Author Archives: Dan Stanton

Swiss site opens to boost Novartis CAR-T production

Novartis has opened a CHF 90 million ($91 million) manufacturing site in Stein, Switzerland to support its cell and gene portfolio. In August 2018, Novartis announced a Swiss facility would support production for its burgeoning chimeric antigen receptor T cell (CAR-T) products and pledged CHF 90 million in phased investments to support the project. The facility in Stein, about 20km east of Basel, opened its door last week ahead of the predicted 2020 date, bolstering the firm’s global network. “The…

Astellas: Large-scale gene therapy plant major driver in $3bn Audentes deal

Gaining clinical and commercial manufacturing capabilities through the acquisition of Audentes will reduce reliance on third-party manufacturers in the gene therapy space, Astellas says. Japan’s Astellas increased its presence in the gene therapy space yesterday by announcing plans to buy San Francisco-based Audentes Therapeutics for approximately $3 billion (€2.7 billion) in cash. The deal, expected to close in the first quarter 2020, will add Audentes’ lead candidate AT132 – a Phase I/II clinical-stage experimental treatment for X-linked myotubular myopathy (XLMTM)…

Thermo Fisher expands viral vector services in MA and FL

Thermo Fisher expanded plant in Florida and will open a site in Lexington, Massachusetts as part of plans to invest $125 million in its gene therapy capabilities following the acquisition of Brammer Bio. The life sciences firm has completed a $6 million (€5.5 million) expansion at its Alachua, Florida facility, doubling laboratory and warehousing capacity for upstream process development and quality control testing of gene therapy products at the site. “The expansion of this site will allow for more at…

Saint-Gobain completes Florida plant as part of $77m global expansion

French vendor Saint-Gobain has completed construction of a tubing plant in Florida, the second of seven manufacturing expansions intended to support the rapidly growing bioprocess space. The 80,000 square-foot facility in Largo, Florida is set to increase Saint-Gobain’s manufacturing capacity for its C-Flex tubing and assemblies used in fluid management for biomanufacturing. The plant, which is soon to be operational, has created up to 20 new jobs. But for Saint-Gobain, the facility completion marks the second part of seven of…

CBMG hopes to bring China success to Maryland but is it late to the CAR-T party?

Cellular Biomedicine Group (CBMG) says it hopes to leverage R&D work done in China to expedite clinical trials in the US as it establishes facilities in Maryland. Last month, Cellular Biomedicine Group, Inc. (NASDAQ: CBMG) announced plans to build a 22,000 square foot facility in Rockville, Maryland. The site will be the first outside China for the firm and is intended to initially support US clinical trials for its cell-based candidates targeting hematological indications. Speaking on its Q3 2019 conference…

GE bolsters off-the-shelf facility offering in Pharmadule deal

GE Healthcare has entered into a partnership with Pharmadule Morimatsu to optimize and expand supply of its off-the-shelf biomanufacturing platform, KUBio. Demand for modular off-the-shelf manufacturing platforms is high, due to the speed of construction and operation, flexible use, and capital cost-saving. One of the suppliers of such technologies is GE Healthcare, which touts its KUBio platform as a “factory in a box,” capable of producing biologics, vaccines, viral vector-based therapies, and other modalities. Now the bioprocess vendor has teamed…

WuXi Vaccines invests $240m in plant at ‘Ireland’s largest construction site’

The newly formed vaccines subsidiary of CDMO WuXi Biologics will create 200 jobs at a site in County Louth, Ireland. Bioprocess Insider reported last month that WuXi Vaccines – a joint venture between WuXi Biologics and Hile Bio-Technology – had applied for planning permission to build a three-storey manufacturing facility in Dundalk, County Louth. Now the firm and Ireland’s Industrial Development Authority (IDA) have revealed the level of investment in the vaccine facility will be $240 million (€218 million) and…

China: Stainless-steel will shine as market moves to commercial

There has been a barrage of investment in flexible single-use capacity in the burgeoning China market. But as the sector matures and projects move to commercial, developers are likely to opt for fixed stainless-steel facilities, says BioPlan Associates. Biomanufacturing in China is blossoming, driven by changing regulations and a surge in investment, which have created a pathway for Market Authorization Holders (MAHs) and domestic third-party manufacturers alike. In the recent CPhI Worldwide annual report, Vicky Qing XIA, senior project manager…

Indie 400: Eli Lilly cites tax reform in latest biomanufacturing expansion

Eli Lilly will expand biomanufacturing capacity at its site in Indianapolis. US tax reform stoked the $400 million (€362 million) investment, the firm says. The investment at the Lilly Technology Center campus in Indianapolis, Indiana will be used to support the production of Lilly’s diabetes medicines, adding capacity and technology upgrades to its active ingredient, syringe filling, device assembly and packaging operations. “These investments will enhance our existing facilities that make insulin, provide additional capacity for our growing portfolio of…

MilliporeSigma: Over 90% growth comes from mAbs, despite new modality momentum

MilliporeSigma is seeing “terrific momentum” from the burgeoning cell and gene therapy space, but says double-digit growth continues to be driven by monoclonal antibodies (mAbs). The recent buzz in biopharma has been around the cell and gene therapy space, along with other modalities such as mRNA. It is no surprise that news outlets, such as this one, focus on ‘new’ modalities such as cell therapies, gene therapies, and mRNA. These are touted as the next-generation in treating and curing diseases,…