cGMP manufacturing of clinical & commercial batches
30+ years' experience in Cell & Gene Therapy
Fully equipped for viral vector manufacturing according to current Good Manufacturing Practices (cGMP) guidelines, Yposkesi’s current facility has four independent and multiproduct manufacturing suites.
Key elements about our cGMP manufacturing suites:
- Total of 2,000 m2 of Bio Safety 2 – Grade C;
- Possible to perform both AAV (Adeno-Associated Virus) and Lentiviral production in suspension and adherent systems with proven dedicated platforms;
- For adherent cell culture, cell factories are used, from 4x to 24xCF10;
- For suspension cell culture, the total capacity is 2,000 L in single-use bioreactors: 5 x 200 L and one 1,000 L and this will increase to 6,000L in 2023;
- Our total cGMP baseline production capacity is up to 32 cGMP batches per year with 8 batches per cGMP production suite;
- Typical purification steps performed in these cGMP manufacturing areas include depth filtration, tangential flow filtration, and chromatography (affinity, ion exchange, and size exclusion);
- Contact us to learn more about our cGMP viral vector manufacturing capacity and for a guided virtual tour of our facilities!
Because we are a one-stop shop, our goal is to be your partner from process development up to commercial products. This is why we are currently investing in the construction of a new building. This additional manufacturing facility will double our global manufacturing footprint and allow us to increase our capabilities to keep on reducing time to patients for your gene therapies.
Located in the South of Paris, across the street from the current facility, this new building is designed for large-scale clinical and commercial batches. With commissioning in 2023, it is designed to be certified (European Medicines Agency) EMA and Food and Drug Administration (FDA) compliant, as is the case for the existing facility.
Frequently Asked Questions (FAQs)
cGMP means current Good Manufacturing Practices.
The goal of the cGMP regulation, is to ensure pharmaceutical quality for human pharmaceuticals. Indeed, every consumer expect that each batch of medicines they take will meet quality standards, in order to be safe and effective. The cGMP regulation are guidelines to be followed to assure proper design, monitoring, and control of manufacturing processes and facilities. When adhering to the cGMP regulations, the manufacturer is assuring identity, strength, quality, and purity of drug products by adequate control manufacturing operations.
Compliance to cGMP is regulated by regulatory agencies such as the Food and Drug Administration (FDA) in the US, the European Medicines Agency (EMA) in Europe, the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan…
GMP stands for Good Manufacturing Practices and cGMP stands for current Good Manufacturing Practices.
Both GMP and cGMP are guaranting quality, but there is a distinction between the two just like the “c” suggests. The “c” is added to certify that every step utilized in manufacturing a product wasn’t only done under GMP guidelines but also that every step was finished within the most current manner available. GMP rules and regulations are constantly improving and updating with technology.