Gene therapy firms want vector contractors with experience and capacity according to Cobra Biologics CEO, Peter Coleman, who says characterization know-how is in demand. When Memphis, TN-based CDMO Cognate BioServices said it would buy Cobra (a UK firm) this month it cited demand for plasmid DNA and viral vectors as the driver for the deal.

Cognate is not the only firm to have noticed the trend.  In October, Cytovance said demand from gene therapy firms had prompted it to up plasmid DNA capacity at its Oklahoma City plant.  And when GE Healthcare launched its KUBio Box platform a few weeks later, it highlighted the shortage of viral vectors as part of its marketing campaign.

But gene therapy developers are looking for more than just plasmid and vector capacity, notes Coleman.

“There is clearly a strong demand out there for viral vector capacity but, importantly, [this comes] along with a track record and expertise. Investment in capacity is being made, but one of the key drivers for Cognate to acquire Cobra was the inability of their cell therapy customers to source available and timely viral vector capacity.”

Move in the right direction

Viral vector sourcing has been a challenge for gene therapy developers for the past few years. In 2018 the Alliance of Advanced Biomedical Engineering warned about the lack of vector capacity. Even mainstream publications like the New York Times have raised concerns about biopharma’s lack of viral vectors.

As an article (“Transferring Viral Vector Production from Plasticware to a Fixed-Bed Bioreactor”) in the February 2019 issue of GEN noted, scaling up the adherent cell cultures used to produce viral vectors is one of the major challenges. Such cultures are hard to scale up because of “the large number of flasks, roller bottles or cell factories that need to be manipulated during a clinical production run.”

Coleman has a similar take: “Viral vector production at scale is challenging, hence the limited number of competitors out there.”

Plasmid DNA

DNA plasmids are vital for cell line development. They are also used in the production of gene therapies. And demand for plasmid DNA is increasing, emphasizes Coleman.

“There continues to be a strong demand from both new and existing customers, from small scale ‘GMP like’ High Quality DNA through to large scale commercial supply. We have also additional demand move from the traditional DNA vaccine or gene therapy indications to now gene editing and personalised medicines.”

At present Cobra is installing two extra GMP grade plasmid DNA production suites at its facility in Matfors, Sweden to cater for growing customer needs.

“Customers always have an optimistic view on timelines and the generally held view is that DNA production is straight forward and all plasmids behave the same way,” points out Coleman. “Cobra is expanding capacity at all levels of scale to meet timeline expectations and we have a tried and trusted platform which provides consistent performance, not just in productivity but also DNA quality and timelines.”

Future challenges

At present, industry has yet to settle on preferred plasmid DNA and viral vector production methods. But in time, the focus is likely to shift towards ways of improving productivity. New analytical technology will be key, according to Coleman, who says current systems are more suited to the lab than the factory floor.

“A major challenge still exists around the industry’s ability to perform rapid process development and scaleup due to the lack of ‘fit for purpose’ characterisation methods and tools,” he explains. The development of process analytics for viral vectors has fallen behind our understanding of the various production systems and technologies that are being used. As such it is extremely difficult to correctly and accurately characterise in-process material and help inform rapid process development decisions, relating to vector production.”

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