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25 September 2024 | News
With new manufacturing suites, 500L bioreactors, and enhanced fill-finish capabilities in Alachua, Florida, alongside expanded GMP quality control in Munich, Ascend fortifies its infrastructure to support gene therapy innovators across continents through 2025.
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Ascend Advanced Therapies (Ascend), a gene to GMP development partner, has confirmed multi-million-dollar investments supporting global infrastructure of the company. Expanded GMP suite capacity up to 500L scales and the addition of fill finish capacity are in process at the GMP flagship facility in Alachua, Florida. The Munich, Germany facility is also in the process of bolstering GMP quality control (QC) testing, analytical, and process development capacity to meet industry demand and serve cross continent innovators and therapeutic companies. The expansions are expected to run into 2025.
Existing space within the Alachua facility will feature new manufacturing suites and fill/finish capabilities. Bioreactors up to 500L will now be available, with the goal of larger formats in the future. Additional space has been allocated to build out temperature controlled GMP warehousing and process development labs with flexible operational space.
“There are both tangible and intangible assets that make a company want to work with a contract manufacturer. Our goal is to align these assets and deliver clients an exceptional experience, regardless of whether it is development projects or full clinical drug production,” Mike Stella, CEO at Ascend offered. “As our footprint grows, we will iterate over 2 decades of therapeutic AAV expertise into a connected global footprint with cutting-edge, enabling technologies, and analytics for our clients.”
Since inception, Ascend has differentiated the business with specialized gene therapy support for developers combining a small entrepreneurial, collaborative culture with an exceptional technology portfolio. Several recent hires have been made to strengthen the foundation of the company and meet growth goals. Registration of the EpyQ™ AAV production system has been completed globally, with more information coming about the proprietary split two plasmid transfection alternative.