Author Archives: Dan Stanton

Photo opp: How imaging companies focused on cell and gene therapies

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Fujifilm and Nikon say their respective moves into regenerative medicine came from a rich heritage in imaging services such as X-rays and microscopes. In January 2018, Fujifilm Corporation, through its contract development and manufacturing organization (CDMO) business Fujifilm Diosynth Biotechnologies (FDB), opened an 80,000 square-foot facility in Texas for the production of clinical and commercial gene therapies. Months later it announced plans to expand the site, adding gene therapy fill/finish capabilities. Investments in such an innovative field as gene therapies…

February 18, 2019

Drones to bioreactors: CDMO Culture Biosciences ready to fly high

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Culture Biosciences has secured $5.5 million in funding. Founded by former Google X engineers, the CDMO has harnessed drone delivery technology to support its bioreactor simulation and scale-up services. Led by Section 32, with participation from Refactor Capital and Verily, South San Francisco, California-based firm Culture Biosciences has raised $5.5 million (€4.9 million). The contract development and manufacturing organization (CDMO) is offering biotech firms a digital biomanufacturing platform and bioreactor facilities to run, monitor and analyze bioreactor experiments to assess…

February 15, 2019

AstraZeneca ups yields but takes $400m hit on plant closures

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“We can produce the volume we need with more limited manufacturing capacity,†says AstraZeneca in the wake of closing two biologics facilities in Colorado. Last month, AstraZeneca announced plans to consolidate its US biologics manufacturing operations. This included closing facilities in Boulder and Longmont, Colorado less than four years after acquiring them from Amgen, and moving operations to its site in Frederick, Maryland. The restructure aims to drive efficiencies in its operations network, but the Anglo-Swedish firm said it expects…

February 15, 2019

Manufacturing Insights: Interviews from BWB 2018 Highlight Perspectives on Streamlining Manufacturing Timelines

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Addressing manufacturing and technologies strategies to accelerate market entry is one of BPI’s highlighted themes for 2019. In partnership with our conference colleagues in Informa’s KNect365 division, this already has been a shared theme, reflecting the general goals of the industry and related advice from its regulators. BPI’s summer 2018 preconference ebook included interviews by Dan Stanton (editor, BioProcess Insider) with speakers previewing their talks for the BPI Conference in Boston on 7 September 2018. Two of those conversations focused…

February 14, 2019

January-February BioProcess Insider

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Launched in June 2018, the BioProcess Insider digital information portal delivers the latest financial and business news and expert insider views influencing the commercialization of biopharmaceuticals. Here are just a few recent stories edited for our space limitations in print. For more discussion and in-depth analysis, check out the website at www.bioprocessinsider.com and sign up for the twice-weekly newsletter. AstraZeneca Closing Two Colorado Sites Anglo-Swedish pharmaceutical giant AstraZeneca is ending operations at its facilities in Boulder and Longmont, CO, less…

February 14, 2019

Charles River CRO to continue to expand biomanufacturing support biz

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Following a strong year for its manufacturing services division, Charles River Laboratories intends to invest further to benefit from the high growth in biologics. Contract Research Organization (CRO) Charles River reported full year 2018 revenues of $430 million (€381 million) within its manufacturing support division, up 11.9% on the previous year. The unit provides manufacturing services for drug developers, including cell line characterization, lot release testing and stability studies. Increasingly, the business has focused on biologics, reflecting industry’s shifting pipelines,…

February 14, 2019

Big Pharma and CAR-T: Testing the water or in at the deep end?

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Following Novartis and Gilead’s success, others are “scrambling to build up their T-Cell capabilities,†say venture capitalists. We look at where Big Pharma stands in this blossoming sector. Big Pharma firms will be looking at strategies to enter the chimeric antigen receptor (CAR) T-cell space, if they have not already, spurred on by the approvals in 2017 of Kymriah (tisagenlecleucel) and Yescarta (axicabtagene ciloleucel) . This was the view of commentators and analysts at Phacilitate in Miami, Florida last month. Anna…

February 13, 2019

Dual sourcing drives global network as WuXi inks Amicus deal

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WuXi Biologics will harness its growing global network to supply the commercial drug substance and product for Amicus Therapeutics’ Pompe biologic ATB200. Amicus Therapeutics is developing a therapy consisting of recombinant human acid alpha-glucosidase (rhGAA) enzyme with an optimized carbohydrate structure, administered with a small molecule pharmacological chaperone. The product, ATB200, will be made by contract development and manufacturing organization (CDMO) WuXi Biologics. The firm, which has been working with Amicus to scale-up the product over the past few years,…

February 13, 2019

Samsung Bioepis inks biosimilar deals to enter China

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Samsung Bioepis has teamed with C-Bridge Capital to bring its third-wave biosimilars to the Chinese market. C-Bridge will establish a new company, AffaMed Therapeutics, under terms of the deal, and will license multiple biosimilar candidates from Samsung Bioepis to commercialize in China. These include the third-wave biosimilar candidates SB11 and SB12 – versions of Roche/Novartis’ Lucentis (ranibizumab) and Alexion’s Soliris (eculizumab) – and SB3, a biosimilar of Roche’s Herceptin (trastuzumab). The deal comes weeks after a partnership deal with 3SBio…

February 12, 2019

Cell therapy firms and vendors look to automation technologies

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Nearly 90% of cell therapy firms plan to invest further into automation technologies within five years, a KNect365 survey finds. KNect365’s Life Sciences Cell Therapy Automation Survey 2018 collated the responses of 158 life science executives and engineers. When asked to what extent companies are currently automating their process, the results ranged from 14% not using automation at all to 7% claiming all their processes are automated. This averages out to around 52% of processes being automated. Process automation (for…

February 8, 2019