CEO of Michigan CDMO explains how he nabbed monkeypox vaccine contract
As US cases of the monkeypox outbreak have now risen above 14,000, the government is moving quickly to make more doses available, with the Jynneos vaccine looking to be deployed wider as Bavarian Nordic’s sites in Europe get the all-clear from the FDA.
Meanwhile, a Grand Rapids, Michigan-based CDMO landed a deal with Bavarian Nordic, to fill and finish the vaccine. Grand River Aseptic Manufacturing, a relatively new player in the CDMO world, only being around since 2010, announced it received the deal from Bavarian Nordic as well as approval from HHS and BARDA to increase the domestic supply of Jynneos.
Tom Ross, CEO of Grand River, said in an interview with Endpoints News, that a major reason why the company managed to net such a high-profile contract was due to the company’s previous work with BARDA in Operation Warp Speed, producing the J&J vaccine during the height of the Covid-19 pandemic.
“When Bavarian Nordic was looking for a US-based CDMO I think we were one of the few companies that BARDA had recommended and that led to some discussions and we were very impressed by Bavarian Nordic I think they liked what we had to offer here and they came out and saw our facilities,” Ross said to Endpoints.
Ross also added that another piece that attracted Bavarian Nordic was that Grand River has invested a large amount of capital to improve its facilities recently. The company netted a $120 million grant from the US government to expand its fill-finish sites, with the company investing $40 million of its own money to expand its 80,000-square-foot, large-scale filling facility and 200,000-square-foot finishing center in Grand Rapids. The company has also recently finished two new manufacturing lines in a $50 million investment as well.
For the deal with Bavarian Nordic, Grand River will receive the bulk drug substance and Grand River doing the formulation and filling vials and eventually distribute through Bavarian’s distribution channel. Ross said that Grand River will be producing millions of vials, but the exact number is yet to be determined as it is uncertain how many doses will be needed.
While the financial terms of the deal were not disclosed to Endpoints, the company is planning to make more hires over the next two to three months and has already ramped up the hiring process, Ross said.
And while the overall deal came together in a very short period, according to Ross, the tech transfer is now kicking into gear in an accelerated fashion, but it will take a few months to get fully up and running as it conducts engineering runs and other processes. Ross told Endpoints that full-scale commercial production is expected to start in 2023 Ross said.
While Ross did not comment on the record if Grand River will net another BARDA contract for monkeypox vaccine manufacturing, he did note that the situation is a bit different from the Covid-19 situation that it has faced but that some of the elements remain.
“It’s not as big as a COVID response, of course, but in terms of the intensity the timing, and the urgency it’s all the same,” he said. “It’s important to respond and try to do what we can collectively to respond, and the vaccine is one of the tools.”