Author Archives: Dan Stanton

Podcast: Life beyond Provenge as Dendreon enters CDMO world

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As Dendreon secures its first manufacturing deal, we speak with VP of corporate strategy about the firm’s new direction in the cell therapy CDMO space. Dendreon Pharmaceuticals will provide process development, end-to-end logistics, and scalable cGMP manufacturing support for Shoreline Biosciences’s pipeline of allogeneic natural killer (NK) and macrophage cellular immunotherapies derived from induced pluripotent stem cells (iPSC). Financials have not been disclosed but the deal marks the first contract announced by Dendreon since it relaunched itself as a contract…

November 8, 2021

Emergent taking $180m hit as US Gov scraps CDMO contract

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The US Department of Health and Human Services has terminated a long-term CDMO partnership with Emergent BioSolutions, which included a $628 million deal to produce COVID-19 vaccines. In 2012, Emergent BioSolutions entered into a public-private partnership for pandemic preparedness with the Biomedical Advanced Research and Development Authority (BARDA), part of the US Department of Health and Human Services (HHS). When COVID-19 hit, the partnership was expanded with Emergent receiving $628 million as part of the federal government’s pandemic response Operation…

November 5, 2021

Bionova opens $25m single-use plant in Fremont

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Bionova’s 2,000 L scale facility in Fremont, California marks a full transition to a contract development and manufacturing organization (CDMO) for the bioservices firm. In July 2020, Bionova broke ground on the $25 million Fremont facility with an aim to expand its protein, cell line, and process development services into the clinical and commercial manufacturing space. Fifteen months on and the company has officially opened the plant with the first clinical supply run expected to be completed before the end…

November 4, 2021

Spurred by CDMOs, global mammalian capacity to reach 7,500kL by 2025

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According to a report, almost half (44%) of mammalian biomanufacturing capacity will be controlled by contract manufacturers or hybrid firms by 2025, a jump from 32% in 2020. The paper entitled ‘Supply and Demand Trends: Mammalian Biomanufacturing Industry Overview,’ produced by BioProcess Technology Group BDO, forms part of the CPhI Pharma Annual Report, published ahead of next week’s event in Milan, Italy. The authors Dawn Ecker and Patricia Seymour claim that the projected kilogram quantities of product needed to meet…

November 4, 2021

With quality issues fixed, Takeda preps Hikari plant for COVID vax production

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Having in-licensed a COVID-19 vaccine from Novavax, Takeda will manufacture up to 250 million doses per year from its Hikari, Japan facility, freshly absolved by the US FDA. In June 2020, the US Food and Drug Administration (FDA) issued Takeda’s Hikari facility – located 40 km southwest of Hiroshima – a warning letter after inspectors identified issues with the plant’s Quality Unit (QU), including concerns about how the firm investigated unexplained discrepancy and batch failures – specifically the detection of…

November 3, 2021

Climate crisis: Big Pharma lays out its green credentials

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As global leaders assemble at the COP26 meeting in Glasgow, we take a look at how Big Pharma is addressing environmental governance and how the top firms perform against their peers. Another quarter down, and another bout of pharma firms describe their financial successes and woes. But a number of companies have described their efforts to look after the environment, perhaps spurred on by COP26, the UN Climate Change Conference taking place in Glasgow, UK this week. UK pharma giant…

November 2, 2021

Novartis to make 24m doses of Pfizer vaccine from Slovenian plant

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Novartis will further support production of the Pfizer-BioNTech COVID-19 vaccine through fill-finish capabilities at its Ljubljana, Slovenia site. Earlier this year, Swiss pharma giant Novartis signed an agreement to provide aseptic manufacturing services from its Stein, Switzerland, to support the production of Pfizer and BioNTech’s COVID-19 vaccine. The arrangement was described at the time as part of the “unprecedented level of collaboration†occurring across the industry, and nine months on such collaboration continues, with Novartis signing a new agreement to…

October 21, 2021

J&J preps to enter cell therapy space as CAR-T approval decision approaches

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J&J says it will learn from pioneers in the cell therapy space as it preps its production network for the potential launch of its BCMA CAR-T product. J&J division Janssen Biotech entered the cell and gene therapy space in 2017, teaming up with Legend Biotech for the development of ciltacabtagene autoleucel (cilta-cel), a chimeric antigen receptor (CAR) T-cell candidate specifically targeting the B-cell maturation antigen (BCMA) and is known as LCAR-B38M in China . Nearly four years on, and the…

October 21, 2021

Boehringer’s adalimumab becomes first interchangeable mAb biosimilar

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The US FDA has approved Boehringer Ingelheim’s Cyltezo as the first biosimilar interchangeable with AbbVie’s blockbuster monoclonal antibody Humira (adalimumab). While biosimilars have offered cheaper versions of biological drugs in the US for six years, the issue of interchangeability has muddied the waters. An interchangeable biosimilar is one that can be substituted at the pharmacy level for the reference product without the prescriber having to change the prescription. Interchangeability is an additional standard beyond the requirement for biosimilarity and thus…

October 20, 2021

Fujifilm breaks ground on 160,000 L mammalian plant in NC

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Fujifilm Diosynth’s CEO Martin Meeson sees no slowdown in demand for CDMO capacity across all modalities as work begins on a $1.8 billion mammalian cell culture plant in North Carolina. In March, contract development and manufacturing organization (CDMO) Fujifilm Diosynth Biotechnologies selected Holly Springs, North Carolina as the site of its latest addition to its biomanufacturing network. Construction began last week on the Â¥200 billion ($1.8 billion), and once operational in 2025 it will offer biopharma customers 8 x 20,000…

October 18, 2021