Therapeutic Class

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…

Biogen Paying $650m to Up Stake in Samsung Bioepis

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…

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…

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…

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…

Samsung BioLogics: Rise of Biosimilars Behind Bioepis Accounting Change

Samsung BioLogics says it did not violate accounting rules. Change in its financial reporting related to plans by Biogen to up its stake in biosimilar JV, Samsung Bioepis. South Korea’s Financial Supervisory Service (FSS) released a preliminary statement last week accusing contract development and manufacturing organization (CDMO) Samsung BioLogics of accounting fraud. The special yearlong audit investigated a turnaround in Samsung BioLogics’ financials, when after years of losses it reported profits of KRW 1.9 trillion (US$1.8 billion) in 2015 ahead…

Lonza Building Hybrid Biomanufacturing Plant at NH Site

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…