With a surge of gene therapies coming through the clinic and a lack of CDMO capacity, having inhouse capabilities is driving investment and M&A activity. As increasing numbers of gene therapies progress through the clinic and towards commercialization, it is no secret that demand for production capabilities is high. The complexity and cost of making viral vector means is a problem, but a biopharma with its own capabilities holds a major advantage, it would appear, something Pfizer CSO Mikael Dolsten…
Facilities & Capacity
Agilent aims to double oligo sales as CO plant comes into play
Agilent Technologies says it hopes to bring in $200 million in oligonucleotide revenues as it ramps up capacity to serve the growing RNAi sector. Agilent Technologies gained a nucleic acid active pharmaceutical ingredients (API) manufacturing base in Frederick, near Boulder, Colorado, in 2006 when it acquired SynPro Corp. In 2016, the life sciences technology and services firm announced plans to double its oligonucleotide capacity through a new $120 million (€108 million) facility at the site. At the Evercore ISI HealthCONx…
Merck plans $57m NC investment to support rotavirus vaccine
The investment at the facility in Wilson, North Carolina comes on the back of several expansion across Merck & Co’s vaccine manufacturing network. Merck (known as MSD outside of North America) announced just five months ago plans to invest $680 million (€613 million) to ramp up its vaccine production capabilities in North Carolina to support human papillomavirus (HPV) vaccines Gardasil and Gardasil 9. The expansion plans included a $30 million investment to add packaging lines and warehouse space at Merck’s…
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…
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…