Facilities & Capacity

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

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…

Novartis Building $55m gene therapy plant, Creating 200 Jobs in NC

A week after buying AveXis, Novartis has announced plans to build a gene therapy manufacturing facility in Durham, North Carolina. On May 15, Swiss Biopharma Novartis confirmed the completion of the US$8.7 billion (€7.4 billion) acquisition of clinical stage gene therapy firm AveXis. A week later, Novartis has unveiled plans for a $55 million gene therapy production plant in Durham, North Carolina to support AveXis’ gene therapy pipeline targeting rare neurological genetic diseases. AveXis’ lead candidate AVXS-101, in development for…

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

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…

Novasep Invests in Belgian Fill & Finish Site; Cites Lack of Global Capacity

The tension on the market surrounding the lack of fill & finish capabilities is ‘visible,’ says Novasep as it pumps US$12 million into a site in Belgium. The investment at Novasep’s site in Seneffe, Belgium will support the fill & finish for viral vectors, mAbs and other low-volume biologics. According to Laure Saloin, a spokesperson from the French life sciences services firm, the €10 million (US$11.8 million) spend supports the “one-stop-shop approach for our monoclonal antibodies and our viral-vectors bulk…

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…

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…

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…

PBL 3,000L Plant Could Alleviate Erwinaze Shortage

Porton Biopharma Limited (PBL) has opened a facility in Wiltshire, UK to make cancer drug Erwinaze (asparaginase Erwinia chrysanthemi). PBL is a biomanufacturer owned by the UK Government. Construction of the 2,100 m2 facility began in May 2016, through a multi-million pound investment from the UK’s Department of Health Capital funding. The plant has opened its doors and full production is set to commence over the next 12 months once the process of qualifying and validating the equipment is complete.…