Yposkesi, the clinical and commercial viral vector manufacturing subsidiary for Cell and Gene Therapies (C>), under SK pharmteco, proudly announces the inauguration of its new 5,000 m2 (50,000 ft2) industrial bioproduction site for C> manufacturing. This expansion, valued at €60M ($65.3M), doubles Yposkesi’s cGMP manufacturing footprint to 10,000 m2 (100,000 ft2), addressing the pressing need for increased viral vector supply, the preferred gene delivery system for manufacturing C> products. The new facility allows Yposkesi to scale up production and serve clients in their journey from clinical to commercial batches, contributing to the advancement of personalized medicine for critical diseases and rare disorders.
Doubling Production Capacity: Meeting the Industry’s Demand
Viral vectors play a crucial role in the manufacturing of advanced Cell and Gene Therapies, which represent personalized forms of medicine for the treatment of critical diseases and rare disorders. By doubling its production capacity to 75 batches per year, Yposkesi significantly improves access for clients to high-quality viral vectors throughout the year. This increased capacity ensures that clients can readily scale up their C> projects, from early drug development to large-scale commercial manufacturing. The ribbon-cutting ceremony for the new facility was attended by esteemed guests, including Yposkesi CEO Alain Lamproye, SK pharmteco CEO Joerg Ahlgrimm, and Yeontae Kim, EVP Head of the Biotech Investment Center at SK Inc., along with clients, French government officials, and employees.
Enhanced Access to Viral Vector Manufacturing: A Step towards Better Patient Outcomes
Alain Lamproye, CEO of Yposkesi, expressed great pleasure and pride in the opening of the new viral vector manufacturing facility. The twin sites enable Yposkesi to keep up with increasing demand by producing larger quantities of C> products approved for commercialization. The state-of-the-art design of the facility facilitates efficient and cost-effective manufacturing of advanced therapies, making them more accessible to patients. By collaborating closely with clients, Yposkesi ensures that their C> pipelines and commitments are met, contributing to improved patient outcomes.
Strategic Location: The Genopole Campus
Yposkesi’s twin viral vector manufacturing sites are strategically located on the Genopole campus, the largest biotech cluster in France. The proximity of the facilities enables parallel production and optimized batch start schedules, maximizing the utilization of resources. The twin facility also strengthens Yposkesi’s business continuity plan by providing backup production and quality control capabilities, ensuring uninterrupted delivery for clients. Moreover, the facility complies with European and American current GMP guidelines, meeting stringent quality standards.
Meeting Market Demand: A Growing Industry
The investment of €60M ($65.3M) in the expansion of Yposkesi’s production capacity reflects the growing global viral vector manufacturing market. The market, estimated at $5.5 billion in 2023, is expected to reach $12.8 billion by 2028, with a compound annual growth rate (CAGR) of 18.2%. Factors such as the rising prevalence of target diseases and disorders, availability of drug development funding, and the effectiveness of viral vectors in gene delivery drive the demand for viral vector manufacturing capacity.
State-of-the-Art Facilities: Boosting Bioprocessing Capabilities
The new site, currently undergoing qualification, is scheduled to be fully operational by 2024. It is equipped to handle both Adeno Associated Virus (AAV) and Lentiviral Vector (LV) platforms. Notably, Yposkesi’s Lentisure™, a CAR T-cell platform designed for optimized yields, will be accommodated. The facility includes six Upstream Process (USP) clean rooms and two Downstream Process (DSP) clean rooms. With this expansion, Yposkesi’s bioreactor capacity triples from 2,000 L to 7,000 L, allowing for increased production volumes. The facility also features fill and finish capacities with semi-automated suites capable of processing 12,000 vials per year.
Commitment to Sustainability: Green Solutions Incorporated
Yposkesi, in line with SK pharmteco’s ESG initiatives, contracted CBI, a subsidiary of Vinci Construction France, as the general contractor for the project. Pharmaplan, an engineering service for the pharmaceutical industry, contributed to the building’s design. The construction process incorporated green solutions, including the appropriate management of installations to minimize energy consumption, use of renewable energies such as solar panels and electric vehicle charging stations, selection of energy-efficient equipment, and energy recovery to reduce the carbon footprint. Yposkesi’s commitment to sustainability extends beyond its manufacturing capabilities, aligning with global environmental goals.
Conclusion: Empowering Cell and Gene Therapies through Enhanced Manufacturing
Yposkesi’s new biomanufacturing site marks a significant milestone in the advancement of Cell and Gene Therapies. With the doubling of its viral vector production capacity, Yposkesi is primed to meet the increasing demand for these advanced therapies. The state-of-the-art facilities, strategic location, and commitment to sustainability position Yposkesi as a leading player in the viral vector manufacturing landscape. As the biopharma industry strives to develop innovative solutions for critical diseases and rare disorders, Yposkesi’s expanded capabilities will play a vital role in accelerating time to market and improving patient outcomes. Through continuous investment in bioprocessing innovation, Yposkesi remains dedicated to delivering high-quality gene-modified cell therapies and in vivo gene therapy projects within a comprehensive service environment.
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