We support your lentiviral vector (LVV) project all the way to commercial manufacturing. From risk assessment to process characterization and process validation, you benefit from our expertise so you can manufacture your product in a timely fashion, at high quality, and with global regulatory support.
With our scalable manufacturing platform, commercial capabilities will be easier predictable. Take advantage of our platform process and scale-up that we’ve established and optimized in-house over decades. For planning your commercial LVV production, you can rely on our US and EU facilities that will support you to get from vector selection all the way to commercial batches – meeting your capacity requirements.
We apply our deep process knowledge to offer processes and vector backbones that are known by many regulatory authorities. And we make sure you have access to continuous improvements, state-of-the-art, single-use bioreactors and associated fill and finish, and production suites to support your programs.
For us, process characterization is a fully collaborative process, and we will support you wherever you are. We will take your input to fully align the path from initial process risk assessment, process characterization, and final process control strategy towards commercial production. For successful and fast process characterization, we start from a strong foundation with expertise that leverages our LVV platform. It all starts with a deep understanding of product-specific details, such as the quality target product profile (QTPP) and identification of critical quality attributes (CQA). Since many of the CQAs are platform-based attributes, we have an excellent starting point. Following the identification of CQAs, we conduct a process risk assessment and a unit operation parameter risk assessment. This output is used in a Quality-by-Design (QbD) approach to identify process hot spots with the need for closer characterization. We use this data to ultimately lead to the development of Design-of-Experiment (DoE) study plans. And since our qualified scale-down models of key unit operations are right in place, we enable follow-up process characterization and product-specific qualification without the intensive resource requirements of at-scale manufacturing.
Our Quality Management System is specifically designed to ensure regulatory compliance and the highest product quality possible. We support you on your way to IND and market approvals, as well as country-specific client needs. Our Biologics Master File and Regulatory Support Files are recognized in more than 50 countries already. We are happy to support your project as well.