Biogen and Ginkgo Bioworks Announce Collaboration Develop Novel Gene Therapy Manufacturing Platform

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Alphonse Galdes

CAMBRIDGE, Mass. and BOSTON– Biogen and Ginkgo Bioworks today announced a gene therapy collaboration. Together, the companies aim to redefine the industry standard for manufacturing recombinant adeno-associated virus (AAV)-based vectors.

Recombinant AAV-based vectors are widely used to develop innovative gene therapies and have the potential to treat certain neurological and neuromuscular diseases as well as other conditions across multiple therapeutic areas.

Currently, manufacturing is time-consuming and expensive making it difficult to develop therapies for diseases with high dose needs and with large patient populations. Ginkgo seeks to solve these challenges by applying its mammalian cell programming platform, with the aim to improve the efficiency of AAV-producing plasmid vectors and cell lines, which could accelerate Biogen’s development of novel gene therapies.

“We believe that Ginkgo’s unique combination of cell programming expertise, proprietary tools and knowledge of biological systems make them an ideal collaboration partner to explore a large number of design ideas with the goal of optimizing constructs,” said Alphonse Galdes, Ph.D., Head of Pharmaceutical Operations and Technology at Biogen. “They share our goal of ensuring approved therapies are not delayed by manufacturing constraints and are available to patients worldwide.”

“We are excited to collaborate with Biogen as they aim to develop treatments that may potentially slow, halt or cure neurological and neurodegenerative diseases and seek to enhance the industry standard for AAV manufacturing,” said Jason Kelly, CEO of Ginkgo Bioworks.

“Synthetic biology is leveraging the power of living cells to develop the next generation of therapeutics, everything from CAR-T, to CRISPR and gene therapies, which we believe will have a material impact on the lives of many.”

Under the terms of the agreement, Biogen will receive access to Ginkgo’s proprietary cell programming platform and capabilities. Ginkgo will utilize its bioengineering facilities and resources with the aim of enhancing the AAV production titers of Biogen’s gene therapy manufacturing processes.

Ginkgo will receive an upfront payment of $5 million and is eligible for milestone payments up to an additional $115 million should the collaboration programs achieve certain research, developmental and commercial milestones.