Global Markets

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…

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.…

Catalent’s Next 5 Years: Biomanufacturing Demand to Outstrip Supply

Catalent says it is evaluating separating out its biologics business after investments and M&A have propelled the CDMO out of the sub-5,000 L space. Catalent has reported revenues of US$628 million (€524 million) for its third quarter fiscal 2018. The contract development and manufacturing organization (CDMO) attributed 18% year-on-year jump to “robust organic growth†in its biologics business and the acquisition of Cook Pharmica last October. The $950m deal added an 875,000ft2 production and fill/finish site in Bloomington, Indiana, complementing…

Complex Sandostatin Manufacturing Holding Off Competition, Novartis

The complexity to manufacture the growth hormone inhibiting peptide Sandostatin will ensure protection from competition, says Novartis. 2017 sales of the acromegaly peptide Sandostatin (octreotide) were down slightly on the previous year, but still brought in US$1.6 billion (€1.3 billion) for Swiss biopharma Novartis. During the firm’s recent first quarter financial call, board member Elizabeth Doherty told stakeholders that while the firm is always looking at potential risks from competition, “we know ourselves with our own experience how difficult it…

AbbVie Braces for 20% Erosion as EU Humira Biosimilars Assemble

AbbVie expects impact from Humira (adalimumab) biosimilars in Europe beginning the fourth quarter but remains confident there will be no direct US competition until 2022. AbbVie is preparing for Humira biosimilar entrants beginning in the fourth quarter 2018, the firm said during a first quarter conference call. A settled lawsuit with Samsung Bioepis earlier in the quarter laid the way for the Korean firm’s adalimumab biosimilar Imraldi to be launched as soon as October 16 by commercialization partner Biogen. Meanwhile,…

Another Biosimilar CRL for Pfizer, but Manufacturing not the Cause

Pfizer has received a US FDA complete response letter (CRL) for its proposed version of Roche’s breast cancer monoclonal antibody Herceptin (trastuzumab). Pfizer announced its biologics license application (BLA) for PF-05280014 has been turned down by the US Food and Drug Administration (FDA), with the agency highlighting the need for additional technical information in the CRL. The requested information does not relate to safety or clinical data, Pfizer said in a release. The news comes less than a year after…