Project success stories
As an independent and accountable partner, Coriolis adds value to your project
As a privately held company we are independent and accountable to nobody except you, our client. Therefore, we can provide our services with solely data-driven recommendations. You and your project are at the center of our attention.
Working with Coriolis means that we assemble a team of specific experts to meet the demand of your particular project. In a unique collaborative approach, our interdisciplinary team will create an environment that focuses on fulfilling your goals and expectations.
We know that scientific discoveries and biopharmaceutical breakthroughs are difficult to plan ahead. That is why Coriolis offers a high degree of flexibility by applying a unique collaborative approach. We are your expert partner with pure client orientation.
Working with Coriolis makes the difference
On many occasions, our experienced and passionate scientists turned a challenging project into a success story by tipping the scale in favor of our clients. Our interdisciplinary teams are highly motivated and dedicate their scientific experience to the benefit of our client projects.
Project success stories:
Examples are anonymized to maintain the confidentiality of our clients and their projects
Changing a low concentration intravenous to a high concentration subcutaneous formulation
The challenge: Changing the application route of a monoclonal antibody from intravenous to subcutaneous and thereby increasing the concentration to 200 mg/ml. Initial development efforts by the client resulted in viscosity issues and protein aggregation.
The solution: Our scientists developed an innovative self-buffering formulation with only a few amino-acid additives that stabilized the protein and reduced the viscosity. The formulation met the target product profile (TPP) of the client.
The benefit of Coriolis: Our liquid formulation group has successfully developed multiple high concentration protein formulations. They apply their knowledge gained from working with hundreds of different drug products to the benefit of your project.
Overcoming challenges for AAV analytics
The challenge: An early-stage adeno-associated virus (AAV) preparation showed a very low titer and high quantities of cell debris. The client needed a detailed characterization and quantification of empty, partially filled, and full capsids.
The solution: After screening different analytical approaches for their feasibility, including ion-exchange chromatography and transmission scanning microscopy, we could successfully develop an analytical ultracentrifugation method, which accurately quantified the three species in the samples.
The benefit of Coriolis: Coriolis has a large portfolio of 100+ analytical techniques and is also the largest provider for AUC services worldwide. With many analytical experts, we can push the limits of our techniques to the benefit of our clients.
Overcoming surfactant degradation issues
The challenge: A client observed surfactant degradation in a drug product batch. As this may negatively impact product stability and safety, regulatory authorities expected an assessment and root-cause analysis of the issue.
The solution: With a set of dedicated surfactant characterization methods, we could identify hydrolysis as the main degradation pathway. This was found to be caused by residual host cell proteins inside the product. The client could optimize the down-stream procedure and solve the issue.
The benefit of Coriolis: We are the analytical expert for surfactant characterization with several peer-reviewed publications about this topic. We offer a large selection of surfactant characterization techniques including LC-CAD and LC-MS and perform particle characterization to e.g., identify fatty acid particles. This allows our expert scientists to give data-driven and precise improvement suggestion to clients for optimization.
Successful trouble shooting solves manufacturing issues
The challenge: A biopharmaceutical drug product for clinical trials showed elevated particles in several batches. The production was stopped, and Coriolis was contacted to investigate the issue.
The solution: After assessing several in-process samples and final products by using specialized particle characterization and identification techniques, we could identify a pump tubing to be the source of particles. Changing the product type of this tubing resolved the issue.
The benefit of Coriolis: Beside a large portfolio of specialized analytical techniques, our project groups have in-depth knowledge about the criticality of individual production steps and potential stress situations for the drug product. This allows us to perform a focused troubleshooting with little turn-around time.
Identifying inline filter as source of particles during clinical application
The challenge: A therapeutic protein product with a good stability profile in the primary packaging, showed elevated quantities of visible particles after in-use handling.
The solution: An in-use stability study was designed that included the identification of the visible particles. The particles could be identified as cellulose fibers originating from the in-line filter. Changing to an optimized type of in-line filter resolved the issue.
The benefit of Coriolis: We put together interdisciplinary teams of experts specific for each project. In this case, one of our many pharmacists experienced with clinical procedures and product handling was part of the team. Together with experienced analytical scientists performing particle identification, the team could identify the root-cause and solve the issue in a short timeframe.
Key benefits of Coriolis
By working with Coriolis, you will enjoy a number of benefits that will make your project a success from the very beginning. We aim to understand the individual needs of your project request and meet your expectation with tailored project designs and flexible solutions.