Can A Biotech Create A CDMO Market?
By Louis Garguilo, Chief Editor, Outsourced Pharma
For all the yin and yang circling vaccines and the consumer/patient landscape, this segment of our industry had an estimated market value to producers of over $47 billion in 2025.
As today’s headlines suggest, vaccine development is simultaneously global, and domestically targeted and regarded.
It’s altruistic and big business. There’s worldwide opportunity, but elusive sustained profitabily.
But not all production designs fit the outsourcing model. CDMOs must see a growing market they can be profitable within.
Therefore, Dodd knows we must concentrate even more on how drugs and therapies are manufactured — and whether outsourcing models align with technology platforms arising from biopharma organizations.
There are additional concerns heightened by COVID and other disease outbreaks, including national biosecurity.
Dodd has experience in all aspects of this discussion, most specifically related to GeoVax’s Modified Vaccinia Ankara (MVA) vaccine we learned about in part one.
I offer readers this part two of my discussion with Dodd because the challenges and lessons learned here travel beyond vaccines to cut across all your outsourcing sectors.
Model Meets Platform
GeoVax’s infectious disease portfolio is now entirely built on MVA.
Dodd calls the technology “exquisitely safe,” uniquely capable of expressing multiple antigens, and valuable for immunocompromised populations as well as for more traditional vaccine needs.
He’s also candid about why most large vaccine players (and CDMOs) abandoned this technology.
“MVA manufacturing is slow and cumbersome,” he explains. “Every production run is essentially primary. You go back to scratch each time.”
Nonetheless, says Dodd, consider what has been the traditional vaccine-making method of utilizing chicken embryonic fibroblasts (CEF). This entails sourcing specific-pathogen-free eggs, growing primary cells, infecting, harvesting, crushing, purifying — a multi-month process with, in fact, limited scalability.
Of course some dramatic changes have filtered through. Famously, we now have mRNA vaccines, as well as other methodologies either commercialized or in the clinic.
Dodd is sticking with MVA. Unfortunately, very few CDMOs have. Actually, none in the U.S.
There are valid reasons for the CDMOs’ timidity. Their business model is financially rewarded by repeatability, platform efficiency, and high-throughput bioreactor utilization.
Adenovirus, mRNA, monoclonal antibodies — these can be standardized, scaled, and slotted into existing infrastructure. They fit the productive and profitable outsourcing template.
Moreover, as mentioned above, CDMOs have not been asked to work on MVA. Without bigger pharma as “anchor customers,” says Dodd, U.S. CDMOs have seen no justification for building expertise around an admittedly idiosyncratic, labor-intensive platform.
CDMOs are not just "a pair of hands,” as we all know today. But neither are they technology speculators.
Their capital expenditures are driven by customer-demand curves, not (theoretical) dreams of biotechs – even as is the case with vaccines, if they come with major national biosecurity implications.
MVA has been a vaccine platform dependent on major stockpiling. In other words, one-time demand surges that then fall off a cliff for years. Certainly not a priority for CDMOs, or justification for infrastructure and development investment.
Meanwhile, platforms like mRNA have demonstrated explosive commercial demand. Adenovirus vectors are backed by large pharmaceutical partnerships. Antibody production has filled stainless steel facilities worldwide.
So when Dodd says, “We talked to every CDMO with requisite MVA experience – none here in the United States” – that’s not an indictment of our outsourcing market or CDMOs.
It's an understandable reality, and thus GeoVax decided to change things up.
Internal Innovation Is Leverage
Rather than abandon the MVA-platform promise, GeoVax licensed ProBioGen’s continuous avian AGE1 cell line — replacing the company's approach with a suspension-based system.
Instead of starting from scratch for every batch, a continuous cell line allows scalable upstream processing in bioreactors. Yields improve. Production runs multiply. Manufacturing begins to look like modern biologics production rather than agricultural processing.
CDMOs in the U.S., hopes Dodd, will take notice.
He reports roughly a tenfold yield improvement versus traditional methods, plus increased batch frequency. If validated at commercial scale, this “shifts MVA from legacy burden to a bioreactor-compatible platform.”
Once manufacturing moves into a suspension cell-line format, the platform becomes more attractive to CDMOs already configured for large-scale biologics. It fits existing stainless steel or single-use infrastructure. It reduces specialized egg-sourcing requirements. It improves capital efficiency.
In short, it starts to look like something CDMOs know how to monetize. Is the overall suggestion here that biotechs today may have to change programs to meet the needs of external partners?
It very well might be
Innovation, Not Bricks and Mortar
GeoVax has never intended to build its own manufacturing plant. “Our model has always been to use a CDMO,” Dodd says. As we learned earlier, that model has been realized outside the U.S. Today GeoVax manufactures its MVA products through Oxford BioMedica’s European facilities.
The better news, says Dodd, is Oxford BioMedica has begun to operate in Boston and North Carolina, “and with continuous-cell MVA validation progressing, the contours of a U.S.-based strategic partnership is emerging.”
The greater learning here?
Programs unattractive to CDMOs under one manufacturing paradigm may become viable under another. But Dodd knows that requires internal fortitude at the biotech, and at least a flexible outlook and relationship between sponsor and provider.
And even if the strong desire is to be partnered in a certain part of the world, you have to go where the CDMOs can and are willing to bring on your programs.
It appears for GeoVax, its perseverance is paying off. The European Medicines Agency (EMA) recently granted GeoVax an expedited path for its poxvirus (e.g., mpox and smallpox) vaccine (GEO-MVA), requiring a single Phase 3 immuno-bridging study.
And now, with its European CDMO setting up relevant facility-operations in the U.S., GeoVax is coming home.
Regarding the strategic biosecurity need for onshore development and manufacturing, Dodd looks for “procurement signals rather than patriotic rhetoric” from members of the U.S. government.
“CDMOs respond to demand visibility,” he says.
“If the U.S. government wants domestic MVA capability, it can create anchor demand with advanced purchase agreements, platform-development funding, and co-investment in validation.”
That plea aside, important to understand is that while biotechs of all kinds are by nature risk takers (and often trailblazers), CDMOs are somewhat less so (and read markets).
Those cultures must find a platform to work together. If continuous-cell MVA succeeds, GeoVax may again fit into an outsourcing model, one it helped create.