Author Archives: Millie Nelson

CDMO round-up: News from Lonza, MedPacto and Revolo Biotherapeutics

Lonza collaborates with Immunitas to develop candidate; MedPacto signs agreement with Samsung Biologics; Revolo Biotherapeutics chooses CordenPharma to manufacture its peptide and immune system resetting drug 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 Lonza, which recently entered an agreement with Immunitas Therapeutics to support manufacturing of Immunitas’ lead program, IMT-009. IMT-099 is a monoclonal antibody that suppresses NK cells and T cells in the tumor microenvironment and…

Albumedix more than doubles albumin production with expanded UK plant

Albumedix has completed expansion of its commercial-scale manufacturing facility and established new labs, doubling its albumin production capacity. After more than three years of design and construction work, Albumedix has completed the expansion of its Nottingham facility and is now able to manufacture out of this site. The expansion enables the firm to more than double its albumin production, which is used for stabilization and to deliver pharmaceuticals. “Part of the expansion included the construction of a four-storey building adjacent…

Abzena selects NC for $200m biologics plant

Abzena has selected Sanford, North Carolina as the site of a biologics manufacturing facility equipped with 12x 2,000 L bioreactors. In January, British contract development manufacturing organization (CDMO) Abzena announced the addition of a sixth global site in the US. The exact location of the plant was not divulged. However, the firm revealed this week that the site will be in Sanford, North Carolina. The Sanford facility will cost over $200 million and will be dedicated to manufacturing mammalian biologics.…

Catalent completes Wisconsin expansion and doubles its capacity

CDMO Catalent has completed an $85 million expansion at its Madison drug substance facility and has started work on customer programs. The contract development manufacturing organization (CDMO) Catalent has added two mammalian cell culture suites at its Madison facility, meaning the site has five suites in total and has more than doubled its overall capacity. The two additional suites each boast a 2 x 2,000 L single-use bioreactor system that can process batches of 2,000 L or 4,000 L for…

Ins & outs: Cavazzoni named as director of FDA’s CDER

The US FDA’s CDER  has named Patrizia Cavazzoni as its permanent director. Meanwhile, there are high level changes at Rentschler Biopharma, Bone Therapeutics, and Imvax. Sit back, relax, and enjoy BioProcess Insider’s Ins & Outs. The appointment comes after Cavazzoni has served as acting director of the US Food and Drug Administration’s Center for Drug Evaluation and Research (FDA’s CDER) for the past year after Janet Woodcock stepped away from the role to assist Operation Warp Speed (OWS) in response to…

Lonza to make Junshi Biosciences antibody at China facility

Lonza has expanded its collaboration with Junshi Biosciences to develop and manufacture an antibody candidate at its recently opened, Guangzhou facility. Swiss contract development manufacturing organization (CDMO) Lonza has extended its partnership with Chinese firm Junshi Biosciences to advance and manufacture biologics. The agreement also includes the production of an antibody candidate that will be manufactured at Lonza’s site in Guangzhou, China. Under the agreement,  Lonza will provide support to  develop and manufacture current and future antibody-based products in Junshi…

COVID-19 and cell and gene sector help to kickstart Pharma 4.0

COVID-19 and the growth of the cell and gene therapy sector have pushed the pharma industry to use new and emerging technologies to solve manufacturing challenges.    Speaking at the recent BPI West virtual conference, co-founder and CEO of Apprentice Angelo Stracquatanio said the coronavirus pandemic has forced companies across the pharma industry to adapt and operate differently, particularly altering how and what technologies it opts to use.  With business “grossly disrupted,” he argued “the industry started to turn to new and emerging technologies to solve a lot of these key challenges that came up in…

Horseshoe crabs: COVID-19 further threat to ‘blue blood’ of industry

The industry relies on horseshoe crab blood for endotoxin testing. These marine arthropods are endangered but the race to manufacture COVID-19 vaccines in large volumes is placing them under further threat. Often referred to as ‘living fossils’, horseshoe crabs have inhabited the Earth for more than 450 million years. For drugmakers, it is the horseshoe crab’s blue blood that has remained a fascination and until recently a necessity . The chemicals in the crab’s blood can react to harmful bacteria…

Catalent: ‘Dedicated Moderna line frees space for our non-COVID customers’

Catalent has dedicated a high-speed vial filling line to Moderna at its site in Indiana, which it says will free up space for its non-COVID related customers.  The high-speed vial filling line expands upon an agreement inked between the two firms last June, and provides Moderna with a dedicated fill-finish service through to June 2023. It will initially be used to manufacture Moderna’s COVID-19 vaccine, approved by the US FDA under an emergency use authorization (EUA) last December, though there is potential for it to produce other clinical products in the firm’s pipeline. According to the…

CyanVac selects Exothera to make intranasal COVID-19 vaccine

CyanVac has partnered with CDMO Exothera to develop and manufacture its intranasal COVID-19 vaccine candidate CVXGA1 using the scale-X platform. Georgia, US-based vaccine developer, CyanVac has selected contract development manufacturing organization (CDMO) Exothera to advance development of a manufacturing process for its COVID-19 vaccine candidate that is administered intranasally as a single dose to prevent SARS-CoV-2 infection. “We have been working on intranasal vaccines for over 20 years,” Biao He, CEO and founder of CyanVac told BioProcess Insider. “The viral vector…