Author Archives: Dan Stanton

Pfizer looks to freezer farms and thermal shippers to make COVID vaccine distribution ‘doable’

Pfizer says it is prepped to overcome the logistical challenges of distributing its mRNA vaccine against COVID-19 as it submits an Emergency Use Authorization (EUA) to the US FDA. Today, Pfizer submitted a request to the US Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of BNT162b2, an mRNA vaccine candidate codeveloped with Germany’s BioNTech, against SARS-CoV-2. The news follows Phase III trial data showing the vaccine has an efficacy rate of 95% and marks a major milestone…

Celltrion commits $453m for third plant with 60,000 L capacity

Celltrion is constructing a third manufacturing plant at its site in Songdo, Korea and has a fourth in the works as it aims to have 600,000 L of bioreactor capacity operational by 2030. Korean drugmaker Celltrion has four biosimilars on the market and a pipeline consisting of five other potential biosimilar products and two novel biotherapeutics. Currently the firm has 190,000 L of bioreactor capacity available to it across two biomanufacturing facilities at its site in Songdo, Incheon, but aims…

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…