Facilities & Capacity

Iovance plant on track for 2022 and lifileucel BLA set for next year

Iovance Biotherapeutics says its new cell therapy plant in Philadelphia is on track to begin commercial production in 2022. The firm updated on development of the facility at the Navy Yard complex in Philadelphia during its Q3 earnings call, telling analysts clean rooms are due to be operational for clinical trial supply production in 2021. Iovance announced plans for the $125 million Philadelphia facility in May last year, explaining it would be used to make autologous TIL products including lifileucel…

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…

Vibalogics launches US expansion with $150m virotherapy plant

CDMO Vibalogics plans for its late-phase clinical and commercial manufacturing facility to be operational in 2021. Vibalogics, a contract development and manufacturing organization (CDMO) specializing in oncolytic viruses, viral vector vaccines and viral vector gene therapy products, has entered the ‘Phase I’ stage of the investment into the site. The three-year project will see a 110,000-square-foot facility constructed near Boston, Massachusetts, which will be operational in the second half of 2021. This investment follows on from the German company’s expansion…

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…

TCR2 makes first steps into US with ElevateBio manufacturing deal

TCR2 Therapeutics has established manufacturing capacity in the US, as it looks to Phase II trials for its solid tumor candidate TC-210. ElevateBio will provide manufacturing and technical expertise for TC-210, a cell therapy that is currently in Phase I/II trials and being prepared to enter Phase II. The production will take place at ElevateBio’s BaseCamp, a 140,000-square-foot cell and gene therapy manufacturing facility based in Waltham, US. ElevateBio secured the funding for the site and its operations last year,…

CDMO Minaris invests $64.5m to triple capacity in Europe

The cell and gene therapy CDMO will build additional facilities at its German and Japanese locations. The contract development and manufacturing organization (CDMO) specializing in cell and gene therapies announced two separate investments of $40.7 million (€34.2 million) into its Ottobrunn, Germany, site, and $23.8 million for its Yokohama, Japan, site. Both regions now come under the umbrella of Minaris Regenerative Medicine, a subsidiary of Showa Denko Materials, after a rebrand in September to unify the name of its three…

Pfizer building clinical trial supply plant as part of €300m Ireland expansion

Pfizer will build a plant in Ringaskiddy, Cork to support its clinical trials as part of a €300 ($355) million investment in Ireland. The US drug giant announced it would expand capacity in Ireland this week, explaining the investment included the initial stage of a project to construct the clinical trial supply facility at its existing Ringaskiddy site. A spokesman told us “This type of activity is highly specialized manufacturing working with our global research and development group. The initial…

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…

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…