Advanced therapy medicinal products (ATMPs) – Biosafety level 2
Formulation development and characterization of viral vectors & other ATMPs
ATMPs – including gene- and cell therapy medicinal products – offer new opportunities in addressing unmet medical needs and improving treatments for many diseases and injuries. Coriolis supports the development of ATMPs with a focus on formulation development and characterization of viral vectors, such as adeno-associated virus (AAV) and lentivirus vectors. Our services are also available for other drug products utilizing genetically modified organisms (GMOs) up to biosafety level (BSL) 2.
Our service portfolio under BSL2
Already at an early stage, Coriolis provides a tailored manufacturability / developability assessments of candidates utilizing our broad analytical portfolio. Our scientists also plan and conduct entire formulation development programs for your product, aiming to obtain stable liquid 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.
Cutting edge analytical characterization lays the foundation for every drug product development
With more than 10 years of experience in the field of aggregate analytics and particle characterization, Coriolis employs numerous cutting-edge methods in the nano- and micrometer-size range under BSL 2, which are perfectly suited for the analysis of particulate systems including ATMPs, virus formulations, vaccines and GMOs. For each project and product, we carefully select a set of robust methods for orthogonal analysis, delivering reliable data during all phases of formulation development.
Besides quantification, another crucial parameter during the development of a viral vector formulation is its infectivity. Therefore, we include TCID50 assays during the development of ATMPs to determine the tissue culture infectious dose.
Coriolis also offers a number of analytical techniques under BSL 2 as contract analytical services.
Contact our experts today and find out how we can support your drug product development.