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The new cell-line producing platform enables fully scalable production of high-performance adeno-associated virus vectors.
On April 28, 2020, Cevec Pharmaceuticals announced the launch of the ELEVECTA platform, a technology that enables the large-scale manufacture of adeno-associated virus (AAV) vectors by producing fully stable producer cell lines. The technology is paten protected and is now commercially available for gene therapy programs in late research stages as well as all clinical phases.
The ELEVECTA technology takes a unique approach based on producer cell lines, which have all the necessary elements for AAV production stably integrated in one cell. Up to now, manufacturing of AAV-the most widely used vector for in-vivo gene therapy-has required expensive transfection reagents and cGMP-grade plasmids. ELEVECTA overcomes these limitations and enables efficient, high-performance AAV production from one cell line in consistent quality. The technology can easily be implemented in bioprocess development and large-scale GMP manufacturing facilities running standard suspension bioreactor equipment widely used in industry for monoclonal antibody and recombinant protein production, Cevec said in a press release.
The technology works for any combination of serotype-specific capsid and therapeutic gene of interest. The stable integration of these components into the cell results in cell lines designed to produce highly functional AAV vectors. Custom-made ELEVECTA producer cell lines are available as research cell banks or as fully tested cGMP master cell banks for manufacturing of clinical and commercial material.
“The launch of ELEVECTA forms a milestone on the way into a new era of viral vector manufacturing as it provides a solution for one of the major challenges in gene therapy development. By closing the production gap and providing the necessary quantities of viral vectors, it paves the way to address more common indications such as Alzheimer's, Parkinson’s, or rheumatoid arthritis as well as therapies that require larger doses,” said Nicole Faust, CEO of Cevec, in the press release. “With this launch, we provide pharmaceutical and biotechnology companies with the opportunity to benefit right from the beginning from what we believe is the future for viral vector production. The superior features in terms of scalability, production efficiency, and robustness of our stable producer cell lines position [Cevec] at the leading edge in the rapidly growing field of gene therapy vector manufacturing.”
Source: Cevec Pharmaceuticals