Author Archives: Gareth Macdonald

Sarepta plans gene editing center; files DMD therapy for review

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Genetic disease-focused firms need infrastructure says Sarepta, which shared plans for a gene editing center of excellence at the JP Morgan healthcare conference. The gene editing center will be in Durham, North Carolina according to CEO Douglas Ingram, who said investing in capacity and knowhow is key to Sarepta’s longevity. “If one is going to be an enduring genetic medicine company, we are going to need infrastructure,†he said, citing partnerships as an important part of the expansion. “We’re deepening…

January 17, 2020

Horizon says base editing tech could make cell therapies safer

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Horizon Discovery Group says a new DNA editing tech could move multi-gene knockout cell therapies through trials with improved safety profiles. The technology in question – called the Pin Point system – is an editing platform that allows developers to precisely modify DNA at the base-level. The approach differs from CRISPR/Cas9 and other conventional editing techniques that create cuts in genes, which could result in unintended changes and lead to deleterious effects in patients Horizon says. The firm will offer…

January 15, 2020

Yposkesi to make Genethon and Sarepta’s DMD gene therapy

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Genethon and Sarepta have contracted Yposkesi to make AAV material for a Duchenne muscular dystrophy (DMD) gene therapy they are developing. The therapy in question is called GNT0004. It consists of an AAV-type viral vector and a shortened version of the dystrophin gene (microdystrophin). According to preclinical data published in the journal Nature the therapy is able to produce significant restoration of muscle function with stabilization of clinical symptoms. Under the new manufacturing deal Yposkesi will produce clinical and large-scale…

January 13, 2020

UMass Lowell opens pilot freeze-drying development lab

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UMass Lowell has opened a lyophilization testing facility where researchers and biopharma can develop freeze-drying processes in a non GMP environment. The facility – dubbed LyoBay – is located in the Mark and Elisia Saab Emerging Technologies and Innovation Center at UMass Lowell, which is located northwest of Boston. It is intended as a development space for scientists and biopharmaceutical companies according to executive director, Karen Hamlin. “The LyoBay offers users the opportunity to take their product technology from the…

January 13, 2020

iBio aims to cut manufacturing costs and improve data management with AI

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iBio will use blockchain tech to cut costs and improve traceability in a deal that may also see Mateon spin-out a biopharma AI specialist. Plant-based biologics CDMO iBio asked EdgePoint AI – a unit of Mateon Therapeutics – to install artificial intelligence (AI) technologies at its manufacturing facility in Bryan, Texas. The idea is that the systems – known as TrustPoint Vision Fabric and TrustPoint Smart Protocols – will monitor production operations conducted and store data in a “blockchain.†Cost savings…

January 8, 2020

Getinge pays $89m for Applikon to boost life sciences biz

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Getinge has bought Applikon Biotechnology to expand its life sciences technologies business. Sweden’s Getinge announced it would pay SEK 840 million ($89 million) for Applikon last month. It said the Dutch bioreactor firm’s technology portfolio would bolster its biopharma segment. It cited Applikon’s range of systems for the research and production of vaccines and antibodies as well as those for the production of enzymes and bio-plastics as the main motivation. “Applikon Biotechnology has a strong portfolio of world class bioreactor solutions…

January 7, 2020

How process optimization brought Bivigam back to the market

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ADMA Biologics says a data driven approach was key to bringing its primary immune deficiency disease drug Bivigam back to market. Bivigam (Immune Globulin Intravenous [Human], 10% Liquid) relaunched in the US in August, roughly three years after it was pulled from pharmacy shelves by then owner, Biotest Pharmaceuticals Corporation. Biotest withdrew Bivigam in late 2016 after a US FDA inspection team uncovered “multiple manufacturing inconsistencies and control issues†at its facility in Boca Raton, Florida. ADMA bought Biotest in…

January 3, 2020

Lonza teams with 3D bioprinting firm Allevi

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Lonza has partnered with 3D bioprinting materials firm Allevi citing growing biopharma demand for bespoke organs for drug discovery research. The collaboration – terms of which were not disclosed – will see the Swiss contract development and manufacturing organization (CDMO) combine its primary cells and culture media with Philidelphia-based Allevi’s range of bioprinter and bioink production technologies. The idea is to cater for biopharma developers looking to manufacture organs and tissues for drug discovery. Lonza said it collaborates with selected…

January 2, 2020

Korean CDMOs set for Government-backed biopharma boom

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South Korean CDMOs are poised for significant growth after the Government said contractors are key to its efforts to encourage drug R&D and manufacturing in the country. In May South Korean President Jae-in Moon announced this summer that the country will invest more than KRW 2 trillion ($1.7B) in the biotechnology and biopharmaceutical industry. Moon said, “We will do our best to create an ecology of innovation tailored to all stages of growth from technological development and approval and licensing…

January 1, 2020

Dendreon extends lease on Atlanta Provenge plant

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Dendreon has extended the lease for the facility in Union City near Atlanta where it makes its prostate cancer cell therapy, Provenge (sipuleucel-T). The Chinese-owned cell therapy firm first leased the 155,000 square-foot facility in 2009, shortly before Provenge was approved by the US Food and Drug Administration (FDA). The extension covers use of the Union City site through to 2029. Christina Yi, chief operations officer at Dendreon said, “Over the past 10 years, we have grown locally, building key…

January 1, 2020