Moderna And The Building Of Bridge Facilities
By Louis Garguilo, Chief Editor, Outsourced Pharma
In August of 2021, relatively overlooked because of other news swirling around our industry, Moderna became the anchor client in a new cleanroom on demand housed in a bridge facility, in Burlington, Massachusetts.
In retrospect, it may have legitimized a new era in outsourcing.
In fact, this leasing deal for GMP space completed a full circle that started some six years earlier and not too far away in Cambridge, on the 5th floor of the newly constructed facility Moderna was qualifying as cleanroom space for its evolving mRNA research programs.
Ravi Samavedam, who previously worked at Baxter, Amgen and Shire, was a part of the Azzur consulting company whose team had been hired to qualify that part of the Moderna facility.
He recently explained to me what transpired as a result of that interaction. His narrative demonstrates yet again how the emergence of business models drives innovation in our drug development and manufacturing outsourcing industry.
“That's where the idea of ‘cleanrooms on demand’ was born, at Moderna in 2015-16,” says Samavedam.
“We had three months to qualify the facility for internal processing of their first clinical batches.” Until then, he says, Moderna had been an all-outsourced model.
“Well, it actually took us about 18 months and 23 consultants later to get them to cGMP standards,” Samavedam says, now able to laugh at the predicament.
“That's when me and some of my colleagues said, ‘You know what? This is silly. We do this anyways at our client sites as consultants, why can't we just acquire a warehouse space, configure it for cleanrooms ready for a customer like Moderna, and really help these companies accelerate.”
Obviously, there’s a heck lot more involved, but sure enough, the first space Azzur acquired in 2017 wasn’t far from that Moderna facility where the idea was hatched.
And as soon as cleanrooms were GxP qualified in 2018, the first set of customers arrived.
In the meantime, Moderna constructed another “massive facility in Norwood [Mass], hired a lot of people, and obviously became very successful.”
Nonetheless, Moderna contacted Azzur again in 2022 to help them address the demand for Covid variants. Moderna began making a component of their omicron-specific boosters at Azzur’s facility in Burlington.
“So this comes full circle,” says Samavedam, still amazed at what has transpired. “The birth of the idea was working as consultants with Moderna in their facility, and six years later they become one of our first – and today our biggest – clients.”
Moreover, he says, while working with Moderna in Cambridge for those nine months – first hired in as a project manager for the GMP-compliance job, and then transitioned to their head of quality, “I also saw the other side of the story – how tough it could be dealing with the very busy CDMOs, and how supply-chain challenges were a huge issue. That gave me a lot of ideas, particularly that a bridge facility as a hybrid approach was going to work.”
“To be honest, though,” he says, “at first nobody even within Azzur believed in this approach to build and wait for the customer to come – with all their own personnel. It was a struggle for us. And then businesswise, it was a loss leader for a long time.”
Today these bridge facilities are a substantial component of Azzur’s business, and future plans … and maybe the future plans of readers of Outsourced Pharma as others as well start developing these ready-for-your-use facilities.
Broker And Blend
A few things to clarify before moving on.
In part one of my discussion with Samavedam, we learned how Azzur acquires warehouses and converts them into GxP-qualified cleanrooms (of configurable dimensions), and takes care of all related quality and materials maintenance.
However, personnel from the drug or therapy sponsor performs all the work, and the tenant is solely responsible for the output and quality of the product produced there. This differentiates Azzur facilities from CDMOs.
We should also note CDMOs were – as so many of you experienced – heavily taxed by the recent Covid vaccine needs, and other extenuating supply-chain challenges. But capacity availability can change quickly in our industry.
If CDMO capacity opens up and services expand to meet the demands of CGT developers – something we do hear to a degree – again there may be no better option for developers in early stages than to take advantage of what these organizations have to offer.
But our final note before moving on is that CDMOs themselves have shown interest in creating capacity within bridge facilities.
The Azzur white paper (Build Broker Or Blend; published in 2022) says that nearly 90% of CGT developers would prefer to manufacture using CDMOs, “but current lead times are soaring past 18 months with no relief in sight.” (emphasis mine)
According to the white paper, 83% of respondents indicate they have a CDMO product-development strategy in place, and having a clinical-trial-supply manufacturing strategy has become a commonplace in all developers.
Samavedam finds those statistics assuring.
And they’ve provided him with another idea, one that includes a major role for CDMOs.
You May Never Leave
“I’ve thought about this, as a result of having both CDMOs and biopharma clients utilizing our facilities,” he says.
“The ideal vision is we have a CDMO partner, like a Thermo Fisher, that partners with us as our anchor tenant.
“The rest of the facility is run the same as our others, with a variety of mostly early-phase biopharma clients – those who normally are short-term and graduate to a CDMO or back to internal capabilities.”
In this new case, though, they simply move “next door” to their CDMO neighbor.
“We'd provide a recognizable pathway from early phase to potentially commercial,” says Samavedam.
“And while you are utilizing our clean rooms, you can start helping the CDMO next door (who is also leasing space) understand your process. This could minimize tech-transfer time, and build a partnership with that CDMO early on.”
“So it's a paradigm shift. I don't know if we can pull it off, but it could shave years off of current development timelines, and assist both sponsors and CDMOs with capacity flexibility.”