Thermo Fisher Expands Plasmid DNA Mfg, Supply-Chain Ops
The latest from CDMOs, CMOs, and suppliers featuring Thermo Fisher Scientific, Fujifilm Diosynth Biotechnologies, Vectura, and Matica Biotechnology.
Biologics Manufacturing
Thermo Fisher Expands Clinical, Commercial Plasmid DNA Mfg
Thermo Fisher Scientific has announced plans to construct a new cGMP plasmid DNA manufacturing facility in Carlsbad, California.
The site will expand the company’s clinical and commercial capabilities for plasmid DNA, which is used as a raw material to develop and manufacture cell and gene-based therapies. In addition, the site will have the capability to produce large-scale plasmid DNA as a primary drug substance for DNA therapies.
The 67,000-square-foot facility is expected to be completed in the first half of 2021.The facility will include single-use equipment up to 1,000-L scale and add approximately 150 jobs over the next 12 months (as reported on December 16, 2020).
This expansion builds on the company’s continued investment in cell and gene therapy facilities, including: (1) viral vector facilities in Cambridge, Lexington and Plainville, Massachusetts, and Alachua, Florida; (2) a new cell-therapy manufacturing facility in Princeton, New Jersey; and, (3) a new dedicated cryocenter in Weil am Rhein, Germany to provide specialized cryogenic and cold-chain supply chain services to support clinical trials across Europe and globally.
Source: Thermo Fisher Scientific
Fujifilm Diosynth To Add Process Characterization Labs in the UK
Fujifilm Diosynth Biotechnologies, a biologics CDMO, plans to double its existing process characterization capacity through the addition of dedicated laboratories at its site in the UK.The expansion is scheduled to be completed by the late fall 2021.
Source: Fujifilm Diosynth Biotechnologies
CHA Biotech Expands Viral Vector Mfg with New CDMO, Facility
Matica Biotechnology, a recently launched CDMO of CHA Biotech, a South Korea-based biopharmaceutical company, has signed a lease agreement to construct a viral vector production facility in College Station, Texas.
Construction of the 25,000-square-foot facility will begin in the fourth quarter of 2020 and will be dedicated to the production of viral vectors used in cell and gene therapies, vaccines, and oncolytic products. It is scheduled to open in the third quarter of 2021.
In June (June 2020), CHA Biotech announced its goals to raise KRW 75 billion ($68 million) to launch its CDMO business.
Source: Matica Biotechnology (facility) and Matica Biotechnology (CHA investment)
Formulation Development/Drug Product Manufacturing
Vectura Expands To Include HPAPI Inhalation Capabilities
Vectura, a Chippenham, UK-based CDMO of inhalation drug products, has announced an expansion of its capabilities to handle and develop highly potent active pharmaceutical ingredients at its facility in Chippenham, UK.
The project will include the installation of six new containment isolators for housing development manufacturing equipment for dispensing, blending, co-milling, jet-milling, spray-drying and blister-filling into a newly modelled product development manufacturing laboratory.
The new facility will increase the containment capabilities at the site and allow Vectura scientists to handle APIs with an occupational exposure limit as low as 0.1 µg/m3. The isolators will allow flexible set-up of equipment to widen the nature of inhaled drug development projects. Installation, and validation of all equipment is projected to be completed early in 2021.
Source: Vectura
Packaging
Thermo Fisher Adds Two New Clinical Supply-Chain Facilities in Germany
Thermo Fisher Scientific has expanded its clinical supply-chain continuity and specialized cold-chain and cryogenic services with the addition of two new facilities in Rheinfelden and Weil am Rhein, Germany. The Rheinfelden site opens in late December 2020 and the Weil am Rhein site will open in January 2021.
In Rheinfelden, the new 86,000-square-foot facility increases the company’s footprint for secondary packaging, storage, logistics and distribution of clinical supplies to investigator sites across Europe. In Weil am Rhein, the new 9,600-square-foot cryocenter provides specialized ultra-low-temperature, cryogenic storage and cold-chain expertise for clinical supply-chain needs for cell and gene-based therapies, including COVID-19 vaccine candidates.
The new Rheinfelden and Weil am Rhein facilities are located in proximity to the company’s existing clinical services sites in Basel, Switzerland, and Horsham, UK, as well as to its dedicated cell and gene therapy facilities in Bishop’s Stortford and Stevenage, UK.
Source: Thermo Fisher Scientific
