Author Archives: Dan Stanton

Terumo BCT launches hollow-fiber perfusion bioreactor for CGT

Terumo Blood and Cell Technologies (BCT) has launched the Quantum Flex Cell Expansion System, saying healthier cells and scalability are among the benefits the bioreactor platform will bring to cell and gene therapy makers. According to the firm, the Quantum Flex system was based on industry’s need for earlier automation to potentially limit additional and time-consuming steps such as bridging studies and technology transfers. Furthermore, the system allows developers to complete early process development on the same platform they will…

Valneva and IDT Biologika end COVID vaccine CDMO contract

Valneva has ended its manufacturing partnership with IDT Biologika following a reduction in demand for its COVID-19 vaccine VLA2001 from the European Commission. In November 2021, French vaccine developer Valneva signed an advance Purchase Agreement (APA) with the European Commission (EC) to supply up to 60 million doses of its inactivated COVID-19 vaccine candidate, VLA2001, over a two period. Valneva was set to deliver 24.3 million doses during the second and third quarters of 2022, with contract development and manufacturing…

Danaher merging Cytiva and Pall to create $7.5bn bioprocess juggernaut

Combining Cytiva and Pall will create the “broadest” and “deepest” bioprocess product portfolio in the industry, says Danaher Corporation. The decision to create ‘The Biotechnology Group’ by merging Danaher’s two bioprocess businesses was announced at the firm’s 2022 Investor & Analyst event last week. Introducing the combined entity, Danaher CEO Rainer Blair told stakeholders the decision represents the third phase in his company’s acquisitional strategy in the bioprocess space, having first acquired and “carved out” the two businesses – Pall…

Thermo Fisher opens $160m MA purification tech plant

As part of a multiyear $650 million CAPEX spend across its bioprocessing business, Thermo Fisher has brought an 85,000 square-foot purification product plant online. The facility in Chelmsford, Massachusetts opened its doors this week, and is set to supply biomanufacturing customers with downstream technologies, specifically for the purification of biologics and vaccines. “This market continues to grow and the world’s leading biopharmaceutical companies depend on our technologies, services and expertise to help deliver life changing therapies to patients,” said Jean…

Celyad plant buy to accelerate growth for cell therapy CDMO Cellistic

Cellistic has agreed to buy Celyad Oncology’s capabilities in Mont-Saint-Guibert, Belgium to support its “rapidly growing” allogeneic iPSC manufacturing business. The deal will see Cellistic, the cell therapy contract development and manufacturing organization (CDMO) business of Ncardia BV, add the 11,000 square-foot facility located in Mont-Saint-Guibert – around 25km southwest of Brussels – from CAR-T developer Celyad. The site achieved GMP approval back in 2012 when Celyad was known as Cardio3 BioSciences. “The purchase price for the assets in the…

Bluebird Skysona approval: ‘A resurgence for HSC gene therapy’

The US approval of bluebird bio’s Skysona (eli-cel) marks a resurgence for the wider hematopoietic stem cell (HSC) gene therapy sector, says AVROBIO. Following the endorsement by an Advisory Committee in June, the US Food and Drug Administration (FDA) granted approval of bluebird bio’s Skysona (elivaldogene autotemcel, or eli-cel) Friday for the treatment of active cerebral adrenoleukodystrophy (CALD). Skysona uses ex vivo transduction with a Lenti-D lentiviral vector (LVV) to add functional copies of the ABCD1 gene into a patient’s…

AbbVie: Manufacturing consistency will affect Humira biosimilar uptake

AbbVie says payors will look to consistent global supply as a key differentiator among the many Humira biosimilar makers poised to enter the US market. AbbVie’s autoimmune monoclonal antibody (mAb) Humira (adalimumab) is the bestselling drug of all time, clocking in over $193 billion for AbbVie (and previously Abbott) since its launch in 2003 to the end of 2021. Last year alone it pulled in $20.7 billion (though lost out to the industry’s top seller spot due to $36.9 billion…

BMS confident Breyanzi capacity issues will be resolved in 2023

Bristol Myers Squibb will apply the same strategy used to increase Abecma supply to increase capacity for Breyanzi as it pushes back projected timelines into next year. Bristol Myers Squibb (BMS) has with its chimeric antigen receptor (CAR) T-cell therapy Breyanzi (liso-cel) “a best-in-class profile,” Christopher Boerner, EVP & chief commercialization officer told stakeholders at the Morgan Stanley Global Healthcare Conference last week. Having been approved in February 2021 for Large B-cell Lymphoma, the therapy won second-line approval for relapsed…

Rubius weighs up RI plant sale as part of pipeline restructure

Rubius Therapeutics will also cut 75% of its staff as it discontinues its solid tumor programs in favor of developing a next-generation red blood cell-based cell conjugation platform. Massachusetts-based Rubius announced yesterday it is scrapping clinical programs RTX-240 and RTX-224 for solid tumors and instead focusing on improving the efficacy of the tech platform they were based on. “Following careful review of recent technical progress in an alternative format for making Red Cell Therapeutics, we believe that this process has…

Novartis looks beyond mAbs with $270m manufacturing spending spree

Novartis is making a multi-year investment across three European manufacturing sites to support a growing early-stage pipeline of next-generation biologics. Pharma giant Novartis announced the investments this week, with facilities in Switzerland, Slovenia, and Austria set to see increased drug substance and drug product capabilities. Specifically, $110 million will be injected in clinical manufacturing and technical development capabilities at the firm’s Mengeš, Slovenia site, while $60 million will be used to add technical manufacturing capacity at the Schaftenau campus in…