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…
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…
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…
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…
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…
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…
Thermo Fisher claims to be the “leading outsource provider of viral vector manufacturing,†nine months after entering the space through the acquisition of Brammer. In March 2019, Thermo Fisher expanded its presence in the CDMO space by announcing plans to buy viral vector manufacturer Brammer Bio. Weeks later, the $1.7 billion deal closed, propelling Thermo Fisher into the gene therapy manufacturing space. Nine months on and Thermo Fisher CEO Marc Casper said the business has “got off to a good…
Celltrion has confirmed it will build a biosimilars plant in China and may merge its healthcare and pharma units. A spokesman told Bioprocess Insider: “Celltrion plans to build a plant in China in a move to directly advance into the world’s second-largest biopharmaceutical market. Celltrion signed a business agreement with the city government of Wuhan and the provincial government of Hubei Province on 20 January 2020. “The company’s business roadmap centers on building a plant with a production capacity of…
Genetic disease-focused firms need infrastructure says Sarepta, which shared plans for a gene editing center of excellence at the JP Morgan healthcare conference. The gene editing center will be in Durham, North Carolina according to CEO Douglas Ingram, who said investing in capacity and knowhow is key to Sarepta’s longevity. “If one is going to be an enduring genetic medicine company, we are going to need infrastructure,†he said, citing partnerships as an important part of the expansion. “We’re deepening…
WuXi Biologics has leased a drug product plant in Leverkusen, Germany from Bayer and is in negotiations to continue making hemophilia therapy Kovaltry for the Big Biopharma firm. The lease agreement – financials of which have not been divulged – gives Chinese contract development and manufacturing organization (CDMO) WuXi Biologics its first drug product facility outside of Europe. WuXi Biologics has been rampant in building up its manufacturing network, and while it has so far focused on constructing sites, the…