The initiative is building on the success of Novartis' collaborative partnerships in the last two years, such as the tie-up with BioNTech for the filling of its COVID-19 vaccine, and the deal it secured in March with Carisma Therapeutics to produce the Philadelphia-based company’s HER 2 targeted CAR-Macrophage (CAR-M) cell therapy.
Anton Gerdenitsch is heading up the CDMO operations at Novartis, which includes 15 biotech and cell and gene sites in Europe, the US and Asia. He joined the company in 2017 as manager of one of its biotech sites and the external supply of biologics.
GBTC is part of Novartis’ Technical Operations, a division that has not been affected by the recently announced restructuring process within the wider group, he told BioPharma-Reporter on a call last week.
Indeed, the unit is set to expand its footprint, it is actively seeking new clients, and will continue to meet the growing demand for high-quality CDMO services, said Gerdenitsch.
Novartis has been undertaking contract manufacturing for many years for specific technologies, mainly enzymes, proteins and antibiotics, and, in those areas, it has established many successful partnerships, he said, but it is looking to work more strategically now as a CDMO.
“In the past two to three years, we have received an increasing number of requests for support in developing a variety of newer therapeutics, such as for mRNA and DNA based products, for viral vectors, and for cell and gene therapies, and we have also seen companies struggling with these emerging technologies in terms of ensuring the right capacities and the right quality to bring products to market.
“We believe this is where Novartis can really help as we have built up a global development and manufacturing network with end to end capabilities for these technologies, and we can give companies broad access to those,” continued Gerdenitsch.
GBTC is engaging with US, European and Asian customers. “We work with biotech companies, but also with startups on clinical trial development, and with large pharma companies that are looking for a second source, for example, for already established compounds.”
The division provides a wide range of CDMO services, he continued, including mammalian microbial fermentation, filling of multiple container types, global packaging logistics, viral vector production, and very specific RNA expertise that covers the full value chain from plasmid DNA manufacturing through to formulation to fill finish.
Cell and gene therapies
When it comes to cell and gene therapy (CGT) developer support, the Novartis unit can leverage three manufacturing and development sites for cell therapies and two for gene therapies within its network, he said.
In terms of the recently announced tie-up with Carisma, Gerdenitsch noted the US company has a broad pipeline with promising cell therapy products. “We are cooperating with Carisma out of our US site, at Morris Plains, US, and we are planning to manufacture clinical trial material for that company in the second half of the year.”
And he firmly believes the CGT arena will have replicated the mAb success story within five years’ time. “The CGT field is only developing, but over the years, we have seen more products coming to the market.”
Supplier network
Novartis’ rivals in the CDMO area are pure-play organizations and Gerdenitsch acknowledges that the space is highly competitive, but he stressed that GBTC, being part of a larger organization, means it operates to very high standards in terms of quality, and it can also offer its customer financial stability, and a network of global suppliers.
“There has been huge demand over the past two years for resins, for filter materials, and for disposables, etc., and it was challenging to be able to secure the right quantities of those components, with the right quality, at the right time, so it helped us to have this vast supply network.”
The division is also able to provide marketing activities to customers and leverage the group's regulatory expertise, gained over many years, he added.
