Author Archives: Dan Stanton

Orgenesis talks cell therapy development for diabetes

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Orgenesis has received Orphan Drug Designation for a potential autologous insulin producing cell therapy to treat severe hypoglycemia-prone diabetes resulting from total pancreatectomy. With the designation, Orgenesis hopes to expedite its Autologous Insulin Producing (AIP) cells as a cell replacement therapy for the treatment of severe hypoglycemia-prone diabetes resulting from total pancreatectomy due to chronic pancreatitis. “The therapy is based on taking a small amount of liver cells from the patient. These are propagated to the desired amount of cells…

June 21, 2019

Lonza building capacity for Gamida’s bone marrow transplant

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Lonza will construct suites at its site in The Netherlands dedicated to producing Phase III and commercial supply of Gamida’s bone marrow transplant cell therapy omidubicel. Lonza has produced clinical supply of omidubicel for Gamida but the strategic deal announced today will see the Swiss contract development and manufacturing organization (CDMO) fulfil the future commercial supply from its site in Geleen, The Netherlands. Formerly known as NiCord, omidubicel is the Massachusetts-based cell therapy firm’s lead candidate, currently in Phase III…

June 19, 2019

Celgene pays BeiGene $150m as it hands back anti-PD-1 rights

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Ahead of its acquisition by Bristol-Myers Squibb, Celgene has agreed to hand back the development and commercialization rights of solid tumor candidate tislelizumab to Chinese drugmaker BeiGene. In August 2017, BeiGene inked a deal to acquire Celgene’s commercial operations and portfolio assets in China while handing over the exclusive rights to develop and commercialize its investigational anti-PD1 antibody, BGB-A317 (tislelizumab) for solid tumors outside of the region. But in a report filed with the SEC yesterday, BeiGene said the two…

June 19, 2019

Alpine inks iPSCs vision lost therapy deal with Allele

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In collaboration with Alpine BioTherapeutics Corporation, Allele Biotechnology and Pharmaceuticals will make therapies for retinal diseases based on induced pluripotent stem cells (iPSCs) The deal, financials of which have not been divulged, sees the two firms enter into a research agreement for developing iPSC-derived cell therapy for treating diseases including blindness caused by Retinitis Pigmentosa, Stargardt disease, and dry AMD. Alpine, which has a patented stem cell differentiation technique used to generate human retinal stem cells from pluripotent stem cells,…

June 18, 2019

The scale-X factor: Univercells wins $14m grant to make low-cost measles vaccines

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Univercells aims to make affordable measles and rubella vaccines using its NevoLine biomanufacturing platform incorporating the scale-X fixed-bed bioreactor. In a consortium with Batavia Biosciences and Natrix Separations, Belgium-based Univercells has been able to develop a manufacturing platform that has slashed the cost of production of inactivated polio vaccine (sIPV). Now, through a $14.3 million (€12.8 million) from the Bill & Melinda Gates Foundation, the firm is looking to adapt the platform to produce low-cost measles and rubella (M&R) vaccines…

June 18, 2019

MilliporeSigma plans to ramp up filtration manufacture in NH

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MilliporeSigma intends to add an additional 38,500 square feet of manufacturing space at its site in New Hampshire to support demand for filtration devices. The bioprocessing business unit of Germany’s Merck KGaA, MilliporeSigma, has revealed it is planning to expand a site in Jaffrey, New Hampshire that makes filtration equipment for the life sciences industry. “To meet the future demands of the bioprocessing market, we are in the approval process to expand the facility with additional cleanroom and lab space…

June 17, 2019

Amgen: ‘We’ve shaved 3 years off development but can do better’

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Amgen says it hopes to rapidly develop new medicines from a collaboration with Intermountain Health as its EVP of R&D discusses changing timelines. Wholly-owned Amgen subsidiary deCODE genetics will have access to the genomes of 500,000 Utah-based participants from a study carried out by not-for-profit healthcare provider Intermountain Healthcare. Amgen hopes to use this data to uncover new insights into specific diseases and develop new medicines that reach the right disease targets. Speaking at the Goldman Sachs 40th Annual Global…

June 17, 2019

Middle class: Lonza on the flexibility of midscale biomanufacturing

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With construction of a 6,000 L scale hybrid plant underway, CDMO Lonza says there is high demand among its customers for midscale biomanufacturing. In this industry, companies and commentators like talking about extremes: either small-scale single-use or large-scale stainless steel. But speaking at the BPI Theater at BIO in Philadelphia earlier this month, Stéphane Varray, commercial development for midscale at Lonza Pharma and Biotech said midscale options provide firms with flexibility across numerous modalities. “When we look at midscale we’re…

June 14, 2019

Fujifilm tackles buffer bottleneck at $10m continuous processing plant

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Fujifilm Diosynth Biotechnologies says it can overcome the burden of large buffer volumes associated with continuous purification as part of a new UK processing facility. The facility in Billingham, UK will include a 500 L single-use perfusion bioreactor and 7 downstream processing units and is expected to begin offering process development later this year. The plant represents a $10 million (€8.9 million) investment by the contract development and manufacturing organization (CDMO) and is the culmination of three years of in-house…

June 14, 2019

America has 20 approved biosimilars but you’ll never believe how many have launched!

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With the FDA approving Amgen And Allergan’s version of Roche’s Herceptin (trastuzumab) America’s biosimilar tally has reached 20… But only seven have reached the market. Clickbait headline aside, this week marks another major milestone in the US biosimilar market: the approval of its twentieth biosimilar Kanjinti (trastuzumab-anns), a version of Roche’s cancer monoclonal antibody Herceptin developed by Amgen and Allergan. The approval is the third in Amgen’s portfolio and the second of four biosimilars from an Amgen and Allergan collaboration…

June 14, 2019