We can help you reach your goals from process development up to commercialization:
With specific manufacturing platforms
Developed over the years, our rAAV and rLVV platforms benefit from the use of high producer cell lines and a proprietary ‘optimized’ transfection reagent.
With multiple Process Development Laboratories
We offer flexibility to develop the best process depending on your needs. Your Cell and Gene therapy product being unique, the manufacturing process for viral vector will be unique as well.
With a total of four independent cGMP manufacturing suites available to develop your ATMPs:
• Suspension systems: cGMP total capacity of 2,000 L with bioreactors from 200 L up to 1,000 L;
• Adherent systems: cGMP capacity of 24 x CF10.
With two cGMP aseptic and semi-automated fill and finish suites:
• Total capacity of 9,000 vials per year;
• Using Crystal® Closed Vial Technology (Cyclo-Olefin Co-polymer) and Glass vials (250 μl up to 4,5 ml);
• We are currently working on the implementation of a fully automated Drug Product fill & finish line.
In order to decrease risks of contamination, our processes employ single use equipment
Yposkesi being a full-service CDMO, we also provide:
• Analytical Development: Using Quality by Design concepts;
• Quality Control: Robust and reliable methods, validated according ICHQ2R1 guidelines;
• Quality Assurance: Full cGMP, ICHQ10 based QMS;
• Regulatory Support: To help you successfully navigate the administrative process;
• A single point of contact Project Manager: To ensure smooth and efficient communication between our teams and organize regular meetings to meet your timelines and budget.