Facilities & Capacity Archives - Page 35 of 73 - BioProcess InternationalBioProcess International

Pfizer/BioNTech recruits Rentschler to support COVID-19 vaccine

CDMO Rentschler will be responsible for downstream processing of batches of Pfizer/BioNTech’s COVID-19 vaccine candidate BNT162b2 from its site in Laupheim, Germany. BNT162b2 is one of the frontrunners in the race to develop a vaccine against COVID-19. The Phase III candidate is based on messenger RNA (mRNA) and being produced at several facilities in Germany run by developer BioNTech. But now BioNTech and its partner Pfizer have selected contract development and manufacturing organization (CDMO) Rentschler to support production as it…

Competition for CMOs drove inhouse investment, says Regenxbio

by Gareth Macdonald

Regenxbio says increasing competition for capacity in the CMO space prompted the adoption of a hybrid gene therapy manufacturing strategy. Industry demand for contract manufacturing organizations (CMOs) with the technical skills required to manufacture gene therapies has increased in recent years. According to the Alliance for Regenerative Medicine, as of Q3 last year, 370 trials involving gene therapies were ongoing, which is an increase on the 351 underway in the equivalent period in 2018. Katie Masterson, director of manufacturing operations…

Arranta says GMP plant on track despite pandemic

by Gareth Macdonald

Microbiome contractor Arranta Bio says construction of its commercial scale manufacturing plant is on schedule despite the coronavirus pandemic. The contract development and manufacturing organization (CDMO) announced the mechanical completion of GMP suites at the facility in Watertown, Massachusetts this week. CEO Mark Bamforth thanked, “Our construction management partner, DC Beane and Associates Construction Company…and the numerous sub-contractors who have supported Arranta and worked through the pandemic in a safe and efficient manner to keep our commercial-ready manufacturing facility build-out…

Novavax and J&J ink COVID-19 vaccine fill/finish deals

by Dan Stanton

To support their COVID-19 vaccine candidates, Novavax has secured space at Endo’s facility and Johnson & Johnson has struck a deal with Grand River Aseptic Manufacturing (GRAM). As Novavax progresses its COVID-19 vaccine candidate through the clinic, the firm has inked numerous deals with contract development and manufacturing organizations (CDMOs) to ensure it will be ready for large-scale production. The latest focuses on the fill and finish of the Phase II candidate, NVX-CoV2373, with a deal in place with Par…

Catalent adds early-stage plant to its blooming(ton) fill/finish business

by Dan Stanton

CDMO Catalent says it is looking to serve fill and finish demand for early-phase customers in its $14 million acquisition of a second facility in Bloomington, Indiana. Three years after AB BioTechnologies broke ground on a 23,000 square-foot facility, fellow contract development and manufacturing organization (CDMO) Catalent has acquired it for $14 million – $3.5 million more than the 2017 investment. The facility adds clinical and small-scale commercial manufacturing for injectable drugs to Catalent’s growing fill and finish network and…

From flu jabs, to mAbs, to COVID collabs: BioNTech nabs Novartis plant and labs

by Dan Stanton

BioNTech is buying Novartis’ facility in Marburg, Germany to support the manufacture of its mRNA vaccine candidate against COVID-19. Financial details of the acquisition have not been divulged, but the GMP facility in Marburg (about 50 miles north of Frankfurt) will be used to increase manufacturing capacity for BNT162b2, a Phase III messenger RNA (mRNA) vaccine in development with Pfizer against COVID-19. The Novartis facility houses equipment to produce recombinant proteins, and cell and gene therapies – as well as…

Moderna says ‘simple’ mRNA process allowed speedy COVID vaccine scale-up

by Dan Stanton

The cell-free and enzymatic nature of its mRNA technology has allowed Moderna to quickly build a relatively small network capable of supporting commercial manufacture of its COVID-19 vaccine. On Monday, President Trump named Pfizer and J&J as leading the way in bringing a coronavirus vaccine to market. But also speaking Monday, Tal Zaks, chief medical officer at Moderna Therapeutics, believes it will be his firm that will be the first to bring both a vaccine to market and “to deliver…

Samsung Bio adds another Big Pharma customer with $331m AstraZeneca deal

by Dan Stanton

AstraZeneca will grow its production network into Asia-Pacific through a contract with Korean CDMO Samsung Biologics for large-scale drug substance manufacturing. Anglo-Swedish pharma firm AstraZeneca is teaming with contract development and manufacturing organization (CDMO) Samsung Biologics in a long-term deal worth an initial $330.8 million, though this could rise to $545.6 million. The specific products to be made at Samsung Biologics’ site in Incheon, South Korea have not been disclosed but AstraZeneca has numerous biologics commercially available and a number…

Takeda opens MA manufacturing unit to support cell therapy R&D

by Dan Stanton

The 24,000 square-foot cell therapy manufacturing facility will produce material through to Phase IIb trials, supporting Takeda’s cell therapy ambitions. In 2019, Takeda expanded its presence in the oncology cell therapy space inking a series of deals and establishing an internal translational cell therapy engine. To support this, the firm invested in a cell therapy manufacturing center at its R&D headquarters in Boston, Massachusetts which opened this week. “The R&D cell therapy manufacturing facility will produce cell therapies for clinical…

Novavax teams with Serum for mass vaccine supply: ‘We can’t do that, they can’

by Dan Stanton

Novavax has contracted India’s Serum Institute to make more than a billion doses of its protein-based COVID-19 vaccine candidate, pushing total capacity to 2 billion doses across its network. NVX-CoV2373 is a potential vaccine against the COVID-19 consisting of a prefusion protein made using Novavax’ nanoparticle technology based on infecting Sf9 insect cells with baculovirus viral vectors that express the SARS-CoV-2 spike protein. The vaccine is also being tested with Novavax’ Matrix M adjuvant, a saponin-based adjuvant that acts in…