Author Archives: Dan Stanton

Lonza making 400m doses of COVID vaccine and can scale up further if Moderna asks

With four manufacturing lines prepped to produce 400 million doses, Lonza has congratulated Moderna on positive interim results for its mRNA vaccine against COVID-19. Biopharma has appeared to gain the upper hand on its battle against COVID-19 in the past week. First Pfizer and BioNTech reported positive interim results – a 90% efficacy rate – in a Phase III study of its mRNA vaccine candidate, and days later Moderna topped this reporting that its mRNA vaccine was shown to be…

Seqirus injects $580m into Australian cell-based flu vaccine plant

The site in Melbourne will be the first cell-based manufacturing facility in the southern hemisphere to produce flu vaccines, along with Seqirus’ adjuvant MF59 and Australian antivenoms. Seqirus has been making seasonal flu jabs since 2015 after parent company CSL Limited acquired Novartis’ global influenza vaccine business. The firm has increasingly moved away from egg-based vaccine production towards cell-based manufacturing and has scaled up its capacity to meet demand. The latest investment announced this week is a plan to spend…

CMO deficiencies land Sanofi with CRL for sutimlimab

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…

Hyasynth harnesses biopharma processes bringing yeast-made CBD to market

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…

Flew vaccine? Merck teams to deliver meds by drone

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,”…

eTheRNA expands its capabilities as mRNA interest grows

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…

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

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…

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

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…

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

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…

Sartorius to open Massachusetts customer interaction center

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…