Author Archives: Dan Stanton

Fujifilm Adds Automated Filler for Late-Stage Gene Therapies at Texas Plant

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Recent gene therapy approvals have driven the demand for third-party services, says Fujifilm as it expands fill & finish capabilities at its recently opened site. In January 2018, Fujifilm Diosynth Biotechnologies opened an 80,000 sq-ft facility in College Station, Texas, for the manufacture of gene therapies. This week, the contract development and manufacturing organization (CDMO) has expanded the plant to support the fill & finish of Phase III and commercial products by adding a Vanrx Pharmasystems’ SA25 automated filler. “We…

May 25, 2018

eBook: The Future of Monoclonal Antibody Manufacturing — Incremental Improvement or Industrial Revolution?

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Monoclonal antibody manufacturing is at a crossroads. Biomanufacturers could continue exploring new technologies and fine-tuning proven systems such as mammalian cell expression systems in stirred-tank bioreactor fed-batch cultures. But some experts say an opportunity is arising to turn the industry on its head by taking lessons from other branches of bioprocessing, such as the industrial enzyme sector. Drug makers are criticized often these days for the high prices of their products. The lay media, governments, payers, and patients themselves all…

May 24, 2018

Gilead Flies a Kite for ZFN Gene Editing Tech Over CRISPR

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Gilead’s CSO spoke about its choice of zinc finger nuclease (ZFN) for ex-vivo gene editing at the Bank of America Merrill Lynch Healthcare Conference. In February, Kite Pharma – acquired by Gilead Sciences for US$11.9 billion in last August – struck a deal to use Sangamo Therapeutic’s ZFN technology to modify genes in the development of its autologous and allogeneic cell therapies. Kite/Gilead paid $150 million up front to the fellow Californian firm but Sangamo could be entitled to a…

May 24, 2018

WuXi Biologics: Zero to 220,000L of Capacity in 10 Years

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WuXi Biologics has invested US$60 million to build a biomanufacturing facility in Singapore. By 2022, the CDMO will have 10 plants – an achievement it attributes to disposable and modular technologies. WuXi Biologics has announced plans to add a S$80 million (US$60 million) clinical and commercial biologics manufacturing in Singapore to its growing global network. When operational, the site will boast 4,500 L biomanufacturing capacity comprised of two 2,000 L traditional fed-batch and one 500 L perfusion based continuous processing…

May 23, 2018

Biogen Paying $650m to Up Stake in Samsung Bioepis

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Biogen has opted to increase its control in biosimilar venture Samsung Bioepis to 49.5%, according to partner Samsung BioLogics. Biogen sent South Korean biomanufacturer Samsung BioLogics a letter last week declaring its intention to increase its stake in the firms’ joint venture Samsung Bioepis from 5.4% to 49.5%. According to Samsung BioLogics, Biogen will pay around 700 billion Won (US$650 million) for an additional 44.6% stake in the JV, with the deal expected to take two to three months to…

May 22, 2018

Coherus Resubmits Neulasta Biosimilar, Aims for November Approval

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With successful preapproval inspections at its manufacturing sites, Coherus BioSciences is confident its CHS-1701 pegfilgrastim biosimilar will be approved by the end of the year. In 2017, California-based Coherus received a US Food and Drug Administration (FDA) complete response letter (CRL) for its version of Amgen’s Neulasta (pegfilgrastim), CHS-1701. The CRL requested a reanalysis of a subset of subject samples with a revised immunogenicity assay, along with additional manufacturing related process information. Earlier this month, Coherus announced it resubmitted its…

May 18, 2018

Multi-Media Player: GE Invests in EU and US Plants to Tap $1.4bn Market

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The increased demand for cell growth media from biomanufacturers has driven capacity expansions at sites in Utah and Austria, says GE Healthcare. Globally, GE Healthcare has cell culture media production in Tuas (Singapore), Pasching (Austria), and Logan (Utah, US). To support growing demand from the biopharma industry, the life sciences firm has announced capacity expansions at the two latter plants. “Cell culture media is the fastest growing segment within the cell culture market and it was valued at US$1.4 billion in…

May 18, 2018

Gilead to Open European Plant to Support CAR-T Manufacture

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The site near Amsterdam, The Netherlands will be Gilead Sciences/Kite’s third manufacturing facility to support production of its cell therapies. “The site in Hoofddorp will be Kite’s manufacturing base in Europe, enabling Kite to efficiently manufacture and deliver its cell therapies to people living with cancer in Europe,†Gilead spokesperson Sarah Swift told BioProcess Insider. When operational in 2020, the 117,000 ft2 site will provide 300 new jobs. Gilead Sciences entered the cell therapy space last August through the US$11.9…

May 18, 2018

Collaboration Aims to Address Large DNA Plasmid Scale-Up Issues

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CDMO Biomay has teamed with BIA Separations to tackle bottlenecks in the cell lysis and purification stages of large DNA plasmid production. Chromatographic column maker BIA Separations will work with Biomay to develop a high yield and purity manufacturing process for ‘large’ plasmid DNA used for therapeutic application. Large plasmids are commonly used as starting materials for manufacturing of viral gene therapy vectors, said Hans Huber, COO of Biomay. “For instance, manufacturing of the adeno-associated viral vector system (AAV) requires three…

May 17, 2018

Valerius Picks Catalent to Make ‘Specialty Biosimilar’ Pipeline

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High productivities and specialized targets means Catalent’s 2,000 L scale bioreactors can easily realize production needs for its orphan biosimilar and biobetter candidates, says Valerius Biopharma’s CEO. Swiss biopharma firm Valerius Biopharma has selected Catalent Biologics to provide cell line development and cGMP manufacturing for its burgeoning biosimilar pipeline. The firm has not disclosed the specific targets but CEO Andreas Herrmann told BioProcess Insider “two are biosimilars of orphan drugs and the other two are products, where we want to…

May 16, 2018