Manufacturing roundup—Moderna taps Baxter for COVID shot production; AGC, WuXi AppTec grow cell and gene therapy ambitions; Prestige Bio plots vaccine plant

A pair of CDMOs are continuing the industry-wide push into cell and gene therapy as Singapore-based Prestige blueprints a vaccine factory for infectious diseases, including COVID-19. (Reptile8488/Getty Images)

Aiming to double monthly COVID-19 vaccine deliveries in the U.S. by April, Moderna has signed on Baxter BioPharma Solutions to tackle fill-finish work at its Bloomington, Indiana, plant.

Meanwhile, Singapore’s Prestige Biopharma, hot off a $539 million IPO on the Korea Exchange, plans to build a vaccine factory for COVID-19 and other infectious diseases, various news outlets reported.

Plus, the industrywide push into cell and gene therapy manufacturing shows no signs of slowing. CDMO AGC Biologics blueprinted a viral vector upgrade at its facility in Italy and WuXi AppTec completed its buyout of British cell and gene therapy specialist OXGENE.

Moderna enlists Baxter for upward of 90M COVID-19 vaccine doses

After teaming up with Novavax earlier this year, Baxter BioPharma Solutions has signed on to fill, finish and package doses of Moderna's mRNA-based COVID-19 vaccine.

Baxter BioPharma, the contract manufacturing arm of Baxter International, is on deck to turn out 60 million to 90 million doses of the vaccine at its Bloomington, Indiana, plant in 2021. The CMO employs more than 700 staffers at its 600,000-square-foot Bloomington campus, where the company makes both clinical and commercial vaccines, including preventive and seasonal shots for the global market. 

Moderna aims to double its monthly vaccine shipments to the U.S. by April, president Stephen Hoge said in testimony prepared ahead of a February hearing with the House Energy and Commerce Committee's oversight arm. Hoge last month said the company was “continually learning and working closely with our partners and the federal government to identify ways to address bottlenecks and accelerate our production,” with fill-finish proving an especially difficult hurdle. 

Baxter's site in Indiana will fill and finish Moderna vaccine doses. (Baxter)

Catalent currently performs fill-finish and packaging work for Moderna's vaccine at its own Bloomington plant. Meanwhile, Hoge last month said Moderna was wrapping up a deal with another filling partner, which has now emerged as Baxter.

This isn't Baxter's first COVID-19 pact, either. The company in January agreed to fill and finish Novavax's late-stage vaccine candidate at its facility in Halle, Germany, to shore up supplies for the European and British markets. Novavax has yet to win a vaccine authorization, but that could change this year. CEO Stanley Erck told CNBC last week that the company anticipates a potential FDA authorization in May. 

Novavax is gunning to hit annual capacity of at least 2 billion doses this year. The company has also pledged an eye-popping 1.1 billion doses of its vaccine to Covax, the equitable vaccine distribution effort co-led by WHO, Gavi and the Coalition for Epidemic Preparedness Innovations. Serum Institute of India will produce the Covax doses, with the facility itself tapped to distribute the shots to low- and middle-income countries outside of India. 

AGC Biologics plots viral vector boost at Milan cell & gene therapy plant

Contract development and manufacturing organization AGC Biologics laid plans for an upgrade to its cell and gene therapy center in Milan, Italy, set to boost overall capacity at the plant and allow AGC to make viral vectors in cell culture suspensions—a process that's easier to scale than the traditional cell culture approach. 

AGC will add two extra floors to the suite and kit out the current floor with additional equipment, with a view to get the new facilities up and running by 2022.

It's the latest move in AGC's cell and gene therapy expansion in Europe, Asia and the U.S., Patricio Massera, CEO at AGC Biologics, said in a release. The company didn't say how much it would invest or whether it plans to sign on new employees. AGC didn't immediately respond to Fierce Pharma's request for comment. 

RELATED: As viral vector demand surges, fledgling CDMO Matica establishes a beachhead in Texas

The Milan expansion comes less than a year after AGC snapped up the facility in its July buyout of cell and gene therapy specialist Molecular Medicine. The takeover set up AGC to offer both plasmid production and end-to-end cell and gene therapy services, the company said at the time. Aside from the Milan plant, AGC also got its hands on a MolMed facility in Bresso, Italy, where the company says it's also plotting a capacity expansion. 

AGC picked up its Milan facility following its buyout of Molecular Medicine in July. (AGC Biologics)

Molecular Medicine's Milan site also boasts the distinction of being the first European facility approved to manufacture ex-vivo gene therapies, AGC said. In October, Molecular Medicine was officially christened AGC Biologics.

WuXi AppTec snaps up OXGENE in cell and gene therapy crusade

WuXi AppTec has taken over British CDMO OXGENE, setting up the gene therapy specialist to become a fully-owned subsidiary of WuXi Advanced Therapies (WuXi ATU)—AppTec's contract testing, development and manufacturing business unit for cell and gene therapies. The move positions WuXi AppTec to provide end-to-end cell and gene therapy services, the company said. 

OXGENE, based out of Oxford, England, will hold onto its name as it's folded into WuXi ATU. The OXGENE site also marks WuXi ATU's first foray into Europe. 

With OXGENE on deck, WuXi AppTec will provide CDMO services for cell and gene therapies "from early genetic molecular research and discovery" through manufacturing "at scale for global commercialization," a WuXi AppTec spokesperson said via email. 

RELATED: Biogen cements gene therapy ambitions with $200M factory in Research Triangle

WuXi AppTec set its sights on OXGENE for its adeno-associated viral (AAV) and lentiviral manufacturing prowess, the spokesperson added. OXGENE's TESSA technology, used for AAV production, provides a plasmid-free alternative for large-scale clinical manufacturing, while its lentiviral-focused XLenti system, based on the company's SnapFast plasmid technology, is designed to offer better yield, quality and safety, according to OXGENE's website.

Those processes should simplify cell and gene therapy manufacturing and save on costs, WuXi AppTec said. 

With the addition of OXGENE's U.K. operations, WuXi Advanced Therapies now boasts a footprint in Philadelphia, Wuxi, China and Europe, the spokesperson said. 

Prestige Bio blueprints vaccine plant weeks after $539M Korean IPO

Antibody drug developer Prestige Biopharma plans to build a vaccine factory for COVID-19 and other infectious diseases, Korea Biomedical Review reports. The 8,500-square-meter (91,493-square-foot) facility will be on deck to serve manufacturing needs for various infectious diseases, including the novel coronavirus.

The plant is expected to have 100,000 liters of production capacity upon completion. Construction will start this month and wrap up by year-end, Korea Biomedical Review said. 

The Singapore-based drugmaker in February ginned up 453 billion Korean won ($539 million) from an initial public offering on the Korea Exchange, The Business Times reports. Prestige says it will use those funds to break into the global pharmaceutical market by investing in R&D and facilities. The company has marketing authorizations in the works for a trastuzumab biosimilar to Herceptin and a Bevacizumab biosimilar to Avastin. 

Meanwhile, Prestige also has an anti-PAUF monoclonal antibody and an Adalimumab biosimilar in clinical development.