Biological safety levels
Science-driven services for drug products and samples up to biosafety level S2
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.
Our specialized services under biosafety level S2
Coriolis offers many of its services under biosafety level S2 and we are constantly adding new services and analytical techniques to our portfolio. Here are some prominent examples of how you can benefit from our services under BSL-2 / S2.
Formulation development for liquid and lyo
Formulation development is essential for the therapeutic and commercial success of a promising drug substance. Having a robust product that is robust against manufacturing, storage, handling, and administration is crucial already at early stages.
We develop liquid, frozen and lyophilized formulations that fit the needs of your drug product and development phase.
Lyophilization process development
Lyophilization is a valuable alternative to liquid formulation to achieve a stable drug product for many fragile (bio)pharmaceutical drug substances.
In our dedicated lyophilization development center, we develop robust and economical freeze-drying cycles suitable for production and tailored to the requirements of your product and the needs of your development phase.
Virus titration and infectivity assays
Titer and infectivity are important attributes of a virus preparation, and their analytical characterization is a central part of development, manufacturing, and quality control of gene therapy products.
Our scientists develop and apply tailored TCID50 and plaque forming assays to obtain infectious titers for your virus formulations. Further we provide qPCR to determine the viral genome copies. Above that, we offer a large portfolio of particle characterization techniques to quantify virus particles i.e., obtain physical titers.
Development of analytical methods
A sensitive and orthogonal characterization of the drug product by using stability indicating and phase-appropriate analytical methods is important.
Our expert scientists operate over 100 different analytical techniques and are experienced in setting up dedicated methods specific for your drug product. We also perform method qualification and, in case of GMP equipment, also method validation or compendial method verification.
Select your product type
We offer a large portfolio of science-driven and flexible services for development and analytical projects. We tailored each project to the specific needs of your product and development phase. Select your product below and explore our diverse portfolio of services.