Continuous gene therapy production targeted in UK collaboration

Cobra Biologics and the Cell and Gene Therapy (CGT) Catapult have teamed with Pall to explore continuous manufacturing of gene therapies. The project builds on a concurrent collaboration which looks to reduce the cost of adeno-associated virus (AAV) vectors.

The collaboration received a £1.5 million ($1.9 million) shared grant from Innovate UK, the United Kingdom’s innovation agency, to investigate continuous manufacturing of adeno-associated virus (AAV) for gene therapy applications.

“The project is a joint collaboration between Cobra, Pall and the Cell and Gene Therapy Catapult,” Peter Coleman, CEO of contract development and manufacturing organization (CDMO) Cobra Biologics told BioProcess Insider.

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“Each party bring their own expertise. The CGT Catapult provides their specialist knowledge of vector analytics and regulations for ATMPs, Pall bring their overall experience with continuous manufacturing and specifically their upstream vector production, filtration and purification technologies capabilities. And Cobra brings it’s AAV production experience and understanding of the gene therapy market and customer requirements in this market.”

Bottlenecks

The gene therapy space is in its infancy with limited established manufacturing processes. This, according to Coleman, creates the potential for the adoption of the approaches being investigated for vector production and, in the long term, to become standard approaches in this market.

“The current bottlenecks for gene therapy manufacturing are production capacities, low yields and high cost of goods which need to be overcome if the potential of these products is to be realized,” said Coleman.

“Whilst still a new concept in the biopharmaceutical filed, continuous manufacturing platforms have been demonstrated in other product areas such as antibody manufacturing to significantly increase process yields and reduce the production footprint required in manufacturing.

“It is the team’s belief that this concept can be applied to vector production to provide greater operational flexibility, significantly increase vector production capacities of existing production facilities. Also by its nature, it is a scale out, rather than scale up approach which will reduce the risks associated with increasing production capacities.”

Reducing the cost of AAV production

In September, Cobra was part of another three-way collaboration benefitting from a £570,000 Innovate UK grant.

The CDMO is working alongside the UK’s Centre for Process Innovation (CPI) and GE Healthcare to investigate methods to reduce costs for the manufacturing of adeno-associated virus (AAV) vectors.

According to Coleman, the two projects complement each other.

“The collaboration with GE and CPI is focused on a specific chromatographic technology that has applications to AAV purification. This [latest] grant is more holistic, seeking to improve process yields on individual process steps through improved analytical capabilities provided by the CGT Catapult and then adapting these operations to continuous manufacturing platforms with the aim of increasing vector yields by than greater than 25%.”