Moderna and Azzur Group have worked together for more than six years in the Boston area, and the mRNA COVID-19 vaccine producer will now become the anchor client in Azzur’s newest COD facility in Burlington, Massachusetts. That site will open in October and is already 100% booked.
As well as Burlington, Azzur has another COD location in Massachusetts, in Waltham. It also has COD facilities in Vista in California, with further expansion into the Raleigh, North Carolina, San Francisco, California and Philadelphia, Pennsylvania’s markets planned over the next 18 months.
Commenting on the use of Azzur’s COD space, Jason Ellow, Moderna’s senior director of clinical manufacturing, noted. “As Moderna grows at an accelerated pace, there is a clear need to expand our clinical manufacturing capacity. Azzur’s Cleanrooms on demand allows us to swiftly grow our footprint, alongside a partner that fully understands challenging timelines and the complexities of pharmaceutical manufacturing. COD will allow us to bring online new space, and let us focus on building our team, developing and improving our processes, and delivering product to the clinic.”
Build or broker
Cleanrooms on demand is a practical answer to the classic dilemma for fast-moving pharma companies – whether to build or broker, said David Frank, senior director of sales and marketing, Azzur Group, on a call with BioPharma-Reporter yesterday. "Do they build their own cleanroom facilities – a process of two to three years and millions of dollars - or outsource development to CMOs – a segment of the industry glutted with a backlog waitlist of work estimated at 18 months or more," he queried.
The trip from discovery to delivery of pharmaceutical products means companies of all sizes are routinely stuck on the horns of this manufacturers’ dilemma, said Frank.
There have been very few effective ways to avoid this impasse, to speed up the timetable of pharma manufacture, but Cleanrooms on Demand (COD) offers a logical alternative that can reduce or eliminate the risks of those other costly and time-consuming options, he argues.
“Clients had asked us, over and over again, starting in and around 2015, for a space they could use, on a short-term basis, whereby they could do development and small batch manufacturing for phase 1 and phase 2 clinical trials, a space that was readily available for GMP production that they didn’t have to go build, a facility that would mean they didn’t have to wait in line at a CMO.
“In essence, they wanted somewhere that they could control their process and production, and not hand that over to a third party, to get their drugs made in an expedited fashion. In 2017, we decided to give them what they were asking for, and that was when COD in Waltham, MA was born,” said Frank.
Azzur is first to market in terms of doing this from a cleanroom perspective, he said.
There are many advantages to this approach. Azzur manages the space and the services associated with the COD. “We build it, the company brings the science and we bring the GMP compliance expertise; the biotech maintains full production control,” continued Frank.
Its cleanrooms are modular in terms of construction rather than being stick-built. “Modular panels give clients lots of flexibility, the space can be modified according to customer needs. In addition to the actual real estate itself, we provide on-site materials management services, as well as a lot of the consumables like the gases that the companies would use. The biotech provides its own process equipment and its own manufacturing staff, as it is doing the process development along with all the oversight.”
The model moving forward is that each Azzur COD facility would have around 20 to 25 cleanrooms.
“What we often see is that many companies take multiple cleanrooms based on what their business need is. So, on average, that translates to about two cleanrooms per customer, with our most recent client being the exception to that. Typically, though, we would be catering for about 10-12 companies per facility.”
Biotechnology companies, primarily cell and gene therapy (CGT) players are the target clients for cleanrooms on demand, he said. “They are the ones that use such spaces most effectively, everything in these facilities is single-use,” said Frank.
“As we envisaged these, the ideal client is a company that it is starting up production for phase 1 or phase 2 clinical trials, that wants to hold onto its own process and make small batches, not yet commercial stage product. But what we have also seen is that very large companies – Moderna, for instance, and others as well - are finding value in using our facilities to expand their R&D. They realize there is an advantage to having somebody else manage the facility and the GMP compliance side, and they can just focus on the science.”
Using such facilities, he said, companies of all sizes eliminate the risk, time, and expense of a capital expansion or the need to share IP and technology know-how with a third-party that is carrying out the process on their behalf.
Upfront capital costs
There are other advantages to working with an organization like Azzur COD: “There is a 90-cancellation window. If something does not work, you can get out of the contract within a three month period. In general, when a company wants to secure space in one of our cleanrooms, we ask for a deposit of roughly three-months’ worth of facility rent and services, which comes to about US$300-500K depending on what they are running and how they are running it in the facility. But that would typically be the upfront capital cost.”
Azzur has funded the first three COD builds through the profits of the business. In addition to the cleanrooms on demand division, the Azzur group umbrella comprises advisory, consulting, laboratory, and training services. In April this year, it announced a minority partnership with Baird Capital. That investment will accelerate the growth of its COD offering while augmenting Azzur’s other divisions.