Thursday 9 June 2022, Amsterdam
Laboratory technicians operating in an upstream GMP manufacturing cleanroom of the new state-of-the-art plants of Exothera.
Exothera S.A., a leading CDMO that specializes in the development and manufacture of viral vectors for vaccines and gene therapies, has developed and is continuing improving the exoREADY platform for accelerated viral vector manufacture. This fully integrated platform will ensure faster, more cost-effective production of viral vector-based therapeutics (for gene therapy, vaccines, and oncolytic viruses for cancer treatment) at scale.
Viral vector-based cell and gene therapies are increasingly being applied to the treatment of a wider range of health conditions such as chronic diseases, cancers, and autoimmune diseases. While the market is growing rapidly, the industry is struggling to deliver affordable therapies quickly because development and manufacturing processes are complex. Innovative biotechs are being slowed down because they have to select and assemble all the complex elements required for the development and manufacture of their therapies.
Exothera is overcoming these limitations by introducing exoREADY, a plug-and-play viral vector platform where all the steps in the production process will be assembled and optimized so that the system is ready-to-use. The platform will significantly shorten production lead times, improve manufacturing process robustness, and have a significant impact on cost per dose.
The exoREADY platform's objective is to provide an off-the-shelf solution for transient expression for both adeno-associated virus (AAV) and lentivirus (LV) compatible with adherent and suspension culture based on an optimized HEK-293 cell line. exoREADY users will also access pre-optimized downstream purification processes, dedicated quality control protocol and an analytical testing tool kit that can address all the steps required for the manufacture of complex advanced therapies in a fast, efficient, and lower cost manner. Exothera is developing the platform so that only a few parameters need to be fine-tuned to be able to lock in the process quickly enabling biotherapeutic companies to scale production rapidly.
Emilie Gateau, Platform Development Manager at Exothera
: "Large scale viral vector-based therapeutics manufacturing is still challenging, and our goal is to significantly streamline the process by providing an all-in-one platform for commercial scale manufacturing which offers a fast, affordable solution, from cell line selection to drug substance delivery".
"We are very grateful for the support and trust of Wallonia. Their financing is helping accelerate the optimization of the exoREADY platform, thereby providing the industrialization tools cell and gene therapy product developers need to become available to all,"
said Thibault Jonckheere, Chief Executive Officer at Exothera
The exoREADY platform comes as an additional disruptive asset for Exothera. The company recently extended its GMP facility in Jumet (Belgium) to 8,600 m² (92,570 ft²). The expansion allows Exothera to become one of the largest viral vector manufacturing facilities in Europe, only two years after it was founded.
Source: Exothera S.A.
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