Facilities & Capacity

Grist for the MIL: CDMO Cognate making cell therapies for WindMIL

WindMIL Therapeutics has upped a contract with Cognate BioServices to make its marrow-infiltrating lymphocyte (MIL) cell therapies but says it is developing plans to eventually build in-house manufacturing capabilities. WindMIL, a cancer immunotherapy firm developing autologous cell therapies based on its marrow-infiltrating lymphocytes (MILs), initially began working with contract development and manufacturing organization (CDMO) Cognate last year. Now the firm has expanded the contract to add extra clinical manufacturing capacity. “We are securing one additional manufacturing suite at Cognate’s Memphis,…

Autolus hires MolMed to add vector flexibility

Autolus Therapeutics says hiring MolMed as a contractor for its CAR-T programs was about adding flexibility. The biotech announced contracted MolMed to develop and manufacture vectors for its candidate CAR-T cancer therapy programs this week. Under the deal MolMed will make viral vectors to support Autolus’ various clinical trial programs. An Autolus spokeswoman told us “MolMed is a future supplier. “The MolMed relationship is Autolus taking the normal and prudent step to build flexibility and parallel supply for vector.” The…

Fujifilm breaks ground on $14.5m UK biocampus

Fujifilm Diosynth Biotechnologies says the site in Billingham will support biologic, vaccine and gene therapy development and manufacturing for its customers. Work began on the site in Billingham in the North of England this week, 10 months after the contract development and manufacturing organization (CDMO) first announced plans for the biocampus to support its pharma clients in the development and manufacture of biologics, vaccines and gene therapies. The expansion, set to represent an investment of up to $14.5 million (€13…

Emergent to make Novavax’s Covid-19 vaccine candidate for Ph I trials

Emergent says Covid-19 vaccine candidate it is making for Novavax will be ready for trials within four months. Novavax hired Emergent BioSolutions to make the experimental vaccine this week. The vaccine was developed using Novavax’s recombinant protein nanoparticle platform and Matrix-M adjuvant technology. Emergent said it has already started work on making clinical trial supplies of the vaccine, explaining that drug substance will be produced at the Baltimore-Bayview facility while the product itself will be made at its Baltimore-Camden plant.…

Samsung Bio lands MAb development contract with STCube

Samsung Biologics has landed another development project when STCube asked it to help it with a cancer monoclonal antibody candidate. The South Korean contract development and manufacturing organization (CDMO) will provide cell line and process development services. It will also manufacture material for preclinical development and human trials. The monoclonal antibody in question targets an unspecified protein – called STT-003 by STCube – that is found on the surfaces of cancer cells. According to STCube, because cancer cells express high…

Fujifilm kicks off gene therapy expansion in Texas

CDMO Fujifilm Diosynth Biotechnologies has begun constructing a $35 million expansion at its College Station, Texas site, intended to feed the demand for gene therapy services. Having announced the expansion in November, contract development and manufacturing organization (CDMO) Fujifilm Diosynth Biotechnologies has begun adding cell culture and high throughput manufacturing suites at its College Station, Texas plant, to support the growing demand for of gene therapy production. The investment represents $35 million of the JPY 13 billion ($120 million) injection…

Iovance on balancing $85m inhouse plant with CDMO WuXi

Iovance will use CDMO WuXi Apptec for initial commercial supply of lifileucel, but a Philadelphia plant under-construction looks to bring its tumor infiltrating lymphocyte (TIL) cell therapies inhouse. Iovance announced in June last year that it is constructing a 136,000 square-foot facility in Philadelphia, Pennsylvania to manufacture its pipeline of autologous cell therapy candidates. At the time, the plant was expected to cost Iovance $75 million (€69 million) over three years “for equipment and construction of the manufacturing suites,” but…

AveXis ‘flexible’ NC plant a step closer to fully internal gene therapy network

AveXis has opened a gene therapy plant in Durham it says will be able to produce up to seven products simultaneously. President Dave Lennon talks timelines, capacity, and taking production inhouse. AveXis and its owner Novartis have invested a total of $115 million (€106 million) into a site in Durham, North Carolina to support the production of US Food and Drug Administration (FDA) approved product Zolgensma (onasemnogene abeparvovec) and its pipeline of gene therapy candidates. With the doors opening last…

Another WuXi Vaccines deal? No, just a repurposed press release

Contrary to some reports, WuXi Biologics is not building a second facility for its recently formed vaccines joint venture but has merely secured the $3 billion contract announced last May. Nine months ago, WuXi Biologics and Shanghai-based Hile Bio-Technology formed WuXi Vaccines, a contract development and manufacturing organization (CDMO) to service a Letter of Intent (LOI) inked with an undisclosed multinational vaccine company. In November, plans were laid to build a $240 million (€222 million) three-story dedicated manufacturing facility in…

Audentes $109m NC expansion boon for Astellas gene therapy plans

Astellas acquisition Audentes has laid plans to build a 135,000 square-foot gene therapy manufacturing plant in Sanford, North Carolina. The $109 million (€100 million) plant is expected to be operational in 2021 and will support Audentes’ gene therapy portfolio. The firm’s lead product is AT132, a Phase I/II clinical-stage experimental treatment for X-linked myotubular myopathy (XLMTM), though the firm is also developing gene therapies for Pompe disease and Duchenne Muscular Dystrophy (DMD). “Our investment in large-scale manufacturing has always been…