Facilities & Capacity

Lack of AAV capacity drives $120m investment for Forge Biologics

Forge Biologics has closed $120 million in Series B financing to expand its AAV manufacturing capabilities and develop gene therapies. The gene therapy contract development manufacturing organization (CDMO) Forge Biologics has raised $120 million with finances led by RA Capital Management, Octagon Capital, Surveyor Capital (a Citadel company), and Marshall Wace. According to Forge, the funding will fast-track the expansion of its adeno-associated virus (AAV) manufacturing CDMO capabilities and capacity and work with its subsidiaries that are developing AAV gene…

GMP deficiencies disrupt production of ERC’s cell-based vaccine

European regulators have suspended the distribution of autologous and allogeneic cell-based vaccine candidate Gliovac following an inspection at ERC’s site in The Netherlands. The inspection took place on February 25 at the Schaijk facility, located about 75 miles southeast from Amsterdam, and resulted in a statement of non-compliance with good manufacturing practice (GMP) being issued. “ERC The Netherlands B.V. showed a lack of ability to adhere to the principles of Good Manufacturing Practice for ATMPs [advanced therapy medicinal products],” the…

Emergent recognized cross contamination risk at Bayview plant hit with 483

Emergent BioSolutions has defended the manufacture of two different viral products from its Bayview facility as part of the “Herculean task” of tackling the coronavirus pandemic. The Bayview, Maryland drug substance facility has been on the forefront of the fight against COVID-19, with Emergent BioSolutions contracted to make millions of doses of Johnson & Johnson and AstraZeneca’s respective vaccines from the plant. But an ingredient mix up reported in March rendered 15 million doses unusable, and Emergent has now halted…

Lonza’s alleged need for Nestlé staff highlights shortage in biopharma talent

Neither company will confirm reports that Nestlé staff have been commandeered to help Lonza service its Moderna contract but the story highlights biomanufacturing staffing issues. A report by Reuters this week claims contract development and manufacturing organization (CDMO) Lonza is adding staff from fellow Swiss firm Nestlé in order to service a deal to produce drug substance for hundreds of millions of doses of Moderna’s COVID-19 vaccine. The “call for volunteers” following an intervention by the Swiss government aims at…

Moderna invests to increase global COVID-19 vaccine supply

Moderna will make additional investments to increase global supply of its COVID-19 vaccine to potentially three billion doses in 2022. While no financial details of the investment have been divulged, the firm has confirmed it will provide additional funding to increase supply at its partnered and owned manufacturing sites this year with production expected to grow in late 2021 and early 2022. The increased investment will double drug substance manufacturing at CDMO Lonza’s plant in Visp, Switzerland. Lonza partnered with…

Sanofi to fill-finish up to 200m doses of Moderna’s COVID vaccine

Sanofi will supply fill-finish services for up to 200 million doses of Moderna’s COVID-19 vaccine mRNA-1273. French pharma giant Sanofi will use its site in Ridgefield, New Jersey to support manufacturing of Moderna’s cell-free COVID-19 vaccine, 1273, approved under Food and Drug Administration (FDA) emergency authorization. According to the firm, it could help manufacture up to 200 million doses of the COVID-19 vaccine starting from September 2021 through to April 2022. “While our utmost priority remains to advance our two COVID-19 vaccine…

Regeneron rejigs plans to build preclinical facility in NY state

Regeneron is reportedly injecting $480 million in a planned expansion at its campus in Greenburgh, New York including a preclinical manufacturing facility. According to various publications such as Westfair Online and Real Estate In-depth, Regeneron has designed a $480 million preclinical manufacturing facility at its Tarrytown campus in New York and proposed it to Westchester County’s Industrial Development Agency (IDA). The reported plan to build a 207,000 square-foot laboratory is said to have been amended from an initial proposal that…

BMS to build fifth cell therapy plant in response to CAR-T success

After recent CAR-T cell therapy success, Bristol-Myers Squibb will build its fifth advanced therapy manufacturing plant in Leiden, The Netherlands. The biopharma giant has invested in its fifth cell therapy manufacturing plant in Leiden, Netherlands. The plant will be its first in Europe alongside global manufacturing partnerships. The investment is part of its continued commitment to growing its cell therapy franchise and patients with haematological cancers. “At the heart of Bristol Myers Squibb’s commitment to cell therapy is our continuous…

Bayer confirms $200m Berkeley cell therapy facility

The Cell Therapy Launch Facility will support Bayer’s growing advanced therapy ambitions and comes in addition to a $1.2 billion investment in the Californian campus. Bayer has confirmed it is expanding its cell and gene capabilities through the addition of a Cell Therapy Launch Facility, which is set to join a Cell Culture Technology Center (CCTC) and Cell & Gene Therapy labs coming on-line later this year at its 46-acre campus in Berkeley, California. “The Cell Therapy Launch Facility is…

Evotec to build $180m European biomanufacturing plant

Evotec is set to build its second biomanufacturing J.POD facility at Campus Curie in Toulouse, France. The French facility will be Evotec’s first commercial biomanufacturing plant in Europe, with construction expected to begin during the second half of this year and the site anticipated to be fully operational in 2023. The firm will receive up to €50 million ($60m) from the French government, the Occitanie Region, the Haute-Garonne prefecture, Bpifrance, and Toulouse Métropole. However, the total investment is currently calculated…