Cell and Gene Therapy

Biogen and Ginkgo Bioworks Collaborate and License Agreement to Develop Novel Gene Therapy Manufacturing Platform

Biogen and Ginkgo Bioworks announced a partnership in gene therapy today. The companies aim to redefine the industry standard for manufacturing recombinant adeno-associated virus (AAV)-based vectors by working together.

Recombinant AAV-based vectors are extensively used in the development of novel gene therapies with the ability to cure neurological and neuromuscular diseases, as well as other conditions in a variety of therapeutic areas. Manufacturing is now time-consuming and expensive, making it difficult to develop therapies for diseases with high dosage requirements and large patient populations.

Ginkgo intends to address these issues by using its mammalian cell programming platform to increase the performance of AAV-producing plasmid vectors and cell lines, potentially accelerating Biogen's development of novel gene therapies.

“We believe that Ginkgo's unique combination of cell programming expertise, proprietary tools, and biological system awareness makes them a perfect collaborative partner to explore a broad range of design ideas to optimize constructs,” said Alphonse Galdes, Ph.D., Biogen's Head of Pharmaceutical Operations and Technology.“They share our goal of ensuring that approved therapies are not delayed due to manufacturing constraints and are available to patients all over the world.”

“We are delighted to partner with Biogen as they seek to develop treatments that can potentially delay, stop, or cure neurological and neurodegenerative diseases, as well as to improve the industry standard for AAV manufacturing,” said Jason Kelly, CEO of Ginkgo Bioworks. “Synthetic biology is utilizing the power of living cells to develop the next generation of therapeutics, including CAR-T, CRISPR, and gene therapies, which we hope would have a significant effect on the lives of many people.”

Biogen will have access to Ginkgo's proprietary cell programming platform and capabilities under the terms of the agreement. Ginkgo will use its bioengineering facilities and resources to improve Biogen's gene therapy manufacturing processes' AAV output titers. Ginkgo will receive a $5 million initial payment and will be eligible for milestone payments of up to $115 million if the partnership programs achieve certain research, development, and commercial milestones.

About Biogen
Our mission at Biogen is clear: we are neuroscience pioneers. Biogen discovers, develops, and delivers innovative therapies for people suffering from severe neurological and neurodegenerative diseases, as well as related therapeutic adjacencies, around the world. Biogen was founded in 1978 by Charles Weissmann, Heinz Schaller, Kenneth Murray, and Nobel prize winners Walter Gilbert and Phillip Sharp as one of the world's first major biotechnology firms. Biogen currently has the leading portfolio of medicines for the treatment of multiple sclerosis, is the first approved treatment for spinal muscular atrophy, commercializes biosimilars of advanced biologics, and is focused on advancing research programs in multiple sclerosis and neuroimmunology, Alzheimer's disease, and dementia, neuromuscular disorders, movement disorders, ophthalmology, and neuropsychiatry.

About Ginkgo Bioworks
Ginkgo is building a platform for program cells in the same way as we program machines. The platform is enabling the growth of biotechnology across a wide range of markets, from food and agriculture to industrial chemicals and pharmaceuticals. Ginkgo is also closely involved in a variety of COVID-19 response efforts, such as community testing, epidemiological tracing, vaccine development, and therapeutics discovery.

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