Author Archives: Dan Stanton

CMO deficiencies land Sanofi with CRL for sutimlimab

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Sanofi says it is working with its third-party manufacturer and the US FDA to resolve issues raised in the Complete Response Letter. French pharma giant Sanofi has suffered a setback after sutimlimab, its investigational monoclonal antibody for the treatment of hemolysis in adults with cold agglutinin disease, received a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA). The firm stated the letter refers to “certain deficiencies identified by the agency during a pre-license inspection of a…

November 17, 2020

Hyasynth harnesses biopharma processes bringing yeast-made CBD to market

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Using yeast fermentation in a similar way to insulin synthesis provides a cheaper, more sustainable way to make cannabinoids like CBD, says Hyasynth. Last month, Canadian firm Hyasynth received a $2.5 milllion milestone payment for its commercialization achievements in being first-to-market with cannabidiol (CBD) produced and extracted from a biomanufacturing setup. “It’s a typical yeast fermentation, so the equipment involved would be similar to the production of insulin,†Kevin Chen, CEO of Hyasynth told this publication. “We grow the yeast…

November 12, 2020

Flew vaccine? Merck teams to deliver meds by drone

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Merck & Co. has partnered with Volansi to test delivering cold chain products from a North Carolina manufacturing facility to a nearby health clinic. The ‘pilot’ scheme sees Merck (known as MSD outside of North America) use Volansi’s VOLY C10 drone to deliver vaccines and medicinal products from its facility in Wilson, North Carolina to Vidant Healthplex-Wilson, a Vidant Health clinic about two miles away. “This project is starting with Merck’s vaccines against measles, mumps, rubella, chickenpox, pneumonia, and hepatitis, 

November 9, 2020

eTheRNA expands its capabilities as mRNA interest grows

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Belgium’s eTheRNA has expanded its manufacturing capabilities to serve increasing demand for mRNA material driven by COVID-19 developments. The firm has added high throughout research grade messenger RNA (mRNA) services in addition to its GMP capabilities at facilities on the Antwerp University Science Park in Niel, Belgium. The decision to add a new 400 square-meter facility was driven by an increased demand for small scale research grade mRNA material, said Bernard Saegart, VP of Manufacturing at eTheRNA, who added expansion…

November 5, 2020

Bluebird: CMC and COVID delays push sickle cell gene therapy BLA back to 2022

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Bluebird bio has asked the US FDA to take a flexible and innovative approach to the CMC comparability data review for gene therapy candidate LentiGlobin. It had been estimated that bluebird bio was aiming to submit a Biologics License Application (BLA) for its gene therapy candidate LentiGlobin (autologous CD34+ cells encoding βA-T87Q-globin gene) in the second half of 2021. But following US Food and Drug Administration (FDA) concerns, guidance has been put back by a year, management said on a…

November 5, 2020

Novavax adds inhouse capacity to bolster COVID-19 and flu vaccines

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COVID-19 vaccine developer Novavax has secured two facilities in Maryland to support ongoing trials and scaled-up production. The first facility is a 122,000 square-foot plant in Gaithersburg, Maryland secured through a 15-year lease that will be built out and used for manufacturing, R&D, and offices from early 2021. It is located within a mile of Novavax’s headquarters. The second, also in Gaithersburg, is an 9.7-acre parcel of land acquired by Novavax for future development. The two sites will support Novavax’s…

November 3, 2020

COVID highlighting advantage of in-house CAR-T manufacturing, says Celyad

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With COVID-19 disrupting the supply chain, the advantages of inhouse manufacturing capabilities have never been so clear says CAR-T developer Celyad Oncology. In 2012, Celyad Oncology – then known as Cardio3 BioSciences – received GMP certification for its a facility in Mont-Saint-Guibert, Belgium to support its allogeneic and autologous chimeric antigen receptor (CAR) T candidates. Eight years on and in the midst of a pandemic, the decision to invest in internal manufacturing capabilities has never seemed so astute, says Celyad’s…

November 3, 2020

Sartorius to open Massachusetts customer interaction center

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The facility will serve as a focal point for Sartorius’ US customers to test and discover bioprocess solutions for their biopharma projects. To be known as the Customer Interaction Center (CIC), the facility in Marlborough, Massachusetts will serve as a center of excellence for Sartorius. “The new site will be a focal point for customers in what is now one of the world’s largest development hubs for biopharmaceutical products,†the firm said. The 40,000 square-foot facility aims to optimize factory…

October 30, 2020

Lonza to support AstraZeneca’s COVID-19 antibody combo

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Lonza will provide drug substance manufacturing for a potential COVID-19 monoclonal antibody combination therapy from its mid-scale facility in Portsmouth, New Hampshire. The deal, financials of which have not been disclosed, will see Swiss contract development and manufacturing organization (CDMO) Lonza make two monoclonal antibodies (mAbs) for AstraZeneca’s candidate AZD7442, currently in Phase I clinical studies as a potential treatment of COVID-19. The project will be one of the first from Lonza’s latest facility in Portsmouth, commissioned in 2018, with…

October 30, 2020

Novartis continues Kymriah capacity expansion with Japanese CDMO

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Novartis has tripled production capacity for its commercial CAR-T therapy Kymriah over the past year and continues to ramp up through a deal with Japan’s Foundation for Biomedical Research and Innovation (FBRI). Kobe, Japan-based FBRI has received marketing authorization from Japan’s Ministry of Health, Labor and Welfare (MHLW) to manufacture Kymriah (tisagenlecleucel) for Swiss pharma giant Novartis. The approval expands the manufacturing footprint of the chimeric antigen receptor (CAR) T-cell therapy, bringing Novartis its first Asian production facility. Furthermore, according…

October 30, 2020