Author Archives: Dan Stanton

MilliporeSigma and Thermo contribute to Biolife’s ‘blowout’ Q1

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Distributors STEMCELL Technologies and VWR also cited as sales of Biolife Solutions’s bio-preservation media and automated thawing products increased 51% year-on-year. For the first quarter 2019, Biolife, which makes and supplies biopreservation media and automated cell thawing media devices for cell and gene therapies, reported record revenues of $5.8 million (€5.2 million). “Dead cells don’t cure cancer, and the combined therapeutic, and economic risks our customers are facing should broaden use of our products as a best practice in the…

May 15, 2019

Pfizer opens $200m clinical manufacturing plant in MA

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The multiproduct facility will support early-phase manufacturing for its biologics pipeline, Pfizer says. Last week, pharma giant Pfizer cut the ribbon on the latest addition to its biomanufacturing network in Andover, Massachusetts. The Andover Clinical Manufacturing Facility (ACMF) represents an investment of $200 million (€178 million), which includes construction, additional processing equipment and qualification, according to Pfizer spokesperson Samantha Reardon. “The multi-product facility is designed to deliver early phase clinical supplies for Pfizer’s extensive biological portfolio,†she told Bioprocess Insider.…

May 15, 2019

Fungal infection? Biopharma embrace boosts Dyadic’s high titer platform

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Dyadic Internationally has struck three deals in two weeks as its industrially-proven fungus-based expression system receives the attention of biotech and Big Pharma. Dyadic reported a busy first quarter 2019 with R&D revenues of $403,000 (€359,000), more than double the same period 2018. The firm also updated investors on recent activity, specifically a wave of deals over the past few weeks supporting its C1 gene expression platform. In April, Australia’s Luina Bio struck a sub-licensing deal with Dyadic, and a…

May 15, 2019

Pfenex ready to play in next wave smaller biologics

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As industry looks to smaller sized proteins and engineered scaffolds, Pfenex believes its expression technology will make it a significant player in the space. For its first quarter 2019, Pfenex reported a 177% jump in revenues year-on-year to $10.4 million (€9.2 million), attributed to milestone payments and recognition of deferred revenues from its PF708 partners, and increased sales of its CRM197 product. Lead program PF708 is a recombinant protein form of parathyroid hormone with a PDUFA date of October 7.…

May 14, 2019

Subcutaneous success a boon for Halozyme, but biosimilars hit royalties

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Roche’s subcutaneous Herceptin (trastuzumab) recently became the third product to be approved using Halozyme Therapeutics’s ENHANZE drug delivery tech. However, Halozyme’s royalties have been hit by biosimilar competition. Halozyme Therapeutics reported what it described as a “strong start to 2019†with revenues of $57 million (€51 million) – up 84% year-on-year – attributed to $30 million upfront license fee from a license agreement struck with argenx in February. That deal gives argenx access to Halozyme’s ENHANZE drug delivery technology to…

May 10, 2019

Bayer plans $150m Californian biologics plant, creating 100 jobs

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Bayer has teamed with GE Healthcare and Fluor to build a single-use clinical manufacturing plant in Berkeley, California to support its biologics pipeline. Plans have been laid for a 40,000 square-foot ‘Cell Culture Technology Center’ on Bayer’s existing Berkeley campus in California, set to begin production in 2021. The site already makes products including Bayer’s recombinant Factor VIII treatment for hemophilia A. At a cost of $150 million (€134 million), the new plant will “enable clinical and launch production of…

May 10, 2019

Paragon buy and buildouts tipping Catalent’s business mix in favor of biologics

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The addition of Paragon Bioservices places biomanufacturing at around 31% of Catalent’s business mix. The CDMO expects it to be “north of 40%†by 2024 as high demand continues. Catalent reported revenues of $617.5 million (€552 million) for its third quarter FY2019 revenues, a slightly down on the same period last year. Traditionally a small molecule encapsulating contract development and manufacturing organization (CDMO), the firm’s Softgel Technologies segment dropped 6% year-on-year to $214.5 million. However, business was buoyed by its…

May 9, 2019

Merck injects $1bn into Virginia site to support HPV vaccines

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Merck & Co. will invest $1 billion over the next three years to increase production of its human papillomavirus (HPV) vaccine Gardasil at its Rockingham County site. Charlie McCurdy, a spokesperson for Merck & Co., confirmed to Bioprocess Insider his firm has committed to expand the Elkton facility in Rockingham County, Virginia facility to meet global demand for its HPV vaccines Gardasil and Gardasil 9. The $1 billion (€900 million) investment will be spread over the next three years to…

May 7, 2019

Alnylam: ‘Onpattro will springboard us into a global biopharma firm’

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Alnylam says it is on course to becoming “a global multiproduct commercial biopharma company†by 2020 as sales of its messenger RNA interference therapeutic Onpattro (patisiran) begin to ramp-up. Alnylam Pharmaceuticals made history in August 2018 when Onpattro (patisiran), its product for the polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis, became the first small interfering ribonucleic acid (siRNA) treatment to be approved by the US Food and Drug Administration (FDA). Reporting its first quarter 2019 financials, the firm described the milestone…

May 7, 2019

Buoyed by CGT growth, Bio-Techne plans plant to supply $200m of reagents

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Bio-Techne will invest $40 million to construct a GMP facility in Minneapolis expected to feed the growing demand for reagents in the cell and gene therapy space. The life sciences services and consumables firm reported a 12% growth in sales year-on-year in its third quarter FY2019 within its Protein Sciences segment. The segment – which supplies proteins such as cytokines and growth factors, immunoassays, antibodies and reagents to the biopharma industry – pulled in $138 million in the quarter. Its…

May 7, 2019