Facilities & Capacity Archives - Page 65 of 73 - BioProcess InternationalBioProcess International

Novartis growing CAR-T network amid slow Kymriah sales

Novartis says it remains confident Kymriah will pull in $200 million in 2019 through the remediation and ramp-up of its CAR-T manufacturing network. For the third quarter 2018, Kymriah (tisagenlecleucel) netted Novartis $20 million (€17.4 million), making a total of $48 million for the first nine months of the year. The product became the first chimeric antigen receptor (CAR) T-cell to be approved in August 2017. Elizabeth Barrett, chief executive officer of oncology at Novartis, said the sales figures were…

Merck building second biologics plant at Irish site, adding 170 jobs

by Dan Stanton

The construction of a vaccine and biologics production at a site in County Carlow is the latest commitment to Ireland, says Merck & Co. Merck & Co. – known as MSD outside of North America – will construct a second plant at its site in Carlow, Ireland, about 80km south-west of Dublin. The project will create 170 new jobs. “The facility will focus on the production of vaccines and biologics and there will also be an expansion of warehouse and…

Eli Lilly to demolish mothballed Erbitux plant in NJ

by Dan Stanton

The former Imclone facility will be knocked down to give Eli Lilly “flexibility for future opportunities” at its Branchburg, New Jersey site, the firm says. Building 36 on Eli Lilly’s Branchburg, New Jersey campus is scheduled to be demolished by the end of the first quarter of 2019, Lilly spokesperson Tamara Ann Hull told BioProcess Insider. “A second building on the same campus – a new, higher capacity, modern facility, Building 50 – has been producing biologics since 2006. Therefore,…

Symbiosis: US FDA boost at Scottish aseptic viral vector plant

by Dan Stanton

Symbiosis has received US FDA approval for viral vector manufacturing fill/finish at its biomanufacturing facility in Stirling, UK. In this Q&A, CEO Colin MacKay explains the significance of the accreditation with regards to industry demand and Brexit. Scottish contract development and manufacturing organization (CDMO) Symbiosis Pharmaceutical Services constructed its sterile manufacturing facility in 2011 and has had UK regulatory accreditation since 2012. The firm recently received approval from the US Food and Drug Administration (FDA), something CEO Colin MacKay told…

Novartis’ Kymriah partner doubling capacity on global viral vector demand

by Dan Stanton

Oxford BioMedica – the sole manufacturer of the lentiviral vector for CAR-T Kymriah – will up capacity with a fourth facility to support future platform and pipeline deals. Oxford BioMedica, has signed a fifteen year lease on a new facility at its site in Oxford, UK-based, which when operational will more than double the firm’s bioprocessing capacity. The 7,800m2 facility – the fourth plant at the site – will contain four GMP clean room suites and two fill and finish…

Genmab on CMO use: ‘Keep brains inhouse, hands outside’

by Dan Stanton

Genmab says it chooses to outsource all its biomanufacturing having previously had its fingers burnt buying a facility in Minnesota, now owned by Takeda. In early 2013, Danish drugmaker Genmab A/S sold its non-plasma-derived antibody manufacturing facility in Brooklyn Park, Minnesota, to Baxter Healthcare Corporation for $10 million (€8.7 million). The 215,000 square-foot plant housed 22,000 L of mammalian cell culture bioreactor capacity, and was originally acquired by Genmab from PDL BioPharma in 2008 at a cost of $240 million.…

In-house investments let Synthon keep control of ADC production

by BPI Staff

Synthon Biopharmaceuticals chose to develop its antibody-drug conjugate (ADC) capabilities in-house to keep control of planning and product quality. Aad Van de Leur, COO of Synthon Biopharmaceuticals, spoke at KNect365’s Bioproduction Congress in Dublin, Ireland this week on the need to adapt biomanufacturing strategies and technologies for next generation therapies, using his own firm’s antibody-drug conjugate (ADC) capabilities as an example. “With the introduction of innovative high-potent biopharmaceuticals like antibody-drug conjugates (ADCs) the industry had to adapt and move to…

Yescarta: Gilead boasts 60 CAR-T clinics and counting

by Dan Stanton

There are now 60 different centers certified to administer CAR-T therapy Yescarta says Gilead Sciences says, which plans to add more as further indications are approved. In October 2017, the US Food and Drug Administration (FDA) approved the second chimeric antigen receptor T-cell therapy in the form of Yescarta (axicabtagene ciloleucel), developed by Kite which had recently been acquire by Gilead Sciences for $11.9 billion (€10.2 billion). Yescarta is made by isolating peripheral blood mononuclear cells – including T-cells –…

Bayer restructures factor VIII manufacturing, cuts 17% of jobs at Cali site

by Dan Stanton

Bayer will axe 227 jobs at its Berkeley, California site as it looks to restructure its recombinant factor VIII manufacturing network. The news comes weeks after its hemophilia treatment Jivi received US approval. Recombinant factor VIII protein (rFVIII) is used for the treatment of hemophilia A and employs genetically modified cells in its production. Bayer’s plant in Berkeley, California, is responsible for producing all three of its rFVIII therapies, including Jivi, a pegylated, long‐acting plasma/albumin free, full‐length rFVIII. The product…

GMP round-up: Samsung Bio becomes bigger, Rentschler fills aseptic gap

by BPI Staff

Korean CDMO Samsung BioLogics says its third facility is GMP ready and the largest single biomanufacturing plant in the world. Meanwhile, Rentschler has received GMP certification for an Austrian fill/finish plant. Samsung BioLogics has begun production at its third plant at its site in Incheon, South Korea. With 180,000 L of capacity from 12 times 15,000 L tank, the plant is the world’s largest single facility, according to the contract development and manufacturing organization (CDMO). It took Samsung BioLogics 10…