Author Archives: Millie Nelson

Going Dutch: Intravacc paves way for in-country vaccine production

CDMO Intravacc has started a concept design for a so-called ‘Multi-Purpose Vaccine Production Plant’ in response to COVID-19. Dutch contract development manufacturing organization (CDMO) Intravacc has signed a letter of intent alongside Bilthoven Biologicals, Poonawalla Science Park and Alt Foundation to begin developing a Multi-Purpose Vaccine Production Plant (MPVPP) at Utrecht Science Park, Bilthoven. According to Intravacc, the coronavirus pandemic has exposed the vulnerability of the Netherlands regarding the development and manufacturing of vaccines for its own population.  The firm…

Fujifilm says Denmark expansion meets continued CDMO demand

Fujifilm Diosynth Biotechnologies says the continual growth of the biopharma CDMO market means its Danish site will help meet industry demands as it begins its $928 million cell culture expansion project. In June 2020, the firm announced plans to invest $928 million to double capacity at the Danish site it acquired from Biogen in 2019. The capacity was 90,000 L and the expansion (which started last week) will boast another six large-scale stainless-steel tanks, giving a total capacity of 240,000…

Novartis inks COVID-19 vaccine deal with CureVac

Novartis is the latest firm to partner with CureVac and plans to help make up to 250 million doses of its COVID-19 vaccine candidate, CVnCoV by 2022.  The Swiss firm is set to support manufacturing of CVnCoV, an mRNA-based COVID-19 vaccine candidate, which is currently in Phase II studies and expected to merge into a Phase III efficacy trial. The manufacturing is anticipated to start in Q2, 2021 at Novartis’ site in Kundl, Austria. The firm is aiming to produce…

Cell & gene CDMOs: Expansions by AGC, Celonic, Resilience

AGC Biologics plans to expand its cell and gene therapy center; Celonic has a new production site and Resilience acquires a manufacturing facility in Canada. Great to have you here for BioProcess Insider’s CDMO round-up. First up in our cell and gene contract development manufacturing organization (CDMO) round-up is AGC biologics which recently announced plans to expand its cell and gene therapy center located in Milan, Italy. The expansion will up its capacity and install viral vector suspension capabilities. The firm acquired Molecular…

Rivals unite: J&J inks vaccine deal with Merck

Merck & Co. has partnered with J&J to help manufacture its single-shot COVID-19 vaccine which recently received approval from the FDA. After discontinuing its own COVID vaccine development at the start of this year, Merck & Co. (known as MSD outside of North America) has formed a partnership with Johnson & Johnson (J&J) to use its facilities to manufacture the vaccine and provide a fill-finish service. “Two of the largest pharmaceutical companies in the world who are usually competitors are…

Catalent dismisses production problems in J&J COVID vaccine rollout

CDMO Catalent has refuted claims that US rollout of the recently approved J&J vaccine has been slowed down by problems at its fill-finish facilities. Shortly after the US Food and Drug Administration (FDA) approved Johnson & Johnson’s single-shot  vaccine making it the third authorized COVID vaccine  in the US, the Financial Times reported that Catalent is suffering production problems that “have contributed to the US government being set to receive millions fewer doses than it expected this month.” The British…

MilliporeSigma to manufacture biologics for Alteogen

South Korean firm Alteogen has partnered with CDMO MilliporeSigma to develop and produce biotherapeutics and monoclonal antibody drugs. The collaboration will see MilliporeSigma (the life sciences business of Germany’s Merck KGaA) provide Alteogen with late-stage manufacturing services which includes developing and producing recombinant biologics for clinical evaluation. “This agreement supports large-volume subcutaneous administration of biologics that would otherwise be administered as an IV infusion,” said head of Process Solutions at Merck, Andrew Bulpin. “This advances Merck’s strategy of providing breakthrough,…

J&J’s single-shot COVID-19 vaccine approved by FDA

The FDA has approved J&J’s single dose COVID-19 vaccine (Ad26.COV2.S) paving the way for distribution in the US. Last week, the US Food and Drug Administration (FDA) issued Johnson & Johnson’s (J&J) adenovirus type 26 COVID-19 vaccine with Emergency Use Authorization (EUA) making it the third vaccine available to US citizens. “After a thorough analysis of the data, the FDA’s scientists and physicians have determined that the vaccine meets the FDA’s expectations for safety and effectiveness appropriate for the authorization…

Ins and outs: Changes at Moderna, ReForm Biologics, Daiichi Sankyo

Moderna has appointed executive search firm Russell Reynolds to find Tal Zaks replacement as he steps down from his position as CMO. Meanwhile, there are high level changes at ReForm Biologics and Daiichi Sankyo. Zaks has been chief medical officer (CMO) of Moderna for six years. Now with its first approved mRNA COVID-19 vaccine, Zaks will step down from his position in late September though it is unknown where he will embark on the next leg of his career. Moderna’s…

CDMO quadruples lentiviral capacity on the back of cell gene demand

VIVEbiotech has responded to the high demand for lentiviral vectors in the cell and gene therapy space by expanding its facilities. While no financial details have been disclosed, the Spanish contract development manufacturing organization (CDMO) said it is ramping up its manufacturing capacity and processes enabling it to respond to lentiviral demand. “We are based in San Sebastian in northern Spain, very close to the French border,” a spokesperson told BioProcess Insider. “Our facilities will be increased in around 3,000…