BioNTech says the manufacture of messenger RNA (mRNA) is simple and quick to adapt when dealing with COVID-19 variants threatening the efficiency of approved vaccines. Just 15 months ago, BioNTech was a relatively unknown player in the biopharma industry. With a global pandemic, partnership with Pfizer, and a historically fast vaccine development, approval and roll-out under its belt, the German mRNA firm is now a household name. In December 2020, the firm’s BNT162b2 became the first mRNA vaccine to be …
Author Archives: Dan Stanton
Sanofi to build $700m Canadian flu vaccine plant
Sanofi says the facility in Toronto, Canada will provide antigen and filling capacity for its high-dose quadrivalent influenza vaccine Fluzone. Sanofi’s high-dose (HD) quadrivalent flu vaccine Fluzone is the latest variant of the French biopharma long-standing Fluzone franchise, approved by the US Food and Drug Administration (FDA) in people aged 65 and older in November, replacing the HD trivalent product. The vaccine is currently manufactured exclusively by Sanofi Pasteur, Sanofi’s vaccines global business unit, at its Swiftwater, Pennsylvania site but…
Podcast: Thermo Fisher on aseptic manufacturing in the time of COVID
In the latest episode of the BioProcess Insider Expression Platform, Thermo Fisher Scientific’s Vincenza Pironti discusses how vaccine and biologic makers can ensure a robust, global fill/finish supply both during the COVID pandemic and beyond. Vincenza Pironti – Global SME, Steriles, ThermoFisher Scientific – sat down (at a distance) with editor Dan Stanton to discuss aseptic manufacturing in the current climate as part of this year’s BIO-Europe Spring. The event took place last week, but if you missed it the…
Turning a corner in CAR-T: FDA approves ide-cel
The US FDA has approved Abecma (ide-cel); the first CAR-T for a non-CD19 target and the second cell therapy in eight weeks for Bristol-Myers Squibb. This weekend, the US Food and Drug Administration (FDA) approved Abecma (idecabtagene vicleucel, commonly referred to as ide-cel) as the first cell-based gene therapy for the treatment of multiple myeloma. Developed by Bristol-Myers Squibb acquisition Celgene and fellow advanced therapy maker bluebird bio, Abecma is a B-cell maturation antigen (BCMA)-directed genetically modified autologous chimeric antigen…
Novartis exiting Longmont due to changing gene therapy capacity need
Novartis will close its Longmont, Colorado biomanufacturing after over anticipating the amount of capacity needed to produce Zolgensma and other gene therapies. When Novartis acquired AveXis in May 2018, it quickly began expanding its manufacturing network to support the then lead candidate Zolgensma (onasemnogene abeparvovec-xioi1). By the time the gene therapy won US approval as a treatment for spinal muscular atrophy (SMA) in May the following year, Novartis was confident it had built up a sufficient production footprint for launch…
Boehringer Ingelheim boosted CDMO biz through €370m spend in 2020
Boehringer Ingelheim invested in capacity at sites in Germany and Austria last year on the back of high capacity utilization and increased demand for CDMO services. While most of Boehringer Ingelheim’s revenues come from its own portfolio of human and animal therapeutics, Boehringer Ingelheim’s biopharma contract manufacturing business pulled in €837 million ($986 million) in 2020, up 6.6% on the year prior. According to the firm’s annual report, “Boehringer Ingelheim covers the entire biopharmaceutical value chain, from development of the…
Curi Bio receives $6m funding boost for human stem cell platforms
The financing will support Curi Bio’s 2D and 3D platforms, which aim to improve the predictivity of human stem cell-derived tissue for drug discovery. Curi Bio’s platform technologies use human iPSC-derived cells, tissue-specific biosystems, and AI-enabled data analytics to help accelerate the discovery of therapeutics. The Series A financing round, led by Dynamk Capital, will help grow the business and validate the tech to show the need for predictive and mature human stem cell platforms to close the gap between…
Spain’s mAbxience boosting biologics capacity with 4,000 L SUB
Biosimilar maker and CDMO mAbxience will install an ABEC 4,000 L CSR bioreactor at its site in León, Spain. mAbxience, the biologics division of Spain’s Insud Pharma group, claims its León plant is “the biggest biologic plant in Spain and the first in Europe with fully integrated single-use technology in most processes.†Now the site is set to get bigger, with a 4,000 L single-use bioreactor (SUB) system expected to be installed in the coming months, which, according to the…
WuXi Bio set for 430,000 L biomanufacturing capacity from 2024
The acquisition of CMAB Biopharma comes days after WuXi Biologics bought a Pfizer facility, months after it added a Bayer plant, and a decade after it entered the biomanufacturing space. Contract development and manufacturing organization (CDMO) is in the news again, just a week after it acquired a single-use biologics manufacturing plant in Hangzhou, China from Big Pharma firm Pfizer. This time it has entered an agreement to buy over 90% of fellow Chinese CDMO CMAB Biopharma for an undisclosed…
Fujifilm selects NC for 160,000 L mammalian plant
Infrastructure, state incentives, and proximity to an existing facility have driven CDMO Fujifilm Diosynth Biotechnologies to select Holly Springs, North Carolina as the site of its Â¥200 billion biologics plant. In January, Fujifilm Corporation announced plans to invest Â¥200 billion (then $2 billion, now $1.8 billion) to build a biologics facility in the US run by its contract development and manufacturing organization (CDMO) business Fujifilm Diosynth Biotechnologies (FDB). Details, including the planned mammalian cell culture capacity of 160,000 L (made…