Therapeutic Class

Hitachi brings cell therapy biz to Europe through $86m apceth buy

Hitachi Chemical will add two production plants and 600m2 of cleanroom through the acquisition of German cell therapy manufacturing firm apceth Biopharma. The deal, expected to close in April, sees Japanese firm Hitachi acquire all shares of apceth for JPY 9.4 billion ($86 million) from Santo Holding GmbH, FCP Biotech Holding GmbH and other individual shareholders. apceth has around 120 employees operating from its site in Munich, Germany. The site includes two GMP/BSL2 cell and gene therapy production facilities, including…

Finding closure: Lowering the costs of cell and gene therapies

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…

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

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…

Phacilitate: Cell & gene industry flocks to Miami

The cell and gene therapy industry congregated in Miami to discuss supply chain strategies, regulatory rationale and the high manufacturing costs of advanced therapies. BioProcess Insider attended the Phacilitate Leaders World Summit, co-located with the World Stem Cell Summit, in Miami, Florida last week. The conference reflected on the first full year where three advanced therapies – Kymriah, Yescarta, and Luxturna – proved themselves on the commercial stage, heralding in a new frontier for regenerative medicines. But industry quickly rose above…

Gamma Delta T GMP: TC Biopharm creates allogeneic cell banks

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…

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

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…

Lower infliximab revenues but J&J still holds 93% share

There have been two infliximab biosimilars available in the US for over a year, but Johnson & Johnson says reference biologic Remicade still holds a 93% volume share. In 2016, Pfizer launched Inflectra in the US. The following year, Merck & Co. launched Renflexis. With the ensuing price war, the infliximab biosimilars had been touted to end reference biologic Remicade’s market dominance. But after the first full year with all three infliximab products on the market, J&J has reported in…

Alvotech raises $300m to advance biosimilar pipeline

After building out its manufacturing network, Iceland-based biosimilar developer has raised $300 million to support biosimilar R&D through a private bond offering. “A unit of Morgan Stanley from London was the lead investor acquiring approximately 75% of the total,” Alvotech pokesperson Halldor Kristmannsson told BioProcess Insider. “They in turn syndicated the majority of this to a small number of institutional investors.” While Kristmannsson could not disclose the actual names of those investors, he said the remaining bonds were purchased by a combination…

COGS factor in Amgen’s exit from $540m Advaxis deal

Advaxis says Amgen’s withdrawal from a 2016 personalized immuno-oncology partnership is due to portfolio rationalization, high cost of goods, and the high-risk of commercialization. In 2016, Amgen teamed up with New Jersey-based Advaxis to co-develop and commercialize Advaxis’ investigational cancer immunotherapy ADXS-NEO in a deal worth up to $540 million (€475 million). But after paying out $78 million, Amgen sent written notice last month alerting Advaxis it is terminating the partnership, effective from February 8, said Advexis in an SEC…

Trastuzumab triple: FDA approves Merck and Samsung Bioepis biosimilar

The FDA has approved Ontruzant, the third version of Roche’s cancer drug Herceptin, and the second US biosimilar approval for Samsung Bioepis. The product will be marketed by Merck & Co. Europe approved Ontruzant in November 2017 as a biosimilar to Roche’s Herceptin (trastuzumab), and 14 months on the US Food and Drug Administration (FDA) has given the oncology biologic the regulatory thumbs up. Ontruzant becomes the seventeenth biosimilar to be approved in the US, and the first of 2019.…