Baxter announces agreement with Novavax; BARDA adds AMRI facility; Lonza collaborates with Capricor to develop candidate; Fujifilm will help to manufacture Novavax’s COVID-19 candidate. Great to have you here for Bioprocess Insider’s CDMO round-up.
First up in our contract development manufacturing organization (CDMO) round-up is Baxter BioPharma Solutions, which recently confirmed a sterile manufacturing agreement for Novavax COVID-19 vaccine, NVX-CoV2373.
“Baxter’s sterile manufacturing services will take place at our facility located in Halle/Westfalen, Germany using existing manufacturing capacity. The facility has onboarded limited additional personnel to manage peak demands facility-wide,” a spokesperson for Baxter told us.
Image: iStock/GreenApple78
Currently, the vaccine candidate is in Phase III trials and is awaiting authorization and approval for use. The partnership aims to advance large-scale manufacturing for the vaccine’s production and commercial distribution in the UK and European markets.
Fujifilm
Secondly, we have Fujifilm Diosynth Biotechnologies who have confirmed that they will manufacture Novavax COVID-19 vaccine continuously throughout 2021.
Operation Warp Speed has helped speed up the expansion of Fujifilm’s biomanufacturing facility which will accommodate large-scale production of the COVID-19 vaccine candidates.
The production has already begun at Fujifilm’s Texas facility in College Station.
Fujifilm’s chief operating officer Gerry Farrell said, “we have the largest single-use facility in the US and that’s a scale-out facility where we can scale up various vaccine manufacturing products.”
Farrell continued, “Today we are manufacturing material, stockpile material, so when Novavax gets approval the material here, the material we have produced can be used to vaccinate the population,” adding “we’re manufacturing that two by two-thousand-meter scale, we will turn those bioreactors every four days and produce up to seven batches per month.”
AMRI
Up next is Albany Molecular Research (AMRI). AMRI has announced its facility in Albuquerque, New Mexico has been included in the Biomedical Advanced Research and Development Authority (BARDA) CDMO network.
The collaboration is part of the US government’s initiative to improve preparedness capabilities. The chosen site is currently supporting COVID-19 vaccine production and boasts a large-scale fill and finish facility.
CEO John Ratliff said the partnership reflected “our commitment to play a vital role in the COVID-19 pandemic response” adding it “enables us to contribute to this critical moment in improving help.”
AMRI joins BARDA’s rapidly expanding partnership programme which has around other partnerships in response to fighting COVID-19.
Lonza
Fourth in line is Lonza. Lonza has revealed their collaboration with Capricor to develop cell therapy candidate, CAP-1002. If approved, CAP-1002 aims to treat patients with Duchenne Muscular Dystrophy (DMD) and difficulties arising from COVID-19.
The partnership hopes to increase Capricor’s current manufacturing capacity and the development process will take place at Lonza’s 300,000-square-foot facility in Houston, Texas.
Lonza’s senior vice president, Albert Santagostino said “We will leverage our process development expertise and industrial manufacturing capabilities to enable Capricor to scale this therapy.”
In other news, Cytiva announced last week that it has successfully completed another KUBio installation at Lonza’s Chinese plant in Guangzhou Biopark. Construction of the facility, which will house 1,000 and 2,000 L bioreactors for cGMP manufacturing plus pilot-scale in the development labs began in 2018