Author Archives: Dan Stanton

Sartorius (cell) banks on mammalian manufacturing

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Sartorius Stedim Biotech says its newly launched mammalian cell bank manufacturing offering fits hand-in-hand with its existing cell line development services. German bioprocess vendor Sartorius has grown its contract testing and manufacturing services over the past few years, not least through the acquisition of analytics and product characterization firm BioOutsource in 2015. Now the subsidiary Sartorius Stedim BioOutsource will offer the manufacture of GMP master and working cell banks (MCB/WCB) for mammalian suspension cells from its site in Glasgow, UK.…

August 16, 2019

CMOs to continue picking up Big Pharma non-core facilities

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Recent facility acquisitions by Lonza and Catalent show Big Pharma is divesting its non-core assets in a trend that is set to continue, according to PharmSource. In the previous couple of months, contract manufacturing organizations (CMOs) Lonza and Catalent have both increased their production networks through facility acquisitions. Lonza’s expansion incorporates a sterile, multi-product drug product facility in Stein, Switzerland, acquired from fellow Swiss firm Novartis. Catalent, two weeks prior, added its first biologics plant outside the US through a…

August 14, 2019

Lonza to simplify vein-to-vein supply chain with Vineti partnership

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The cell and gene therapy industry is at a global inflection point says Lonza as it teams with logistics firm Vineti to remove the supply chain hurdles affecting the space. The non-exclusive partnership will see contract development and manufacturing organization (CDMO) Lonza incorporate Vineti’s real-time end-to-end supply chain platform into its cell and gene therapy offering. “The Vineti and Lonza partnership is a preferred business collaboration to drive manufacturing efficiencies in the C&GT [cell and gene therapy] manufacturing process by…

August 13, 2019

Momenta drops Humira biosimilar, pays GSK $43m in manufacturing hit

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Momenta says planned runs at manufacturing partner GSK could be reattributed to another product as it ends development of M923, a biosimilar candidate to Humira (adalimumab). In October 2018, Momenta Pharmaceuticals said it was exiting the biosimilars space following a lengthy strategic review process to concentrate on its novel biologics pipeline. The company told Scrip it would terminate all but two late-stage programs, a biosimilar version of AbbVie’ blockbuster Humira (adalimumab) and a biosimilar of Regeneron’s Eylea (aflibercept). Ten months…

August 12, 2019

Bio-Techne: $50m reagent plant will support cell & gene therapies

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Plans for a $50 million GMP reagent facility in Minnesota are materializing at Bio-Techne as it looks to support the burgeoning cell & gene therapy sector. In its third quarter FY2019 financial call, life sciences services and consumables firm Bio-Techne spoke of intentions to build a $40 million (€36 million) GMP facility in Minneapolis, Minnesota to produce reagent proteins for use in cell and gene therapy applications. Three months on, the firm has said plans are now laid to invest…

August 12, 2019

FDA and NIIMBL partner to advanced biomanufacturing innovation

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The US FDA has expanded its partnership with NIIMBL to strengthen biomanufacturing through innovations such as 3D printing and continuous manufacturing. The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) launched in March 2017 to accelerate innovation in biopharmaceutical manufacturing and support the development of standards to drive more efficient and rapid manufacturing capabilities. Institute Director, Kelvin Lee told Bioprocess Insider the institute is already working with the US Food and Drug Administration (FDA) in a variety of contexts –…

August 9, 2019

Pro-biosimilar policies will not ignite US market, Amgen

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Amgen says the US needs a vibrant competitive biologics market but must avoid policies that tilt the playing field in favor of biosimilar makers. Biosimilars made an initial mark in the US when the Food and Drug Administration (FDA) approved Sandoz’s Zarxio (filgrastim) in 2015. But in the proceeding four years, the sector has somewhat stalled – despite 22 more approvals – amid ongoing political debate, legal complexities and pricing/reimbursement. The idea of Congress addressing drug pricing and patent issues,…

August 9, 2019

GE and Millipore drive ‘exceptional’ quarter for Repligen’s Protein A

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Sales in its proteins business grew over 40% year-on-year as Repligen experienced higher than expected demand for Protein A ligands from customers MilliporeSigma and GE Healthcare. Bioprocessing vendor and protein supplier Repligen Corporation reported another record quarter with sales of $71 million (€63 million), up 48% year-on-year. The firm has spent the past few years diversifying its portfolio – and areas of investment in filtration and chromatography, for example, helped drive the quarter – but strong results came from its…

August 9, 2019

FDA and Novartis back Zolgensma amid data manipulation issues

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The US FDA remains confident that Zolgensma will not be pulled after being alerted to allegations of data manipulation by the gene therapy manufacturer AveXis. In May 2019, Novartis company AveXis received US Food and Drug Administration (FDA) approval for its $2.1 million single-dose, one-time gene therapy Zolgensma (onasemnogene abeparvovec) to treat children less than two years of age with spinal muscular atrophy (SMA). A month later, AveXis informed the Agency “about a data manipulation issue that impacts the accuracy…

August 7, 2019

Novo Nordisk to convert Purdue NC plant to make oral diabetes drug

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Novo Nordisk will rebuild a facility in Treyburn, North Carolina acquired from Purdue Pharma to support an oral form of its GLP-1 analogue semaglutide. In an email sent to staff and posted on cafepharma.com, Craig Landau – CEO of OxyContin maker Purdue Pharma – said an evaluation of his firm’s manufacturing operations and capabilities has resulted in the sale of its Treyburn solid oral dose plant to Danish drugmaker Novo Nordisk. Financial details of the deal have not been divulged,…

August 5, 2019