Author Archives: Dan Stanton

Regeneron teams up and takes $100m stake in bluebird bio

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Regeneron has increased its interest in cellular therapies through a T cell co-development partnership with bluebird bio. The deal sees Regeneron Pharmaceuticals and bluebird bio combine their respective tech platforms to discover, develop and commercialize an initial six candidates against tumor-specific proteins and peptides, including chimeric antigen receptor (CAR) T and other T cell receptors (TCRs). As part of the collaboration, Regeneron has invested $100 million (€87 million) in its new partner bluebird, buying 420,000 shares at a price of…

August 6, 2018

Esco Aster to transfer CAR-T tech to Chinese biomanufacturing plant

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The Singapore-based CDMO will fit out Wuhan Bio-Raid Biotechnology’s facility in China with its lentiviral vector platform and bioproduction technologies. Esco Aster has signed a memorandum of understanding (MoU) to use its lentiviral vector platform and bioproduction technologies to support Wuhan Bio-Raid’s chimeric antigen receptor (CAR) T-cell therapy pipeline in China. “Under the MoU, both parties have achieved a broad understanding to increase the speed of CAR-T development in China,†Esco Aster spokesperson Ai San Yip told BioProcess Insider. This…

August 6, 2018

BioTime spinning out regenerative med firm AgeX

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BioTime has received US$43 million (€37 million) from Juvenescence for a stake in AgeX and plans to spin the cell therapy subsidiary out in September. In April 2017, Californian late-stage biotech BioTime formed the subsidiary AgeX therapeutics to focus on its human aging candidates derived from regenerative stem cells. Earlier this year, fellow aging-focused firm Juvenescence made a $5 million investment in the subsidiary, and this week has upped its stake by 14.4 million shares paying BioTime $21.6 million in…

August 3, 2018

Amgen Breaks Ground on $160m Rhode Island Plant

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Amgen has broken ground on a single-use and modular biomanufacturing facility at a site in Rhode Island. The groundbreaking ceremony at the West Greenwich site took place today in the presence of the governor of Rhode Island, Gina Raimondo and congressman Jim Langevin. Construction of the plant will begin in September. The facility, first announced in April, will make biologics for the US and global market once operational. It has been described as a “next-generation biomanufacturing plant,†meaning it is…

July 31, 2018

Q2 Results: Bioprocessing Vendors Return to Double-Digit Growth

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Thermo Fisher and Sartorius are among bioprocessing vendors reporting a return to double-digit year-on-year growth, following ‘lumpy’ results in the same quarter 2017. For the second quarter 2018, Thermo Fisher reported revenues from its Life Sciences Solution segment of US$1.6 billion (€1.4 billion), up 12% on the same period last year. Fellow vendor Sartorius reported Q2 sales in its Bioprocessing Solutions unit up 14% in constant currency over last year, pulling in €287 million ($336 million), while order uptake was…

July 31, 2018

Lonza: CAR-T Manufacturing Glitch an Industry Problem, not Just Novartis’s

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Novartis has reported issues around the manufacture of Kymriah (tisagenlecleucel). With CAR-T being a new field, teething problems are normal, says CDMO Lonza. In August 2017, Novartis became the first company to receive US Food and Drug Administration (FDA) approval for a chimeric antigen receptor (CAR) T-cell therapy. But during its Q2 results, the Swiss Biopharma admitted some issues in the manufacturing of the therapy for its diffuse large B-cell lymphoma (DLBCL) indication. “We have seen some variability in our…

July 30, 2018

Bioproduction: A ‘Tale of Two Facilities,’ Says Jacobs

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The advent of single-use bioreactors has revolutionized facility design says Jacobs, which has worked in the biomanufacturing sector for almost 30 years. As the biotech industry matured in the 1990s, Jacobs Engineering acquired Triad Technologies and Sigel Group to expand its expertise in designing and constructing biotechnology facilities. The firm has since been involved in many of the most prominent biomanufacturing facilities over the past few decades, working on Schering-Plough’s (now Merck & Co.) facility in Tuas, Singapore; Bristol-Myers Squibb’s…

July 30, 2018

Sangamo Bets on CAR-Treg Through $84m TxCell Acquisition

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CAR-Treg is the next biology of interest for gene-modified cellular therapies says TxCell, which is set to be acquired by Sangamo Therapeutics. Sangamo Therapeutics has agreed to buy French biotech TxCell for approximately €72 million (US$84 million), bolstering its pipeline with cellular immunotherapies based on regulatory T lymphocytes, or Tregs. The acquisition will help bring candidates, including TX200 for transplant rejection, through the clinic and towards commercialization, TxCell’s CEO Stephane Boissel told Bioprocess Insider. “We did not want to start…

July 27, 2018

FDA Greasing the Wheel for Biosimilar Adoption Through Action Plan

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The US FDA has published an action plan to promote and expedite biosimilar competition. Healthcare consultant Steven Lucio tells us “we are at a critical point in time in the biosimilar development landscape.†Last week, the US Food and Drug Administration (FDA) published a ‘Biosimilars Action Plan’ aimed at promoting access to lower-cost biosimilar drugs while maintaining a desire for new biologics innovation. “By enabling a path for competition from biosimilars, we also give innovators an added incentive to invest…

July 25, 2018

Neupogen Biosimilar Success: Pfizer Banks on Discounts and Patient Confidence

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The US Food and Drug Administration (FDA) has approved Pfizer’s Nivestym; a second biosimilar of Amgen’s Neupogen (filgrastim). In March 2015, the FDA approved its first biosimilar: a version of Neupogen called Zarxio, marketed by Novartis subsidiary Sandoz. Three years later and a second filgrastim biosimilar is close to being available after the FDA approved Pfizer’s product NIvestym. A spokesperson from the Biopharma firm told BioProcess Insider Pfizer will be able to compete against both Amgen’s reference biologic and Sandoz’s…

July 24, 2018