Author Archives: Dan Stanton

Aglaris talks automated and closed cell therapy platform

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Anglo-Spanish firm Aglaris has developed an autonomous, closed production system for the manufacture of cell therapies such as T-cells and MSCs (Mesenchymal Stem Cells). According to new CEO Steven Docksey, the platform overcomes many issues associated with this new product class. “Most current processes are intensive, manual techniques derived and scaled-up from the cell preparation techniques used in research labs – adapting existing tools to the job. There is little in the way of genuine innovation that has come to…

October 18, 2018

Eli Lilly to demolish mothballed Erbitux plant in NJ

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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,…

October 17, 2018

Symbiosis: US FDA boost at Scottish aseptic viral vector plant

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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…

October 17, 2018

Novartis’ Kymriah partner doubling capacity on global viral vector demand

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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…

October 16, 2018

BioProcess Insider for October

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Launched in June 2018, the BioProcess Insider digital information portal delivers the latest financial and business news and expert insider views influencing the commercialization of biopharmaceuticals. Here are just a few recent stories edited for our space limitations in print. For more discussion and in-depth analysis, check out the website at www.bioprocessinsider.com. Every edition provides expert and insider perspectives on current financial movements and deal-making; the newest technology purchases and capacity investments; regulations affecting the bioprocessing sector; global market actions…

October 15, 2018

Merck drops Lantus biosimilar, blames pricing and production cost concerns

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Merck & Co. has ended the commercialization of Lusduna, a version of Sanofi’s Lantus (insulin glargine), and will pay Samsung Bioepis a termination fee of around $155 million. In 2014, Merck & Co. (known as MSD outside of North America) entered into an agreement with Korean biosimilar maker Samsung Bioepis to commercialize an insulin glargine candidate for the treatment of patients with type 1 and type 2 diabetes. The product, Lusduna, formerly MK-1293, was approved in Europe in January 2017…

October 15, 2018

BMS invests in Compugen, grants access to Opdivo for combo trial

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Compugen has gained access to top-selling programmed death-1 (PD-1) inhibitor Opdivo (nivolumab) through collaboration and a $12 million investment from Bristol-Myers Squibb. Israeli early-phase biotech Compugen’s candidate COM701, a first-in-class therapeutic antibody targeting PVRIG, will be investigated in combination with Bristol-Myers Squibb’s monoclonal antibody (MAb) Opdivo (nivolumab) after signing a clinical partnership with the big pharma firm. “We discovered PVRIG as immune checkpoint proteins using our computational target discovery platform. We prioritized this target among the marketable other internal programs…

October 15, 2018

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

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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.…

October 12, 2018

Biosimilar round-up: Deal-breaking, approvals, and patents

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Mundipharma acquires Cinfa; Sandoz resolves dispute with AbbVie; FDA favours Celltrion and Teva’s rituximab. Welcome to the heady world of biosimilars. First up is an acquisition in the biosimilars space, with Cambridge, UK-based Mundipharma bolstering its portfolio through the purchase of Spanish drugmaker Cinfa Biotech. Financial have not been divulged, but Mundipharma gains immediate access to Pelmeg, a biosimilar which is looking to take a slice of the global $4.5 billion pegfilgrastim market. Pelmeg received recommendation for approval on September…

October 12, 2018

Turning over a new Leaf? Plant-based expression as a disruptor

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Plant-based protein expression offers high yields and easy harvesting but has been held back by a lack of funding and the ubiquity of mammalian and bacterial systems, says Leaf Expression Systems. UK-based contract biopharmaceutical development firm Leaf Expression Systems has appointed Simon Saxby, a former executive at contract manufacturing organizations (CMOs) Recipharm and Cobra, as its CEO. Leaf Expression Systems offers the production of proteins, antibodies and vaccines through its Hypertrans expression system, based on tobacco plants. Saxby’s immediate focus…

October 10, 2018