Bankrupt Introgen reborn as CMO
Introgen filed for bankruptcy after the US Food and Drug Administration (FDA) rejected its application for Advexin (contusugene ladenovec). The company had already established a CMO business and this has been acquired by private equity investors that have formed Vivante.
Following the acquisition Vivante has good manufacturing practice (GMP) facilities and supporting quality laboratories, process and production equipment quality systems and other related assets.
Introgen used this infrastructure to produce adenovirus-based delivery systems and, in the almost 15 years it was operational, its staff gained considerable experience in the field, leading to the development of its adenoviral reference material.
The company also made extensive use of disposable systems that it believes allowed it to produce biologics in a more cost-effective manner.
Importantly for Vivante the asset purchase includes the former Introgen technical staff and management that gained this experience. David Enloe, former CEO and first employee of Introgen, will lead Vivante and is optimistic about the company’s future as a biologics CMO.
Capacity at Vivante
Vivante believes it has flexible, disposable technology-dependent, scalable GMP production capabilities that will be attractive to clients. Furthermore, it has the skills to scale up early stage, lab-grade production for clinical trials and commercial manufacture.
The company will also provide process development and optimisation, quality control analytical testing, on- and off-site GMP storage and distribution to clinical trial sites.
Both the development and manufacturing services will draw on the patents, proprietary quality and validation systems and GMP knowledge that Introgen. Vivante claims it already has contracts in place.
