Author Archives: Dan Stanton

Resilience cites GLP-1 demand in $225m+ fill/finish expansion

Plans to expand National Resilience’s drug product manufacturing capabilities will support the strained capacity demands for GLP-1 blockbusters. Resilience, the contract development and manufacturing organization (CDMO) in all-but-name that launched in November 2019, has laid plans to expand fill and finish facilities in Cincinnati, Ohio and Research Triangle Park (RTP), North Carolina. These will complement drug product capabilities at a site in Toronto, Canada, added through the acquisition of Therapure Biopharma’s CDMO assets in 2021. The 580,000 square-foot West Chester, Cincinnati…

Biogen expects CDMO revenues to drop as Denmark commitments end

Final production commitments from a site in Hillerød, Denmark since sold to Fujifilm brought in $230 million in contract manufacturing revenues for Biogen in 2023. For the full year 2023, Biogen reported sales of $9.8 billion, down 3% year-on-year due in part to reduced sales from the firm’s multiple sclerosis products. Rare disease and biosimilar sales remained relatively flat, but one segment that grew over the past 12 months was Biogen’s contract manufacturing business, which pulled in $899 million –…

AZ cites FasTCAR to drive speedier cell therapy production

AstraZeneca says the FasTCAR platform, added through the acquisition of Gracell last year, could reduce CAR-T manufacturing from three weeks to 22 hours. AstraZeneca substantially raised its stake in the cell therapy space in 2023, culminating in the acquisition of Chinese biopharmaceutical company Gracell Biotechnologies for $1.2 billion. The deal added Gracell’s FasTCAR manufacturing technology, which claims to significantly shorten manufacturing time for chimeric antigen receptor (CAR) T-cell therapies. The firm spoke about the acquisition and the technology on its…

Novo Catalent deal primed to shake up CGT outsourcing space

Big Pharma’s GLP-1 push has inadvertently caused the “biggest transaction of cell and gene capacity ever” and will cause ripples across the sector. M&A has long been rife among contract development and manufacturing organizations (CDMOs), but the general trend has been of consolidation in a fragmented space as companies fill holes in their outsourcing offerings. Thermo Fisher’s $7.2 billion Patheon buy in 2017 and Danaher Corporation’s $9.6 billion Aldevron takeover in 2021 demonstrate the money that service firms have been…

Novo Holdings to buy CDMO Catalent for $16.5bn

Novo Holdings will take CDMO Catalent private and sell three of its drug product manufacturing facilities to Novo Nordisk, of which it is the major shareholder. The deal, expected to close towards the end of 2024, will see Novo Holdings – a holding and investment company responsible for managing the Novo Nordisk Foundation’s assets and wealth – acquire publicly-owned contract development and manufacturing organization (CDMO) Catalent for $63.50 per share in cash, representing $16.5 billion. Kasim Kutay, CEO of Novo…

Normalization drags on but bioprocess vendors expect recovery in 2024

Bioprocessing remains muted following COVID but Thermo, Sartorius, and Danaher expect 2024 to see the end of recent volatility – outside of China at least. This week, Thermo Fisher reported full year sales within its Life Sciences Solutions unit (essentially its bioprocessing/bioproduction business) of $9.9 billion, down 26% from 2022’s $13.5 billion. A similar pattern was seen among Thermo’s peers, with Sartorius reporting sales of $2.7 billion in its Bioprocess Solutions business, down 19.5% year-on-year, and Danaher Corporation clocking in…

Sartorius eyes Korea’s booming biomanufacturing market

Sartorius has cited South Korea’s “very stable market” as a key driver in its €270 million ($292 million) investment in a production site in the region. For the full year 2023, bioprocess vendor Sartorius reported sales of €3.4 billion, down 18.7% on the previous year. This represents the continuing “soft demand” following several years of unprecedented sales during the COVID-19 pandemic and continuing macroeconomic factors, the company said. “2023 was a very unusual and challenging year for our industry,” said…

WuXi Bio shares drop as US BIOSECURE bill targets China biotech

WuXi Bio says a draft bill aimed at restricting Chinese biotech firms from accessing federal contracts contains misleading information about its CEO, Chris Chen. Introduced in the House of Representatives last week, the BIOSECURE act aims to “ensure foreign adversary biotech companies of US national security concern do not gain access to US taxpayer dollars,” according to the bipartisan Select Committee on the Chinese Communist Party. “The Government of the People’s Republic of China (PRC) seeks to dominate biotechnology as…

Kyverna: 3-day process a ‘gamechanger’ for CAR-T

Kyverna says its vein-to-vein manufacturing process brings the average CAR-T manufacturing time down from 8-10 days and offers patients an alternative to apheresis. California-based Kyverna Therapeutics published a paper in BioRxiv last week describing its proprietary manufacturing process, Ingenui-T, for chimeric antigen receptor (CAR) T-cell therapies. The process uses less than 300 ml of whole blood from a blood draw for the collection of T cells from patients instead of leukapheresis, a type of apheresis, which is the industry standard CAR-T…

Insider’s out? Evotec ‘immediately’ reported ex-CEO share trading

Biologics CDMO Evotec says it immediately disclosed share transactions made by former CEO Werner Lanthaler and has since refined its insider trading policies. After 15 years at the helm, contract development and manufacturing organization (CDMO) Evotec earlier this month announced the stepping down of Werner Lanthaler citing personal reasons. But during a business update call this week, the firm made reference to Lanthaler’s departure in combination with “his late disclosure of transactions in company shares” made over a period of…