The French company, which is focused on cell and gene therapy (CGT) viral vector manufacturing, is partnering on 20 projects globally, reported Alain Lamproye, CEO of Yposkesi.
“We have also just signed a contract with a big US pharma player. Unfortunately, we are not yet able to disclose the name of that new client.”
Yposkesi is in the process of expanding its plant in Corbeil-Essonnes, south of Paris as well, to the tune of around €60m (US$62.3m). There will be two additional manufacturing suites, each of which will be equipped with two bioreactors of 1,000L scale.
The expansion is aimed at optimizing throughput. Those suites will deliver 40 batches per year. “That is in the high-end of the range,” noted the executive when asked for a comparison with the industry standard.
The build got underway in May 2021: “All of the construction, the installation of the utilities as well as the process equipment will be completed in February next year. We will then proceed with the qualification phase, a process that will take around eight to nine months. The plant will then be inspected by the French health authority, by the end of next year."
So the facility should be operational, producing and certifying commercial GMP batches, by Q1 2024, he added.
“The expanded facility will allow us to support our clients and ongoing projects from the very early phase, up to the manufacturing of large-scale batches, possibly, and hopefully, commercial batches. We have a couple of projects today that might end up in this facility in 2024 or 2025, depending, of course, on their success in clinical trials,” said Lamproye.
With more than 1,000 cell and gene therapies currently in development and 50–75 therapies expected to be approved in the US by 2030, viral vector manufacturing is rapidly expanding to address the need for the commercial production of these therapies.
Yposkesi has developed two platforms for AAV and lentiviral vector manufacturing. Both have been proven over the years, according to the company, allowing it to generate high yields.
The contract development and manufacturing organization (CDMO) outlined how it leverages 'gold-standard' equipment and reagents to maximize cost-effectiveness and reduce time to market. Proprietary ‘optimized’ transfection reagents and high-producer cell lines are used on the platforms.
Industry expertise will be critical in terms of attracting new clients. Mindful of that, Yposkesi made key hires earlier this year, within its leadership team. In July, it announced the appointment of Louis-Marie de Montgrand, formerly with Sanofi, GSK, Thermo Fisher Scientific, and Novasep, as its chief operating officer, and it recruited Christophe Cambouris for the post of chief commercial officer. He has with more than 20 years of business experience in the CGT sector.
“We are also harvesting the fruits of our successful integration into SK pharmteco [which is a subsidiary of SK Inc] and we are exploring potential synergies with the Center for Breakthrough Medicines (CBM),” continued the CEO. SK took a minority stake in that Philadelphia-based CDMO last year.
Raw material shortages
The COVID-19 pandemic, of course, created numerous challenges in relation to raw material supply, with Yposkesi directing a lot of energy into the management of such issues.
“Before the onset of the pandemic, the supply chain was already under pressure, particularly for critical raw materials such as plasmids. Those issues were [accentuated] by the COVID-19 crisis - we saw a lot more pressure on certain key consumables. The way we tried to address the challenge was [to diversify] our supply base. And this is where our collaboration with CBM is useful as it has additional capacity for plasmids.”
The global shortage in pipette tips, again pandemic related, due to their expanded use in PCR test kits, was also quite an alarming development for the CDMO player. “That is solved now but it caused us a lot of stress and tension, in terms of trying to supply our labs and production suites on time.”
The limited supply of bioreactor bags created another bottleneck: “We were lucky, as before the pandemic, we had some stock, some inventory available, which certainly helped us keep the plant up and running." In summary, while extremely stressful, the company was able to manage that supply chain challenge, again through the identification of alternative suppliers, he said.
Though pandemic-linked raw material shortages are, to a large extent, remedied, the supply of key consumables could potentially be under threat again, given current energy prices, he warned.
Growth prospects
Lamproye remains optimistic about the potential of the CGT sector despite some of the setbacks seen in gene therapy clinical trials in the past year, and consequent decisions by companies to prioritize their product pipeline. “The [change in the investment outlook] may have also forced companies to be more realistic in terms of the number of products they could develop, in parallel, which has had the effect of somewhat slowing down the CDMO market as well. But we believe the sector is extremely promising in terms of growth – the FDA just approved the most expensive drug ever, a $3.5m per dose gene therapy.”
Looking at the number of mergers and acquisitions and expansions in the CDMO sector, it has definitely become a more competitive arena, he noted.
He agreed that the nature of the CDMO and pharma owner relationship has evolved, it has become a partnership, combining key strengths, with, perhaps, the two parties undertaking co-development projects. “It is about ensuring full transparency when working with customers. There is no advantage in hiding failures or other issues.”