Mfg News: BioNTech, Ionis & GaldermaBy
A roundup of manufacturing news from BioNTech, Ionis Pharmaceuticals and Galderma. Highlights below.
* BioNTech To Establish mRNA R&D, Mfg Facility in Australia
* Ionis Plans New API Mfg Facility
* Galderma To Build Mfg Facility in Singapore
BioNTech To Establish mRNA R&D, Mfg Facility in Australia
BioNTech, a Mainz, Germany-based bio/pharmaceutical company, has agreed to a letter of intent with the local government of the State of Victoria in Australia to establish a mRNA research and innovation center and has announced plans for a clinical-scale manufacturing facility for mRNA-based products and candidates in Melbourne, Australia.
BioNTech is partnering with the State of Victoria in Australia on the mRNA research and innovation center as part of the government’s goal to build its ecosystem to support mRNA product by facilitating the transition of encouraging academic research into clinical development. BioNTech will curate projects and determine their potential transition into preclinical and clinical development.
BioNTech will also support local delivery by developing and commissioning an end-to-end clinical-scale manufacturing facility for mRNA-based medicines and product candidates in Melbourne, Victoria, Australia. The facility will use BioNTech’s BioNTainer, a mobile modular manufacturing unit.
BioNTech plans to further expand its clinical development capabilities in Australia and evaluate the testing of additional clinical cancer product candidates, including an autologous CAR-T cell therapy candidate, BNT211, in addition to two Phase II candidates currently being tested in Australia.
Ionis Plans New API Mfg Facility
Ionis Pharmaceuticals, a Carlsbad, California-based bio/pharmaceutical company focused on RNA therapies, has entered into an agreement with Sudberry Properties, a San Diego, California-based real estate development company, to develop and lease a new development chemistry and active pharmaceutical ingredient (API) manufacturing site in Oceanside, California.
Sudberry will develop and construct the shell for the approximately 217,000-square-foot building, and Ionis will fill the inside to customize the facility. Under the agreement, Ionis will lease the property for 20 years, with two 10-year options to renew and a right of first offer to purchase the property.
Ionis expects to occupy the new facility in 2025, with API manufacturing beginning in mid-2026. The facility will be more than double the size of Ionis’ existing development chemistry and manufacturing facility in Carlsbad.
Source: Ionis Pharmaceuticals
Galderma To Build Mfg Facility in Singapore
Galderma, a Zug, Switzerland-based company specializing in dermatology pharmaceuticals and dermatology cosmetics, has announced its intention to build a manufacturing plant in Singapore to increase its manufacturing capacity by up to 350 million units per year. The new facility will be the company’s fifth manufacturing plant.