Cobra Biologics
Developing an industrial biologics manufacturing platform
Development of an industrial manufacturing platform for adeno-associated virus (AAV) production
Gene therapy is a rapidly growing therapeutic area, with AAV being one of the main platforms being developed for commercialisation. The production of well characterised, high quality AAV vectors is critical for the success of gene therapy. This will be achieved by developing platform AAV manufacturing processes that are robust and scalable.
This project addresses the key barriers facing routine production of AAV by focusing on the development of a scalable platform process. The project had two partners; CPI and Cobra Biologics, and was supported by funding from Innovate UK through the UK Government’s developing regenerative medicines and cell therapies initiative.
Achievements
Inputs
- Provided open access to CPI’s state-of-the-art facilities
- Shared expert technical and industrial knowledge through collaborative development projects
- Provided project management and business support services
- Expertise in biomanufacture of gene therapy components
Outputs
- Advanced analytical tool kit consisting of conventional and high throughput techniques to support AAV in-process development and final product quality
- Robust 2D and 3D upstream process for AAV vector production at various scales through to manufacture
- Robust downstream process with contaminant clearance for AAV vector purification at various scales
- Quality by design (QBD) mapping for upstream and downstream processes of AAV manufacture
Outcomes
- Robust work flows and methods to support process development through to manufacture of AAV
- Optimising processes to reduce production costs of AAV
- Exemplification of collaborative project approach which would be applicable to other gene therapies and viral vaccines
- Identification of areas to target future development of AAV manufacture
![](https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/virus.jpg?w=1920&h=1080&q=60&fm=jpg&fit=crop&dm=1559216073&s=41c91c796a791613ec931441a92f54b8 1920w, https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/virus.jpg?w=1120&h=630&q=60&fm=jpg&fit=crop&dm=1559216073&s=483334679ba8fb37d4ac30f8474d4ff1 1120w, https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/virus.jpg?w=800&h=450&q=60&fm=jpg&fit=crop&dm=1559216073&s=29eed32545c51ae0f0488b3dd7f9f682 800w, https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/virus.jpg?w=1600&h=900&q=45&fm=jpg&fit=crop&dm=1559216073&s=c57dbf4df0a551e8686c0846ff8f62e3 1600w, https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/virus.jpg?w=480&h=270&q=60&fm=jpg&fit=crop&dm=1559216073&s=74cabbda5b29c5b702453ee430d5ea98 480w, https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/virus.jpg?w=960&h=540&q=45&fm=jpg&fit=crop&dm=1559216073&s=1cca3ab3420371a7bb3f4c01c0ef7157 960w)
The challenge
The gene therapy market is expanding extremely rapidly and set to reach $10 billion by 2025. The challenges facing industry include producing increasing amounts of high quality material to meet the rising demand of these therapies to address unmet medical need. Scalable, robust processes for multiple AAV serotypes meeting regulatory requirements are essential to growing this therapeutic area.
How CPI helped
The project aimed to develop a scalable manufacturing platform for selected AAV serotypes. CPI’s expertise and assets played a key role in the following areas:
- Optimised transfection and cell growth to achieve high titre vector production in both 2D and 3D cultures
- Designed and optimised novel work flows to support the downstream processing of AAV vectors
- Development of a high throughput analytical toolbox
Related
Technologies
Markets
![](https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/biotherapeutics-viral-image.jpg?w=1920&h=1080&q=60&fm=jpg&fit=crop&dm=1559218249&s=a23fa532b450da2edf78da6a8553ada4 1920w, https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/biotherapeutics-viral-image.jpg?w=1120&h=630&q=60&fm=jpg&fit=crop&dm=1559218249&s=a690ef33579641cc8596aab95675bf46 1120w, https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/biotherapeutics-viral-image.jpg?w=800&h=450&q=60&fm=jpg&fit=crop&dm=1559218249&s=87be3239db9e4cc1257df1ee5d4e87f8 800w, https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/biotherapeutics-viral-image.jpg?w=1600&h=900&q=45&fm=jpg&fit=crop&dm=1559218249&s=a85211df4b2464c6c41abed7b5438097 1600w, https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/biotherapeutics-viral-image.jpg?w=480&h=270&q=60&fm=jpg&fit=crop&dm=1559218249&s=28a488212ebb3021bbd606719acfd7d2 480w, https://optimise2.assets-servd.host/smart-hoopoe/production/content/images/biotherapeutics-viral-image.jpg?w=960&h=540&q=45&fm=jpg&fit=crop&dm=1559218249&s=4762e69849a8512e12278f44708b5988 960w)