriolis also offers in-use stability studies under BSL 2.

Upon project start, our experts assess the biosafety level of your product based on the provided information and file for work approval at the German competent authorities. We take care of the paperwork, so you can focus on the project and the scientific challenges ahead.