Yposkesi’s new biomanufacturing site: interview with our Chief Operational Officer

In today’s article, we are interviewing Louis-Marie de Montgrand, Chief Operational Officer at Yposkesi, an SK pharmteco company, to tell us about the new biomanufacturing site that just completed construction and is under qualification in Corbeil-Essonnes (South of Paris, France).

Can you tell us more about Yposkesi’s new biomanufacturing site construction and where we stand?

The construction of this new state-of-the-art facility commenced two years ago and is a very impressive sight. Click here to watch the timelapse video of the building’s construction.

The construction is completed, and the building and its equipment are in the process of qualification, we are currently ensuring everything is operational to begin the manufacturing of AAVs and Lentivirus in 2024.

Overall, the construction of this facility required a significant investment of time, money, expertise, and foresight, which was crucial to advance the field of cell and gene therapies (C&GT) and improve patient outcomes not just for the near future but for years to come.

With this new resource, Yposkesi will create around a hundred jobs and be in the top 3 of European C&GT Contract Development and Manufacturing Organizations (CDMOs), remaining number 1 in France.

How was the building designed?

Yposkesi’s new building was designed not only to ensure production at the highest safety standards and quality of viral vectors, equipped with gold-standard materials and technology but also has factored in the environmental conditions of our planet. The new facility is designed to be compliant with both European and American current GMP guidelines.

This new resource is designed with a total of six Upstream Process (USP) clean rooms and two Downstream Process (DSP) clean rooms among two new production lines, the latter mirroring each other. The USP and DSP clean rooms were designed with separate control areas to segregate each stage of the viral vector manufacturing process and allow us to produce several batches at the same time. The USP rooms are equipped with several scales’ bioreactors allowing us to triple our installed capacity.

On top of having strict controls in place to prevent contamination, the building is equipped with air and water systems that meet cGMP requirements, the new facility has a dedicated waste flow that is completely independent of the drug substance flow, so there is no cross-contamination possible, and the environment is completely controlled.

And of course, our experts are trained to follow strict protocols to minimize the risk of errors and contamination.

A viral vector manufacturing building is a critical component in the safe and effective production of viral vectors for use in cell and gene therapies, this is why we have designed and developed this new structure with patients at the forefront of our minds.

Our fill and finish capacities, with semi-automated suites for a total of 12,000 vials per year remain at Yposkesi’s first facility, located next to the new facility.

You mentioned that you considered the environment while designing the new facility, can you elaborate on that matter?

Optimizing energy consumption in an industrial building is of vital importance. Indeed, the pharmaceutical industry is known to be very energy-intensive, with high consumption of electricity, natural gas, and oil. Energy costs can therefore represent a significant part of the production costs for a company like Yposkesi.

To deal with this challenge, the project team left no stone unturned during the design process to implement innovative greener solutions to optimize the energy performance of the building and the manufacturing process. Among the many solutions implemented, we can cite 4 main areas of energy saving:

• The optimization of consumption through appropriate management of installations and reduction of losses. Unfortunately, we consume huge volumes of energy, which comes at a great cost, a series of measures were taken to optimize our consumption. For example, the implementation of automated lighting, also the installation of a white roof waterproofing coating, which reduces the heat input by radiation.
• The use of renewable energies: implementing solutions that make it possible to significantly reduce carbon footprint while ensuring high energy efficiency. For instance, we installed solar panels on the roof for heating water and charging stations for electric vehicles.
• The selection of more energy-efficient equipment especially for manufacturing processes and production systems. Including the installation of low-consumption lighting (LED), and low-consumption motors on fluid pumps, fans, or refrigeration units.
• Energy recovery: we have reduced our carbon footprint by harnessing otherwise wasted heat to recycle it back into other aspects of our operations.

In conclusion, energy savings are a major benefit not only for Yposkesi but also for the environment. By implementing effective strategies and technologies to reduce energy consumption, Yposkesi can not only achieve financial savings and thus gain competitiveness, but also contribute to the protection of the environment by becoming a player in the energy transition.

What is the goal behind this building?

With this new biomanufacturing site, which will be operational at the beginning of 2024, Yposkesi will double its production surface, going from 5,000 m2 to 10,000 m2. The goal behind that investment is to support customers’ clinical trials in several therapeutic indications including those requiring high doses and high product volumes, hence improving patient outcomes.

Associated with our expertise, our biomanufacturing lines are increasing efficiency at each manufacturing step, optimizing and reducing the complexity across unit operations.

In our industry, flexibility is key, but consistency and safety are paramount, with this second biomanufacturing site, Yposkesi is strengthening its leadership position by creating a business continuity plan with back-up production, and quality control, to safeguard delivery guarantees for our clients.

With the combination of decades of scientific know-how and this new manufacturing facility for commercial application, Yposkesi is also consolidating its LentiSure™ platform to improve our cost, optimize state-of-the-art manufacturing practices and be able to provide Drug Substances and Drug Products more accessible and affordable!