Please tell me about your viral clearance guarantee, why you are offering a guarantee, and why it is so rare in the industry.
Our viral clearance guarantee is a way for us to show our clients that we believe in our product. After designing the study to meet the expectations of our client and determining the level of viral clearance that we can obtain based on preliminary testing, we will achieve the agreed-upon level of clearance or we will perform additional testing at no cost.
What is your approach to study design and how does your relationship with each client enable a level of customization not available anywhere else?
We view study design as a collaboration between the client and us. We have detailed discussions with the client regarding the product purification process and the clearance targets for each individual spiking virus. Using this information and our extensive experience in viral clearance, we design the study to achieve the client’s clearance targets. We then discuss the study design in detail with the client so they have the opportunity to ask any questions or raise any concerns. We want them to understand not only the final study design, but also how we arrived at it.
Please describe your team approach when working with clients and how your experience and expertise lead to a better study design.
Our management team has over 80 years of combined experience in viral clearance. We have an on-going best practices program to evaluate and optimize all the parameters of study design and performance. In addition, our management team is actively engaged with global regulators and other industry leaders in this area. As a result of our extensive experience, we will evaluate multiple options for performing a study and offer a design that we can recommend and guarantee as the best way of achieving viral clearance targets.
The pharmaceutical industry is highly regulated. How does your knowledge of regulations help your clients and what can they expect in terms of regulatory support?
Our senior management team has been on multiple task forces and has helped many clients defend their data to regulatory agencies. As a client, you will have direct access to senior management when discussing projects, goals, and final data. We will provide regulatory support for the life of your product.
Can you describe the different levels of study options you offer?
We offer several study options ranging from basic virus spiking to a complete turnkey model. For our Basic Service model, we provide the virus spike and the client is on site to perform each process step. The client is also on site for our Enhanced Service model, but our staff will perform the less complicated steps (e.g., inactivation and viral filtration steps). For our Full Service model, we perform a technology transfer of the scaled down model (previously qualified by the client), and then our staff will perform the entire study without the client being present. Finally, our Turnkey Service model involves design and qualification of a scale down model and performance of the complete viral clearance study. The final data includes a CMC-ready scale down and viral clearance reports.
Tell me about your new state-of-the-art facility. What features and benefits does it provide to your clients?
Our new facility has four completely independent client suites, including laboratory and office space, which are conveniently located, providing constant access to our personnel during a client’s stay. Each suite has separate keycard access, keeping all client information confidential. We have multiple AKTA chromatography systems, as well as essential equipment needed for the study. Beyond our state-ofthe- art instrumentation and facilities, we have some of the industry’s top scientific talent who transform science into an outstanding service experience. Approaching each study as a vested partnership, when a client’s study succeeds, we succeed.