Facilities & Capacity

Another WuXi Vaccines deal? No, just a repurposed press release

Contrary to some reports, WuXi Biologics is not building a second facility for its recently formed vaccines joint venture but has merely secured the $3 billion contract announced last May. Nine months ago, WuXi Biologics and Shanghai-based Hile Bio-Technology formed WuXi Vaccines, a contract development and manufacturing organization (CDMO) to service a Letter of Intent (LOI) inked with an undisclosed multinational vaccine company. In November, plans were laid to build a $240 million (€222 million) three-story dedicated manufacturing facility in…

Audentes $109m NC expansion boon for Astellas gene therapy plans

Astellas acquisition Audentes has laid plans to build a 135,000 square-foot gene therapy manufacturing plant in Sanford, North Carolina. The $109 million (€100 million) plant is expected to be operational in 2021 and will support Audentes’ gene therapy portfolio. The firm’s lead product is AT132, a Phase I/II clinical-stage experimental treatment for X-linked myotubular myopathy (XLMTM), though the firm is also developing gene therapies for Pompe disease and Duchenne Muscular Dystrophy (DMD). “Our investment in large-scale manufacturing has always been…

Latest insulin injection sees Novo Nordisk pump $117m in Danish plant

A plant in Kalundborg that makes “around half of the world’s insulin” will benefit from another upgrade and expansion, says Novo Nordisk. Novo Nordisk’s site in Kalundborg, about 100 km west of Danish capital Copenhagen, has been making insulin products for over 50 years. The firm has heavily invested in production at the site over the past few years, and this latest expansion announced Friday sees a further DKK 800 million ($117 million) in upgrading and expanding facilities there. “Part…

With capacity stretched, GSK says limited growth for Shingrix vaccine until 2024

With demand for shingles vaccine Shingrix continuing to outstrip supply, GSK says there is limited opportunity for further growth until extra capacity comes online. Meanwhile, the firm is investing $564 million at its vaccine operations in Belgium For GlaxoSmithKline’s vaccine business, sales grew 21% year-on-year to £7.2 billion ($9.3 billion). The firm attributed this primarily to the growth in sales of Shringrix, its non-live, recombinant subunit vaccine for the prevention of shingles (herpes zoster). The vaccine has continually seen quarterly…

Celltrion pulls plant team out of Wuhan as it tracks coronavirus

Celltrion says it is committed to a biosimilars plant in Wuhan, China but has pulled project team out while it tracks the 2019-nCoV coronavirus outbreak. Celltrion is keeping a close eye on the spread of 2019-nCoV according to a spokesman. He told us “while we remain strongly committed to the project, it is difficult to say how the ongoing outbreak will affect our plans at this moment. “We are closely monitoring the situation and will continue to communicate with the…

Iovance internal network aims to tweak TIL manufacturing process

Having its own facility will help Iovance intensify manufacturing of its tumor infiltrating lymphocyte (TIL) cell therapies and help to reduce the 22-day process, the firm says. In May last year, Iovance Biotherapeutics announced plans to construct a 136,000 square-foot facility in Philadelphia, Pennsylvania for the clinical and commercial production of its autologous TIL products, including its lead candidate lifileucel in Phase II trials for metastatic melanoma. Speaking last month at the Phacilitate conference in Miami, Florida, Michelle Simpson-Abelson, principle…

Catalent to buy Orgenesis’ cell therapy CDMO biz for $315m

Last year Catalent entered the gene therapy space, now the CDMO will expand into cell therapies through the acquisition of Masthercell from Orgenesis. The deal includes a plant in Belgium and a site under construction in Texas. The deal sees contract development and manufacturing organization (CDMO) Catalent paying $315 million (€285 million) for Orgenesis’ third-party cell and gene therapy business Masthercell. Orgenesis will receive around $127 million of this with Masthercell’s backers Great Point Partners and SFPI-FPIM presumably receiving the…

‘Lack of good CDMOs’ factor for Krystal’s $90m gene therapy plant

Krystal Biotech has broken ground on a commercial gene therapy manufacturing facility in Findlay Township, Pennsylvania. The 100,000 square-foot ‘ASTRA’ facility, set to create 75 jobs in the Pennsylvanian town, is expected to open in late 2021 to support Krystal Biotech’s gene therapy pipeline. Krystal is developing several ‘off-the-shelf’ gene therapies for rare skin diseases using its Skin TARgeted Delivery (STAR-D) platform consisting of an engineered HSV-1 vector and skin optimized gene transfer technology. Lead candidate B-VEC (previously known as…

Trump tax and pipelines behind Lilly’s $470m NC injection

Eli Lilly says its injectables pipeline and Trump-era tax laws prompted the decision to build new plant in North Carolina. Earlier this week Lilly announced it would build an injectable drug manufacturing facility in Durham County, North Carolina as part of a $470 m investment. The facility located at Research Triangle park will make injectable drugs and delivery devices according to Lilly, which said it expects to create more than 460 new jobs. A Lilly spokeswoman told us “The new…

CDMO aims ‘big’ in $1.2bn push to deliver capacity to cell & gene space

The newly formed Center for Breakthrough Medicines is building what it claims to be the world’s largest third-party cell and gene production facility at an ex-GSK site in Pennsylvania. For the production of cell and gene therapies, size matters, according to Brian O’Neill, founder of the Discovery Labs. He announced this week at the Phacilitate Conference in Miami, Florida that a 680,000 square-foot facility at a site in King of Prussia, Pennsylvania – a former GSK R&D campus sold to…