Biopharma solution provider Single Use Support announces an order from Genezen, a cell and gene therapy Contract Development and Manufacturing Organization (CDMO).
The Indianapolis-based CDMO has ordered RoSS.FILL CGT to fill lentiviral vectors into small single-use bags. Specially designed for cell and gene therapies, RoSS.FILL CGT is an automated cGMP-compliant filling and filtration platform to dispense small to medium sized volumes of highly valuable drug substances into multiple small single use bags. The technology will be supplied to Genezen’s facility by the end of 2021.
The CEOs of the Austrian-based process solution provider Single Use Support, Thomas Wurm and Johannes Kirchmair, are delighted to secure the deal with Genezen. “We are proud to be supporting Genezen with their automated filling manufacturing process and to be part of their ongoing major growth”, said Wurm referring to the current expansion of the CDMO in Indianapolis. “We are both fast-paced companies with a high degree of innovation – it will be a great match”, Kirchmair adds.
Commenting on the announcement, newly appointed Genezen CEO, Ray Kaczmarek added: “It’s an exciting time to announce this agreement with SUSupport as Genezen makes significant strides towards the completion of our new multiphase 75,000+ square foot cGMP lentiviral and retroviral vector production facility in early 2022. Our facility will deliver cGMP-compliant viral vector production and a full suite of complementary process development capabilities to support commercial readiness.”
Kaczmarek is certain of a great partnership: “Having partners such as Single Use Support in place will be one of many essential components as we scale our operations to deliver high-quality programs and vector production services to our clients.”
Growing expertise in cell and gene therapies
End-to-end process solutions from Single Use Support have proven to be successful at laboratory but also commercial scale in the production of bulk drug substance. Its involvement in the production of COVID-19 vaccines and mAbs demonstrated that the industry relies on its portfolio ranging from protection of single-use bags, filling & draining, freezing & thawing, cold storage, and shipping. The purchase from Genezen demonstrates once again the technologies’ flexibility and its applicability to different areas in Biopharma. Cell & gene therapies and upstream seed train intensification are such fields where customers can use solutions for different batch sizes and volumes while remaining independent from any single use bag or bottle.
Single Use Support GmbH – The Company
What began with a vision in a garage quickly developed into a global technology company. Single Use Support GmbH was founded in 2016 by Johannes Kirchmair and Thomas Wurm. The company specializes in the development and production of mechatronic systems for the pharmaceutical industry and develops solutions for a 100% safe liquid logistics process. Single Use Support offers innovative product solutions that enable high-quality, essential medicines to be transported safely, sterile and frozen around the globe in so-called single-use bags. Customers of the innovative Tyrolean company with headquarters in Kufstein are well-known pharmaceutical companies in Europe, Asia and America. Single Use Support has over 100 employees and will exceed an annual turnover of EUR 100 million in 2021.
Genezen – The Company
Founded in Indianapolis in 2014, Genezen is focused on supporting the demands of the current and future gene and cell therapy manufacturing market worldwide — making viral vector production accessible to both early-stage, growth-oriented companies and established industry leaders. Genezen offers early-phase process development, GMP lentiviral vector production, GMP retroviral vector production, and analytical testing services, building on the company's expansive knowledge and experience in the industry and working with the nation's leading institutions. For more information, or to learn more about services offered in Genezen's new cGMP facility, please visit www.genezen.com.