Author Archives: Dan Stanton

Coherus Resubmits Neulasta Biosimilar, Aims for November Approval

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…

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

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…

Gilead to Open European Plant to Support CAR-T Manufacture

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…

Collaboration Aims to Address Large DNA Plasmid Scale-Up Issues

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…

Valerius Picks Catalent to Make ‘Specialty Biosimilar’ Pipeline

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…

First US Epogen Biosimilar Approved as Pfizer Fixes GMP Issues in Kansas

The FDA upgraded Pfizer’s troubled McPherson, Kansas facility in January paving the way for the approval of Retacrit – a biosimilar version of Amgen’s Epogen (epoetin alfa). The US Food and Drug Administration (FDA) approved Retacrit as the first biosimilar version of Amgen’s anemia drug Epogen yesterday. “The FDA’s decision to approve Retacrit for all indications of the reference product marks a critical and positive step forward in helping create a marketplace for biosimilars in the US, further advancing opportunities…

Lilly Buys Back Early Phase Oncology Kinase in $110m AurKa Deal

Eli Lilly adds AK-01 – an Aurora kinase A inhibitor it originally discovered – to its early-stage pipeline. The acquisition comes days after Lilly bought Armo BioSciences for US$1.6 billion. In 2016, biopharma giant Eli Lilly sold AK-01 to venture capital firm TVM Capital Life Science, which went on to establish AurKa Pharma. This week, the firm has announced it is buying it back through the acquisition of AurKa. The is an Aurora kinase A inhibitor being tested in multiple…

Rise of the Insects: Thermo Fisher Hails Non-Mammalian Expression for Vaccines

Encouraged by success of Flublok and Cervarix, Thermo Fisher says insect protein expression systems are one of the most promising technologies being used in the development of next-generation vaccines. Thermo Fisher has launched the Gibco ExpiSf system, an insect protein expression system aimed at generating baculovirus using a suspension-based transfection protocol it says delivers protein in half the time compared to traditional insect platforms. BioProcess Insider spoke with Amy Butler (AB), vice president and general manager, Cell Biology at Thermo…

Takeda: ‘$62bn Shire Megamerger Brings Greater Geography and Scale’

After weeks of negotiations, Shire has agreed to a Takeda takeover bid worth US$62 billion. The combined company will consist of over 35 manufacturing sites globally. Japanese firm Takeda first made a bid for Ireland-headquartered rare diseases biopharmaceutical company Shire in March. After several rebuffed offers, the firms agreed to merge this week in a deal worth $62 billion (€52 billion). The deal is subject to shareholder and regulatory approvals. A $32 billion bid for Shire made by AbbVie in…

Repligen Reports Record Revenue, Continues on M&A Hunt

Repligen will launch several new filtration and chromatography offerings this year as its strategy of developing products based on technology acquisitions pays off. For the first quarter 2018, Repligen Corporation reported record revenues of US$45 million (€38 million), up 46% on the same period last year. The bioprocessing company attributed the results to strong sales of its filtration and chromatography products – up by over 90% year-on-year – bolstered by the $359 million acquisition of Spectrum in June 2017. “Our…