Yposkesi being a pioneer in the Contract Development and Manufacturing Organizations (CDMO) field for viral vector manufacturing, we have developed an ecosystem over the years with a strong supply chain network and two dedicated platforms for lentivirus and Adeno-Associated Virus (AAV) manufacturing. The key elements of our cell and gene therapies ecosystem are:
- Supply agreements for equipment, plasmids, and raw materials: We always make sure that the best products and equipment are used in our AAV and lentivirus platforms to develop your cell and gene therapies;
- Proprietary cell bank and transfection reagent (possibility to out-license as part of a lifecycle manufacturing agreement): Our AAV and lentivirus platforms are optimized, streamlined, and ready to manufacture your product to reduce time to market;
- A team of analytical experts: Able to design and implement standard analytical methods or specific methods for your product or process (development, transfer, qualification, or validation studies): 75% of analytical tests are performed in-house and an external network is well-established for specialized testing. Learn more about our analytical expertise. Learn more about our analytical services: click here.
Capitalizing on decades of experience in viral vector manufacturing, both Yposkesi’s platforms are proven and have already manufactured more than 215 viral vector batches. Among the 215 batches already produced, 70 are batches of viral vectors that have supplied clinical trials in Europe and in the United States.
Driven by a strong quality and safety culture, our viral vector manufacturing experts optimized and streamlined the AAV and lentivirus platforms to reduce time-to-market for your cell and gene therapy products.
Our scientists are specialized in lentivirus and AAV manufacturing, the two viral vectors which are respectively ranked first and second among the vectors used for cell and gene therapy trials, which is why we have developed two manufacturing platforms :
LentiSure™: Lentiviral-based processed platform
With an increasing number of cell therapy in ongoing clinical trials, the need for lentivirus manufacturing is more pressing than ever. Yposkesi’s LentiSure™ is the cell and gene therapy reference for lentivirus manufacturing, offering lentiviral vectors with high productivity and all the necessary validated analytical methods to ensure a safe and effective product. On top of that, LentiSure™ is a proven and optimized lentivirus manufacturing platform with a robust, scalable, and plug-and-play process.
Access to LentiSure™, which was created for both adherent and suspension processes, will give you access to a cost-effective streamlined environment to save time and market your cell and gene therapy faster.
AAV-based processed platform
AAV is one of the most popular viruses utilized as a viral vector in cell and gene therapies. When utilized as a viral vector for cell and gene therapies, this non-integrating vector offers several benefits.
Our AAV platform is suitable for suspension systems and is streamlined to shorten the time to market of your cell and gene therapy products. Based on a HEK-293 cell line, our AAV platform uses a proprietary optimized transfection reagent.
Shake flasks and single-use bioreactors are available for the suspension process of the platform.
Frequently Asked Questions (FAQs)
A viral vector manufacturing platform is a succession of upstream (USP) and downstream (DSP) manufacturing unit operations with the goal of producing viral vectors. The platform is proven and has been developed over a number of years by our team of highly qualified experts. At Yposkesi, we have more than 30 years of experience in viral vector manufacturing and two platforms for AAVs and lentiviral vectors.
To produce cell and gene therapies, drug producers often rely on viral vectors. According to the last Alliance for Regenerative Medicine (ARM) report, lentivirus and AAVs are the most common vectors used for cell and gene therapy drugs.
- Primarily used to target dividing cells;
- They are integrating viral vectors meaning that they will stably integrate into the genome of the target cell;
- Bigger packaging capacity; useful for larger inserts.
- They are non-integrating, episomal; can be considered safer (lower risk of insertion-related safety events;
- Can infect a wide range of cell types, including both dividing and non-dividing cells;
- Smaller packaging capacity; suitable for delivering smaller transgenes.
Both vectors meet the current Good Manufacturing Practices (cGMP) guidelines. Indeed, compliance with FDA cGMP regulations is essential for drug manufacturing.