Upstream & Downstream Processing

Meissner expanding footprint with Irish gov support

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Filtration firm Meissner will establish a facility in County Mayo, Ireland for the manufacture of single-use systems, creating 150 jobs. Meissner Filtration Products has taken advantage of a 34,000 square-foot facility Advanced Technology Building, constructed by Ireland’s investment agency IDA, and plans to expand it by a further 100,000 square-feet. The firm plans to construct a cleanroom within the existing facility to be used for the manufacture of single-use systems (SUS) to support biopharmaceutical clients. Adjacent land at the site…

February 13, 2019

Thermo Fisher to make T cells for Torque at new NJ plant

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Thermo Fisher will staff and operate a modular and fully-closed cell therapy facility in New Jersey on behalf of Torque. The 10,000 square-foot facility in Princeton, New Jersey is set to come online in 2019 and will support Torque’s immuno-oncology ‘Deep-Primed T Cell’ candidates. The products use the firm’s cell process engineering technologies, which do not require genetic engineering of the T cells, and lead candidate TRQ1501 (Deep IL-15 primed T cells) is set to begin Phase I/II clinical trials…

February 6, 2019

Vendors highlight another standout year for bioprocessing

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Demand for bioprocessing technology remains strong as GE Healthcare, Thermo Fisher, Pall and Sartorius all report high annual growth. With the financial season in full swing, four of the major industry suppliers have reported their Q4s and end-of-year results, and all have one thing in common: high growth across their bioprocessing segments. GE Healthcare, which is being prepped to separate from parent company General Electric, reported revenues of $19 billion (€16.5 billion) for the full year, up 4%. The division…

February 1, 2019

Life after Lonza: Sartorius looks to build inhouse culture media biz

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After a six-year partnership with CDMO Lonza ended, Sartorius Stedim Biotech says it is looking to build its own cell culture media business. In November 2018, bioprocessing vendor Sartorius and contract development and manufacturing organization (CDMO) Lonza ended a supply and distribution partnership forged in December 2012 for media and buffers used in the manufacture of protein-based therapeutics and vaccines. Under terms of the deal, Lonza manufactured the media and Sartorius had the exclusive sales and marketing rights. Customers of…

January 30, 2019

Finding closure: Lowering the costs of cell and gene therapies

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Fully closed and automated platforms are key to reducing the current high costs of cell and gene therapy manufacturing, say industry experts. Cell and gene therapies (CGTs) have come a long way over the past two years, resulting in two chimeric antigen receptor (CAR) T-cell therapies – Kymriah and Yescarta – and the novel gene therapy Luxturna reaching commercialization. But now these therapies have proved themselves, the major talking point among delegates at the Phacilitate conference in Miami, Florida last…

January 30, 2019

Amgen completes five-year plan, sees 24% drop in facility footprint

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Amgen’s commitment to next generation biomanufacturing has led to a reduction in its facility footprint of nearly a quarter since 2013. In 2013, Amgen commenced a “company-wide re-engineering process” aimed at transforming its business to prepare for long-term growth. The restructure included significant job cuts and plans to reduce facility footprint by 23%, while ensuring increased bulk production through next-generation biomanufacturing platforms. Five years on, and David Meline, Amgen’s CFO, said the firm has successfully transformed “the business “to achieve…

January 30, 2019

Merck and MIT look to continuous cell-based vaccines in NIIMBL project

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An 18-month project partners Merck & Co. with vendor Repligen and academia to develop approaches for continuous cell-culture based vaccine manufacturing. The program, entitled ‘The Continuous Cell Culture for Viral Vaccines’ is being led by the Massachusetts Institute of Technology (MIT), will bring together Big Biopharma firm Merck & Co. (known as MSD outside North America), bioprocessing vendor Repligen, Massachusetts Life Sciences Center, and the University of Massachusetts Medical School. It is one of 22 projects recently announced by the…

January 25, 2019

Gamma Delta T GMP: TC Biopharm creates allogeneic cell banks

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TC Biopharm has formulated its first Gamma Delta T (GDT) cell banks it says provides the firm with the technology to develop next-generation allogeneic CAR-T therapies. Supported by a €4 million ($4.5 million) grant from the European Union’s Horizon 2020, Scotland, UK-based biotech TC Biopharm has completed formulation of its first GDT cell banks intended to help rapidly progress its allogeneic therapies through the clinic. “GDT cells are a subset of white blood cells and are part of the innate…

January 24, 2019

Manufacturing costs the ‘biggest threat’ to cell and gene therapies

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This is the first time in history that we can make more effective medicines than we can afford, says Dark Horse Consulting. The Phacilitate conference took place in Miami this week, and in the plenary session Anthony Davies, founder of cell and gene therapy specialist firm Dark Horse Consulting, described the latest developments in the field of regenerative medicine. With the approvals of Kymriah (tisagenlecleucel), Yescarta (axicabtagene ciloleucel) and Luxturna (voretigene neparvovec) in 2017, “this field finally had the year…

January 23, 2019

Bavarian Nordic to validate fill/finish plant using $44m US gov option

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The US Biomedical Advanced Research and Development Authority (BARDA) has exercised a second option in its smallpox vaccine contract with Bavarian Nordic. In September 2017, the US government’s Biomedical Advanced Research and Development Authority (BARDA) awarded Danish vaccine manufacturer Bavarian Nordic contract for the manufacturing and storage of its smallpox vaccine worth upwards of $539 million (€474 million). To support the agreement, BARDA exercised an option in 2017 to cover development costs associated with the Phase III study of the…

January 18, 2019