Facilities & Capacity Archives - Page 72 of 73 - BioProcess InternationalBioProcess International

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

by Dan Stanton

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’

by Dan Stanton

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

by BPI Staff

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.…

Lonza Building Hybrid Biomanufacturing Plant at NH Site

by Dan Stanton

Lonza plans to bolster its mid-scale biomanufacturing and cell therapy capabilities at its site in Portsmouth, New Hampshire on the back of growing demand. The expansion will include mid-scale mammalian capacity through the installation of several 6,000 L bioreactors which will eventually replace stainless steel 5,000 L systems operating at the site. “This will be a hybrid facility combining stainless steel for the main reactor with single use technologies for some of the upstream and downstream processing,” Sylke Hassel, SVP…

Teva: Migraine Mab Delay After ‘Negative Surprise’ of Celltrion Warning

by Dan Stanton

Manufacturing issues are likely to delay the approval of fremanezumab but Teva remains confident its migraine drug will launch this year. Teva Pharmaceutical Industries’ monoclonal antibody (mAb) candidate fremanezumab is under regulatory review as a preventive treatment for chronic migraine. The US Food and Drug Administration (FDA) has assigned fremanezumab a Prescription Drug User Fee Act (PDUFA) action date mid-June, but the firm announced yesterday it expects a delay on the decision due to manufacturing issues. “There’s not much doubt about…

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

by Dan Stanton

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…

WuXi Biologics Takes ‘First Giant Step’ Out of China with 54,000 L plant

by Dan Stanton

WuXi Biologics will invest €325 million (US$390 million) in its first production site outside of China. The Irish site will be fully disposable, the CDMO told BioProcess Insider. The contract development and manufacturing organization (CDMO) is looking to construct a single-use site with 54,000 L of disposable bioreactor capacity through a €325 million investment in Mullagharlin, County Louth, Ireland. When GMP ready in 2021, the site will be equipped with twelve 4,000-L fed-batch bioreactors and six 1,000-L bioreactors for…

Complex Sandostatin Manufacturing Holding Off Competition, Novartis

by Dan Stanton

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…

Out with the Old, In with the New Tech as J&J Eyes CAR-T Investment

by Dan Stanton

Johnson & Johnson says it needs to invest in tech and capacity in areas like CAR-T as it looks to restructure its supply chain restructure. J&J announced the supply chain restructure as part of its first quarter 2018 financials, telling investors the action would refocus resources towards “critical capabilities, technologies and solutions necessary to manufacture and supply its product portfolio of the future.” The restructure will free between $600 and $800 million (€501 and €668 million) annually by 2022, though…