Alain Lamproye, executive chairman of that gene and cell therapy contract development and manufacturing organization (CDMO), said the additional plant in Corbeil-Essonnes, south of Paris, will be operational by Q4 2023.
The new facility is set to add 5,000m2 of manufacturing space to Yposkesi’s current capacity.
The plant will house several 1,000L scale bioreactors, and multiple suites, which will be used for the production of lentiviral and adeno-associated virus vectors, in conformance with EU and US cGMP regulation.
“The new manufacturing plant will enable us to support our clients and projects from the very early phase where we optimize or develop a manufacturing process, up to when the project and the product is in the late phase clinical trials or even at the market approval [stage].
“And there is sufficient space to further expand this facility in the future.”
SK Inc. became the majority shareholder of Yposkesi in March 2021, when it acquired a 70% stake in the company. Yposkesi is a SK pharmteco company, which is a subsidiary of SK Inc.
That investment has made a huge difference, Lamproye told us: “The past few months have seen the integration of Yposkesi into this global operation. We have already started to leverage SK’s commercial network and we have been engaging with its teams in multiple areas such as operational excellence.”
Yposkesi can also tap into SK Pharmteco’s extensive knowledge around manufacturing approved molecules, even if that relates to small molecules. “From a quality management system, from a regulatory compliance point of view, we can benefit significantly from that expertise.”
The acquisition is a win-win for both parties, though.
In terms of the background to that deal, summer 2020 saw Yposkesi’s shareholders take a decision to not go down the venture capital route but to seek out an industrial partner instead in terms of support for expanding he business. They recognized that an entity with deep expertise in commercial manufacturing would serve it better that VC input, given the increasingly competitive landscape the CDMO found itself in, explained Lamproye.
Meanwhile, SK Pharmteco, originally an CDMO focusing only on small molecules, was looking to invest in biologics, in a structure with a clear focus on cell and gene therapy; it wanted to acquire a business with manufacturing activities, a project pipeline and expertise. It found that in Yposkesi.
SK recently took a minority stake in the Philadelphia-based, Center for Breakthrough Medicines (CBM), to further bolster its CDMO services and its footprint. “Being part of such a global organization is really exciting for Yposkesi,” commented Lamproye.
Looking at current challenges faced by CGT focused CDMOs, the expectation today is that the number of gene therapy products reaching the market will increase significantly in the coming years, and, as such, the customer wants its CDMO partner to have the right expertise, to have a clear view on the CMC strategy required to push a product through the different clinical stages, and the ability to deliver commercial batches, continued Lamproye.
“There is a need to instill confidence in the customer that the expertise is there and that there will be no major roadblocks during the clinical development of the product.”
Founded in 2016 as an industrial spin out from AFM-Généthon, a research foundation focused on genomic solutions for the treatment of rare diseases, with extensive bioprocessing expertise, Yposkesi believes that being able to leverage the technology the foundation developed over 30 years places it in a strong position on two fronts: it has a high yielding process for AAV manufacturing but also a strong process for suspension manufacturing of lentiviral vectors, which is becoming increasingly prevalent.
“It is clear that companies are moving from an adherent to a suspension based process because it is more suited to being scaled up. Even companies developing CAR-T cells, where they need a vector, essentially a lentiviral vector to transduce the T cells, we see that they also want a suspension based process, [a demand that is] often driven by regulatory considerations,” remarked Lamproye.
Adherent based manufacturing process tends to be performed using fetal bovine serum (FBS) – that may pose safety, consistency, and ultimately, regulatory challenges.
“The suspension manufacturing process eliminates the need for serum - our suspension platform relies on a chemically defined cell culture medium, which removes the contamination risk [to a large extent].
Process yield innovation
Yposkesi, he continued, has several innovation projects on the go, and it has been investing heavily in the area of process yield optimization.
“Improving process yields means decreasing manufacturing costs and it means potential and significant impact on pricing. Transfection is one area in which we are working actively, and we are testing different transfection agents.”
The CDMO, he said, is partnering on 16 client projects currently, initiatives that reflect its diverse customer base, from one of the top three pharma companies in the world to startup companies with just a few employees where most activities are sub-contracted, firms located both in Europe and the US.
“We have projects in clinical development where we have started to discuss with the clients about the use and their potential interest in our new manufacturing facility. We will see, obviously, how the business will develop over the next two to three years and whether there is a need to further expand [manufacturing capacity].”