Facilities & Capacity

Mustang expands ‘bubble boy’ gene therapy footprint with European CDMO

Mustang Bio has established a European manufacturing base for its lentiviral gene therapy candidate MB-107 through a deal with cell and gene therapy CDMO Minaris. Developed with St. Jude Children’s Research Hospital, MB-107 is Mustang Bio’s lentiviral gene therapy for the treatment of X-linked severe combined immunodeficiency (XSCID), also known as bubble boy disease. The candidate, which received US FDA Orphan Drug Designation in September, is manufactured from a facility in Worcester, Massachusetts but the firm is now looking outside…

Pharming doubling downstream capacity for commercial HAE therapy

Pharming Group will build a facility at its site in Oss, the Netherlands to increase downstream manufacturing capacity for Ruconest, a recombinant human C1 esterase inhibitor approved for the treatment of angioedema attacks in patients with hereditary angioedema (HAE). Dutch pharma firm Pharming is building a new facility to expand downstream processing capacity at its site in Pivot Park, Oss. Once operational, the facility will carry out the purification, filtration and concentration of the starting material for lead product Ruconest…

Samsung Bio in $150m deal to make COVID antibodies for Lilly

Korean CDMO Samsung Biologics will produce COVID-19 antibody therapies for Eli Lilly as it signs another multi-hundred-million-dollar contract with a Big Pharma firm. Eli Lilly originally approached contract development and manufacturing organization (CDMO) Samsung Biologics in May as it looked to secure capacity for its range of potential COVID-19 treatments. Samsung was able to manufacture and deliver an initial supply of Active Pharmaceutical Ingredients (API) within five months, and as such the CDMO has become a strategic partner for Eli…

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…