Innovating today for what you will need tomorrow
Large-scale manufacturing of viral vectors in a cost-efficient manner is certainly one of the key challenges that the bioproduction of gene therapy products is facing today. Constantly improving processes yields and quality at every scale is at the core of our innovation efforts.
Our objective is to proactively adapt to the challenges of the evolving needs of our clients and continuously deliver on all commitments as a long-term, sustainable and competitive supplier.
We are working on increasing process productivity through a broad range of innovative technologies. For instance, we have developed two platforms for AAV and lentiviral vector manufacturing. Both platforms have been developed and proven over the years, they allow us to generate high yields using gold-standard equipment and reagents to maximize cost-effectiveness and reduce time to market. Proprietary ‘optimized’ transfection reagents and high-producer cell lines are used on these platforms.
Analytical methodology for cell and gene therapies is constantly evolving. Hence, we are continuously evaluating and implementing novel and next-generation methods for current and potential future product quality attributes. We do this by continuous technology scouting, and harnessing Analytical Quality by Design (AQbD) approaches, all combined with a forward-looking appreciation of analytical method lifecycle management to ensure we develop robust and durable analytical solutions. For many of these projects, we work with selected and reliable external partners.
For example, we have established partnerships working with companies in:
- Next Generation Sequencing, (NGS) to evaluate what types of DNA are being packaged into AAVs;
- Capillary electrophoresis as an additional method for AAV Empty/Full vector characterization and to enhance our current AAV and LVV protein analytical methods.
Genetically modified Cells (ex-vivo Gene Therapy)
Yposkesi works on the optimization of the transduction process of genetically modified cells, including CD34+ hematopoietic cells and T-cells. The activities focus on the automation of processes using robotics, the development of closed systems, the optimization of cell transduction, cryostorage, and also the development of analytical methods for product characterization (identity, purity, and potency assay). We have a dedicated lab area for that activity, including two class B rooms and a Quality Control (QC) lab.