Author Archives: Dan Stanton

Danaher entering pureplay CDMO space in $9.6bn Aldevron buy

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Danaher Corporation will add protein production, plasmid DNA, and mRNA services to its bulging life sciences portfolio through the acquisition of Aldevron. The deal will see Danaher Corporation buy North Dakota-headquartered contract development and manufacturing organization (CDMO) Aldevron from private equity firm EQT for $9.6 billion. The business will operate as a standalone within Danaher’s Life Sciences segment, which includes such businesses as bioprocessing firms Pall Corporation and Cytiva, bought for $13.8 billion and $21 billion, respectively. Through the acquisition,…

June 18, 2021

Dendreon leveraging Provenge network to launch cell therapy CDMO biz

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Dendreon says its experience bringing Provenge to market puts it in good stead to offer its process development, manufacturing, and patient logistics capabilities to other cell therapy makers. Dendreon has had a turbulent past. Its autologous cell therapy product Provenge (sipuleucel-T) was approved in the US in 2010 for the treatment of prostate cancer but manufacturing complexities and costs led the firm to restructure itself in 2012, including selling its Morris Plains, New Jersey to Novartis. Then in 2014 Dendreon…

June 17, 2021

Jubilant HollisterStier $92m fill/finish expansion, wins Ocugen Covaxin contract

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CDMO Jubilant HollisterStier will supply Indian COVID-19 vaccine Covaxin from its sterile injectable site in Spokane, Washington, currently undergoing a capacity expansion. Covaxin, developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR), is a highly purified and inactivated vaccine manufactured using a vero cell manufacturing platform. Philadelphia-based biotech Ocugen is working with Bharat to bring the vaccine in Canada and the US and has selected contract development and manufacturing organization (CDMO) Jubilant HollisterStier to help…

June 17, 2021

Beyond the CDMO: Samsung Biologics reveals Big Pharma ambition

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Having grown into one of the world’s largest bio-CDMOs over the past decade, Samsung Biologics says its next step is to become a top tier pharmaceutical company. Incheon, Korea-based contract development and manufacturing organization (CDMO) Samsung Biologics boasts three plants hosting a total of 364,000 L of mostly stainless-steel bioreactor capacity. Last year, the firm began construction on a fourth facility, housing an additional 256,000 liters of mammalian production capacity as well as fill/finish capabilities. “it’s going to be delivered…

June 16, 2021

Finnish CDMO Biovian to make oncolytic virus candidate for Lokon

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Lokon Pharma has selected CDMO Biovian to produce its oncolytic adenovirus candidate LOAd703 from its viral vector plant in Turku, Finland. LOAd703 (delolimogene mupadenorepvec) is the first clinical candidate from Lokon Pharma’s platform expressing TMZ-CD40L and 4-1BBL, two potent stimulators of dendritic cells as well as of T and NK cells, which play key roles in the induction of immune response against cancer cells and supporting stroma. To support various oncology clinical trials, the firm has inked a deal with…

June 15, 2021

CDMO Yposkesi adding two viral vector lines in $71m expansion

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With Korean investment firm SK Holdings on board, CDMO Yposkesi is building a second commercial manufacturing plant to support the burgeoning gene therapy sector. Contract development and manufacturing organization (CDMO) Yposekesi announced ‘project SKY’ today, investing €58 million ($71 million) in a 50,000 square-foot facility at its site in Corbeil-Essonnes, France – about 40 km south of Paris. Once complete in 2023, the facility will double the CDMO’s production capacity for drug substance of viral vectors and make the Corbeil-Essonnes…

June 14, 2021

Big Pharma collaborative trend to continue beyond COVID

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Manufacturing collaboration between traditional rivals will be normal post-pandemic say GSK and Merck & Co., both of which are using their capacity to support fellow Big Pharma COVID-19 efforts. The biopharma space has traditionally been a highly competitive arena. Retaining intellectual property through secrecy, litigation, and other means is crucial to ensure maximum revenues from products developed at high-cost and high-risk. Just look at how the entrance of biosimilars have decimated certain company’s top line results. But a new era…

June 11, 2021

Vibalogics plans $50m expansion as viral CDMO demand sits at ‘all-time high’

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Investment in oncolytic viruses, viral vaccines, and viral vector gene therapies have driven CDMO Vibalogics to expand its capabilities in Germany. Contract development and manufacturing organization (CDMO) Vibalogics will pump $50 million into its Cuxhaven, Germany facility to expand early-to-late phase clinical virotherapy manufacturing capacity. According to the firm, it has seen a growing customer base comprised of Big Pharma, start-ups, and mid-sized biotechs requiring viral vectors for a range of pipeline modalities. “The work we are doing in support…

June 11, 2021

J&J: ‘We’re working with – but not dependent on – Emergent’

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Talks are ongoing with troubled CDMO Emergent, but a robust production network means J&J is still on track to produce a billion doses of its COVID vaccine this year. In February, Johnson & Johnson (J&J) became the third firm to receive Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for a COVID-19 vaccine. The single shot offering received European authorization the following month. However, the vaccine has hit several snags. Questions around potential blood clots saw…

June 9, 2021

Biogen Alzheimer’s mAb approval to be a boon for bioprocess space

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The approval of Aduhelm (aducanumab) will have a significant knock-on effect for the bioproduction services space, increasing the annual growth rate several percentage points. Yesterday, the US Food and Drug Administration approved Aduhelm ending years of regulatory turbulence for Biogen. The drug, a monoclonal antibody that breaks down amyloid plaque buildup that is thought to worsen Alzheimer’s disease, marks a turning point in Biogen’s fortunes. The firm has seen falling revenues as competition challenges its lead products – Tecfidera (dimethyl…

June 8, 2021