Biogen and Ginkgo Bioworks have partnered to develop a next-generation AAV production platform to accelerate Biogen’s gene therapy drug development efforts.
Biogen and Ginkgo Bioworks, a US-based bioengineering company, have entered into a gene therapy collaboration worth up to $120 million, under which they will develop a next-generation manufacturing platform to product recombinant adeno-associated virus (AAV)-based vectors, the companies stated in a May 21, 2021 press release.
Under the agreement, Biogen will receive access to Ginkgo’s proprietary cell programming platform and capabilities, and Ginkgo will receive an upfront payment of $5 million as well as eligibility for milestone payments up to an additional $115 million should the collaboration programs achieve certain research, developmental, and commercial milestones. Ginkgo will use its bioengineering facilities and resources to enhance the AAV production titers of Biogen’s gene therapy manufacturing processes.
Currently, manufacturing of recombinant AAV-based vectors 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 and aims to improve the efficiency of AAV-producing plasmid vectors and cell lines, which could accelerate Biogen’s development of novel gene therapies, Ginkgo said in the company press release.
“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, PhD, head of Pharmaceutical Operations and Technology at Biogen, in the press release. “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, in the press release. “Synthetic biology is leveraging the power of living cells to develop the next generation of therapeutics, everything from CAR-T [chimeric antigen receptor T-cell] to CRISPR [clustered regularly interspaced short palindromic repeats] and gene therapies, which we believe will have a material impact on the lives of many.”
Source: Biogen
Understanding the Variability in Bioburden Test Results in Biomanufacturing
May 7th 2025This article explores the impact of test volume, microbial distribution, and dilution errors on bioburden testing variability. It presents statistical approaches to estimate percentage error and discusses strategies to optimize microbial enumeration techniques in biopharmaceutical quality control.
Drug Solutions Podcast: A Closer Look at mRNA in Oncology and Vaccines
April 30th 2024In this episode fo the Drug Solutions Podcast, etherna’s vice-president of Technology and Innovation, Stefaan De Koker, discusses the merits and challenges of using mRNA as the foundation for therapeutics in oncology as well as for vaccines.
Trump Directs FDA, EPA to Reduce Regulatory Barriers to Domestic Pharma Manufacturing
May 7th 2025The White House is instructing FDA to increase fees for and inspections of foreign drug manufacturing plants and reduce the time required to approve such sites that will be newly constructed in the US.
Intertek to Expand UK GMP Facility with 6000 Square Feet of Lab and Office Space
May 7th 2025The company said the expansion is in response to globally rising demand for inhaled biologics, which offer distinct advantages in route of administration, but can be challenging products for developers.