Author Archives: Dan Stanton

Novartis to make 24m doses of Pfizer vaccine from Slovenian plant

Novartis will further support production of the Pfizer-BioNTech COVID-19 vaccine through fill-finish capabilities at its Ljubljana, Slovenia site. Earlier this year, Swiss pharma giant Novartis signed an agreement to provide aseptic manufacturing services from its Stein, Switzerland, to support the production of Pfizer and BioNTech’s COVID-19 vaccine. The arrangement was described at the time as part of the “unprecedented level of collaboration” occurring across the industry, and nine months on such collaboration continues, with Novartis signing a new agreement to…

J&J preps to enter cell therapy space as CAR-T approval decision approaches

J&J says it will learn from pioneers in the cell therapy space as it preps its production network for the potential launch of its BCMA CAR-T product. J&J division Janssen Biotech entered the cell and gene therapy space in 2017, teaming up with Legend Biotech for the development of ciltacabtagene autoleucel (cilta-cel), a chimeric antigen receptor (CAR) T-cell candidate specifically targeting the B-cell maturation antigen (BCMA) and is known as LCAR-B38M in China . Nearly four years on, and the…

Boehringer’s adalimumab becomes first interchangeable mAb biosimilar

The US FDA has approved Boehringer Ingelheim’s Cyltezo as the first biosimilar interchangeable with AbbVie’s blockbuster monoclonal antibody Humira (adalimumab). While biosimilars have offered cheaper versions of biological drugs in the US for six years, the issue of interchangeability has muddied the waters. An interchangeable biosimilar is one that can be substituted at the pharmacy level for the reference product without the prescriber having to change the prescription. Interchangeability is an additional standard beyond the requirement for biosimilarity and thus…

Fujifilm breaks ground on 160,000 L mammalian plant in NC

Fujifilm Diosynth’s CEO Martin Meeson sees no slowdown in demand for CDMO capacity across all modalities as work begins on a $1.8 billion mammalian cell culture plant in North Carolina. In March, contract development and manufacturing organization (CDMO) Fujifilm Diosynth Biotechnologies selected Holly Springs, North Carolina as the site of its latest addition to its biomanufacturing network. Construction began last week on the ¥200 billion ($1.8 billion), and once operational in 2025 it will offer biopharma customers 8 x 20,000…

Months after Cognate buy, Charles River divests plasmid DNA plant

Charles River says the divestment of a plasmid DNA CDMO facility in Sweden will help optimize its business and does not signify a U-turn in its cell and gene therapy strategy. In February this year, Charles River Laboratories agreed to pay $875 million in cash to acquire Cognate BioServices. The deal propelled the biopharma services firm into the contract development and manufacturing organization (CDMO) space, adding a network of cell therapy and plasmid DNA manufacturing facilities. The deal went through…

Avid turns to viral vector production on back of strong CGT growth

CDMO Avid Bioservices will expand its biomanufacturing services to include viral vector development and production, investing up to $75 million in a California facility. Biologics contract development and manufacturing organization (CDMO) Avid Bioservices revealed today to build a 53,000 square foot viral vector development and GMP manufacturing facility in Costa Mesa, California at a cost of between $65 million to $75 million. The facility, which could be operational within two years, will initially support projects up to 200 L using…

Aceto buffers up presence in bioprocessing with A&C buy

A&C Bio Buffer is the sixth acquisition for Aceto in the past two years and signals the firm’s ambitions in the biomanufacturing services space. The deal, financials of which have not been disclosed, brings Aceto a GMP (Good Manufacturing Practices) manufacturer of custom buffer and chemical blend products used in the manufacturing of biopharmaceutical drug products, with a facility in Limerick, Ireland producing over 50 products including biological buffers, process solutions, cleaning solutions and WFI (Water for Injection). “A&C Bio…

Lonza ups mammalian cell services in Singapore

The increased capabilities in Singapore will support both upstream and downstream processing and analytical development, the CDMO says. The size of the investment has not been disclosed, but Jeetendra Vaghjiani, senior director of Clinical Development for Mammalian Biologics, Lonza told this publication the expansion consists of a 1800 m2 lab built at the Singapore Science Park in Tuas along with the renovation of an existing 1500 m2 lab. “We are adding more capacity across all our technologies, supporting upstream and…

Simulated Bed fellows: Tosoh buys purification firm Semba

Tosoh Bioscience says it will complement its resins business through the addition of continuous chromatography firm Semba Biosciences. The deal, which closed earlier this month, saw Pennsylvania-based Tosoh add all Semba’s staff and assets for an undisclosed fee. The acquisition will boost the firm’s downstream bioproduction portfolio, made up of chromatography resins, with the addition of Semba’s simulated moving bed (SMB) chromatography systems (see text box below). “Coupled with Semba’s revolutionary multi-column chromatography technology we have found a perfect complement…

Boosters and beyond: CDMOs likely to continue to ride COVID-19 wave

Inoculating children and booster jabs will further fuel CDMO demand argues GlobalData’s Fiona Barry, who adds industry’s reliance on third-party manufacturers will not abate post-pandemic. Since the start of the pandemic, biopharma’s efforts and determination in developing and producing billions of vaccines and therapeutics have led to some companies and sectors benefitting from a COVID-19 windfall. The contract development and manufacturing organization (CDMO) sector is one such group, with both drug substance and drug product capacity proving crucial in the…