Of all the contract manufacturers to enter the spotlight during the COVID-19 pandemic, Novartis remains one of the most surprising.
The formal unveiling of the Swiss pharma’s CMO arm may be relatively fresh, but the company’s production focus stretches back decades, Anton Gerdenitsch, Novartis’ global head of contract manufacturing, said in a recent interview.
Before the company's high-profile COVID production pacts with Roche, CureVac and BioNTech, Novartis had been carving out a spot in the contract manufacturing scene for more than 20 years, the executive explained. Over that stretch, the drugmaker has honed its production expertise in areas such as enzymes, proteins and antibiotics and garnered a “very solid customer base,” Gerdenitsch said.
More recently, Novartis has witnessed a deluge of production requests for newer technologies.
“We’re living in extremely exciting times,” Gerdenitsch said of the current contract manufacturing zeitgeist. “Especially the biotech and cell and gene space has seen an explosion of rapid development over the last years.
“We have now countless very specific medications requiring very specific technologies: monoclonal antibodies, fragmented antibodies, nanobodies, [antibody-drug conjugates], viral vectors, DNA, RNA—and the list goes on and on,” he added.
“I clearly see that CMO services will increase significantly in the coming years as no company can really master all those specific technologies by themselves.”
Enter Novartis’ Global Biotech Cooperations, which boasts a wide arsenal of technologies available around the world.
"We're not focusing on one or two different technologies, so in this biotech and cell and gene space, I don’t see any missing technology in our network,” Gerdenitsch said.
Meanwhile, given Novartis’ scale, the company is equipped to support not just manufacturing but “all steps of the life cycle of a medicine,” the executive pointed out.
The company can support customers in development, registration, marketing, market access, logistics and distribution, Gerdenitsch said.
Another perk is the company’s size and “financial stability,” which means Novartis has the capacity to stick around as a partner long-term. Finally, as one of the world’s top biopharma companies, Novartis’ CMO grants other companies access to its “stable and sustainable global supply chain,” with a vast network of long-standing suppliers, Gerdenitsch noted.
The stability of those supply chains is more important than ever against the backdrop of the COVID-19 pandemic, the executive added.
Bringing CAR-T lessons to the masses
There’s no doubt the pandemic “triggered” many of Novartis’ most recent and best-known production alliances, Gerdenitsch said, but prior to COVID-19, the company was already privy to “strong and sustainable growth in contract manufacturing, especially in the biotech and cell and gene space.”
Novartis’ contract manufacturer put another foot in the cell and gene arena in March when it agreed to manufacture Carisma Therapeutics’ HER2-targeted CAR-M cell therapy, currently in initial studies to treat solid tumors.
Under that deal, Novartis aims to kick off clinical manufacturing of the cell therapy candidate from its site in Morris Plains, New Jersey, starting next year.
Meanwhile, demand alone isn’t fueling the current CMO boom; many newer modalities like cell and gene therapies are also exceedingly difficult to make.
“We are seeing also that more and more companies are really struggling with these new emerging technologies—to get the required capacity, the right quality and to bring the modern medicines to market,” Gerdenitsch said.
Hundreds of cell and gene players are propelling candidates through the clinic, but many of those companies are “often lacking” when it comes to large-scale, high-quality production capacity for late-stage clinical trials and commercial manufacturing, Gerdenitsch said.
Novartis, on the other hand, is “one of the front runners” in the field, boasting commercial assets such as CAR-T Kymriah in acute lymphoblastic leukemia and large B-cell lymphoma.
Production of the complex personalized medicine hasn’t been without its hitches, but over the years, Novartis has built out “extensive internal manufacturing capabilities for cell therapies” that form one of its CMO’s key strengths, Gerdenitsch said.
Aside from the actual production of cell therapies, Novartis also makes vital components for the personalized medicines such as viral vectors, which have been in shortage for some time, many in the industry have warned.
The final piece
The scope of Novartis’ manufacturing offerings is apparent when you look at the company’s trio of 2021 COVID-19 pacts. Last March, the Swiss drugmaker agreed to chip in on production of mRNA and bulk drug product for CureVac’s COVID-19 vaccine prospect CVnCoV. Then, in April, Novartis said it would reserve active pharmaceutical ingredient capacity for Roche’s rheumatoid arthritis med Actemra, which has run the gamut of COVID-19 trials, some successful and others not.
Elsewhere, Novartis agreed to assist with production of Pfizer and BioNTech’s mRNA vaccine Comirnaty, helping fill shots at sites in Switzerland and Slovenia.
Demand for fill-finish services has skyrocketed during the pandemic, Gerdenitsch said.
Now, as the pandemic ebbs, demand for that crucial manufacturing step is leveling off as well, he said. Still, there remains “a lot of demand, especially in small- to medium-scale filling capabilities for all these very complex biotech clinical studies,” Gerdenitsch said.
Looking ahead, Novartis’ Global Biotech Cooperations unit aims to strike more partnerships, especially in the biotech and cell and gene therapy market, the executive said. Meanwhile, the company will weigh further investments in production where demand dictates. It’s currently focusing on “hot topic” areas like viral vectors, DNA, RNA and antibody-drug conjugates.
“The strategy of this organization is to deliver high quality medicines on time, every time, safely and efficiently,” Gerdenitsch said. “We really strive to become one of the top manufacturers of innovative and generic medicines in the industry.”