cGMP manufacturing of clinical & commercial batches
cGMP manufacturing processes with high-quality standards
According to the Food and Drug Administration (FDA), “cGMPs provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities. Adherence to the cGMP regulations assures the identity, strength, quality, and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations.“.
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!
Manufacture with our platforms
Developed over the years, Yposkesi is proudly manufacturing lentivirus and AAVs with streamlined and optimized platforms:
Plug-and-Play, scalable, with high productivity, and developed with analytical methods, LentiSure™ and our AAV platform can help your product be in the market faster in a cost-effective way.
Both of Yposkesi’s platforms are proven and have already manufactured, with the help of our experts, more than 215 viral vector batches. Among those 215 batches produced, 70 are clinical batches of viral vectors that supplied clinical trials in Europe and in the United States.
Because we are a full-service CDMO, our goal is to be your partner from process development up to commercial products. Therefore, we are currently investing in the construction of a new building extension. 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 bio-manufacturing building is designed for large-scale clinical and commercial batches according to cGMP requirements. With commissioning in Q1 2024, 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 expects that each batch of medicines they take will meet quality standards, in order to be safe and effective. The cGMP regulation is 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 the identity, strength, quality, and purity of drug products by adequate control of manufacturing operations.
Compliance with 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 guaranteeing 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.
Of course, joining the SK pharmteco company in 2021 allowed us to have access to SK pharmteco’s commercial and regulatory expertise and 80-year history in the CDMO industry. Demonstrating a culture of strong compliance through successful regulatory inspections, SK pharmteco’s facilities have been successfully audited by several regulatory authorities: Food and Drug Administration (FDA), Agence Nationale de sécurité du médicament et des produits de santé (ANSM), Health Canada, European Medicines Agency (EMA), PMDA Japan…
At Yposkesi, we have a dedicated team to make sure that we always follow the last version of the regulatory guidelines. The regulatory affairs team is constantly following advancements on this topic. Yposkesi is working closely with the regulatory agencies to make sure that our processes, systems, methods, and facilities are following cGMP regulations. Always having the patient in mind, our ultimate goal is to be on top of our game regarding quality standards. Contact us to learn more!
Quality is definitely a hot topic when it comes to viral vector manufacturing and more generally to drug product development and manufacturing. When you are developing a medicinal product, there are a few steps for it, and not all the steps require you to follow the cGMP guidelines. However, if the goal is to propose the drug in the market for patients, those guidelines will need to be followed at some point. This is why it is important to partner with an experienced CDMO that can manufacture viral vectors with high-quality standards and that complies with cGMP.
First, it is important to note that regulatory agencies are not the same in Europe and the US. In Europe, the European Medicines Agency (EMA) guidelines need to be followed and in the US the Food and Drug Administration (FDA) needs to be followed. Both agencies have their specificities and requirements, so when developing the product(s), it is important to apprehend and anticipate in which agency the clinical trial/marketing authorization application will be filed.
There are indeed some contrasts in the regulatory pathways in the US and Europe. For example, when it comes to:
The ATMPs definition and their sub-classification:
- In Europe, there are three major groups:
- Gene therapy medicines
- Somatic-cell therapy medicines
- Tissue-engineered medicines
- While in the US, there are two groups:
- Gene therapy products;
- Cellular products;
The application to run a clinical trial:
- In Europe, the dossier is called IMPD for Investigational Medicinal Product Dossier and is only valid for one clinical trial. The IMPD also needs to be validated by each concerned country in Europe and since the beginning of 2023, this dossier is submitted to the CTIS (Clinical Trials Information System) Europe’s unique platform.
- While in the US, the application is called an IND for Investigational New Drug. The IND application provides unrestricted access during the development program and can be updated through amendments.
Even though it exists some regulations differences between the US and Europe, the requirements regarding drug product quality are harmonized by a joint authority. Indeed, the International Conference of Harmonization (ICH) is harmonizing the requirements for dossier submissions and cGMP.
The FDA and EMA are the mains ones, but more regulatory agencies exist: Agence Nationale de sécurité du médicament et des produits de santé (ANSM) in France, Health Canada, PMDA Japan…
The pharmaceutical company needs to follow the local cGMP regulations when developing a drug product if they want to market the product in this continent.