Facilities & Capacity Archives - Page 34 of 73 - BioProcess InternationalBioProcess International

Novartis continues Kymriah capacity expansion with Japanese CDMO

Novartis has tripled production capacity for its commercial CAR-T therapy Kymriah over the past year and continues to ramp up through a deal with Japan’s Foundation for Biomedical Research and Innovation (FBRI). Kobe, Japan-based FBRI has received marketing authorization from Japan’s Ministry of Health, Labor and Welfare (MHLW) to manufacture Kymriah (tisagenlecleucel) for Swiss pharma giant Novartis. The approval expands the manufacturing footprint of the chimeric antigen receptor (CAR) T-cell therapy, bringing Novartis its first Asian production facility. Furthermore, according…

Catalent bones up on CGTs with Skeletal Cell Therapy buy

by Gareth Macdonald

Catalent has agreed to buy Bone Therapeutics’ manufacturing unit – Skeletal Cell Therapy Support SA – and make trial supplies of the candidate bone disease cell therapy, ALLOB. The contract development and manufacturing organization (CDMO) will pay €12 million ($14 million) for Skeletal Cell Therapy Support SA (SCTS), which operates a 3,800 square meter manufacturing facility, development lab and warehouse at the Brussels South Charleroi Biopark, in Belgium. The site produces Bone’s allogenic cell therapy candidate ALLOB, which has been…

Lilly confident in remediating troubled COVID mAb plant

by Dan Stanton

Eli Lilly has engaged an external firm to conduct a comprehensive independent review after the FDA found data integrity issues at a manufacturing facility in New Jersey. Earlier this month, Reuters broke the news that the US Food and Drug Administration (FDA) issued Eli Lilly’s Branchburg, New Jersey manufacturing site with an “Official Action Indicated” (OAI) notice. This came after an inspection in November last year found that processing data had been deleted and not appropriately reviewed by the firm’s…

Thermo Fisher: ‘$700m COVID CapEx easily repurposed post-pandemic’

by Dan Stanton

An additional $700 million capacity buildout to meet COVID-related demand will serve the longer-term non-pandemic-related biopharma market, says Thermo Fisher An unprecedented third quarter saw Thermo Fisher report a 36% rise in revenues year-on-year to $8.52 billion across all its segments. Its Life Sciences Solutions Segment – which includes its biosciences and bioproduction business units – saw a 101% rise to $3.42 billion, while its Laboratory Products and Services Segment – which includes drug manufacturing – increased by 19% to…

Swiss plant demonstrates synergies of KBI and Selexis acquisitions for JSR

by Dan Stanton

A facility in Geneva will be home to two of JSR Life Sciences acquisitions offering customers both cell line development and drug substance manufacturing. Financial details of the new facility, occupying 8,700 square meters in the Stellar 32 campus in Geneva, Switzerland, have not been divulged, but will house both biologics manufacturer KBI Biopharma and cell line developer Selexis. Both companies are owned by JSR Life Sciences, a California-headquartered firm which has been upping its presence in the bioprocess space…

Single-use tech helps give emerging biotechs flexibility says Macrogenics

by Gareth Macdonald

Flexibility is vital for growing biopharmaceutical companies says Macrogenics, which used single-use tech to accelerate development of its Phase III manufacturing plant. Like many younger biotechnology companies, Macrogenics initially focused on product development rather than investing in production capacity. The Maryland firm was incorporated in 2000, however, it did not set up its first manufacturing facility until 2005. The plant was designed to manufacture candidates for Phase I/II trials and had limited capacity. Initially it could only carry out four…

Filling up: Thermo Fisher plans $130m Singapore plant

by Dan Stanton

Thermo Fisher will add two filling lines in Singapore to support growing demand for sterile injectables. The $130 million facility will be established with the support of the Singapore Economic Development Board (EDB) and operated by Thermo Fisher. “Thermo Fisher will be building out and operating a new facility that will serve as a new regional steriles manufacturing site for our customers and, in addition, will provide priority access to the Singapore government during future health emergencies,” a Thermo Fisher…

Ocugen signs deal with Indian CMO to avoid US capacity constraints

by Ben Hargreaves

Ocugen has signed a manufacturing deal with Kemwell Biopharma for a potential treatment of retinal diseases. The two companies entered the agreement for the clinical production of Ocu200, a novel biologic candidate that could enter clinical trials in 2022. Ocu200 will first be tested to treat diabetic macular edema (DME), but Ocugen also stated that, depending on clinical success, it could seek to expand treatment targets to diabetes retinopathy and wet-age related macular degeneration. The potential therapy is a novel…

Lusk for life: Abzena $60m plant to support Ph III and commercial biologics

by Dan Stanton

Abzena has begun operations at its 50,000 square-foot ‘Lusk’ facility boasting single-use bioreactors up to 2,000 L to support late-stage and commercial biologics. Contract development and manufacturing organization (CDMO) Abzena has further expanded its biologics offering, opening a $60 million facility in San Diego, California. The site houses a process development laboratory, two cGMP manufacturing cleanrooms for 500 L and 2,000 L scale bioreactors, a GMP warehouse, and analytical development and quality control (QC) laboratories. “We are already operational and…

Lilly hires Fujifilm Diosynth Biotechnologies to make COVID-19 mAbs

by Gareth Macdonald

Eli Lilly has added Fujifilm Diosynth Biotechnologies to the list of firms manufacturing its candidate COVID-19 antibody therapies. The contract – which is part of Lilly’s agreement with the Bill & Melinda Gates Foundation – will see Fujifilm Diosynth Biotechnologies make commercial supplies of the product at its facility in Hillerod, Denmark. Production is expected to start in April next year. The facility – which was acquired from Biogen last year – houses six 20,000 L bioreactors for the production…