New cGMP plasmid DNA manufacturing facility
Thermo Fisher Scientific is developing a new current good manufacturing practice (cGMP) facility in Carlsbad, California to expand its clinical and commercial capabilities for the production of plasmid DNA for cell and gene-based therapies.
The new facility is scheduled for completion in the first half of 2021. It will add approximately 150 jobs over the next 12 months.
The 67,000ft2 plasmid DNA manufacturing facility will be located on the Carlsbad campus of Thermo Fisher, the centre of excellence for life science solutions to capitalise on the company’s long-standing presence in the city and leverage its rich talent pool.
The new state-of-the-art production facility will incorporate advanced technologies, including single-use equipment with a scale of up to 1,000l, digital connectivity, and data visibility to facilitate operational efficiencies and operator training.
CGMP plasmid DNA is used as a critical raw material for the manufacturing of life-saving cancer treatments as well as mRNA vaccines. The cGMP site will be strategically equipped to offer comprehensive end-to-end cell and gene therapy capabilities and will accelerate the commercialisation of plasmid-based medicines and vaccines.
The site would also be capable of developing large-scale plasmid DNA as the primary drug material for DNA therapy.
An expansion will complement the viral vector services that the company offers from its facilities in Cambridge, Lexington, Plainville, Massachusetts, and Alachua, Florida, as well as from its cell therapy manufacturing plant in Princeton, New Jersey, and a new cryocentre in Weil am Rhein, Germany.
In biotechnology, plasmids have several uses and are regularly utilised as cloning vectors in bacteria and for the production of large-scale proteins, gene therapy, mRNA therapy, vaccine development, genetic modification, and animal-disease models.
Plasmids have played a key role over the last three decades as a commonly used molecular tool in various microorganisms and animal cells for DNA alteration and gene expression.
The key step in the workflow includes robust purification of plasmid DNA, in the volume and purity needed for the downstream application of interest.
A wide variety of Thermo Scientific™ GeneJET™ and Invitrogen™ PureLink™ plasmid purification kits have been designed and developed with the customer’s experimental specifications, plasmid purity, and throughput criteria in mind.
Thermo Scientific GeneJET Plasmid Mini Kit uses silica-based membrane technology in the shape of a convenient spin column. The kit recovers up to 20μg of high-copy plasmid DNA by isolation procedure.
Invitrogen PureLink Fast Low-Endotoxin plasmid purification kits utilise next-generation columns with advanced silica membranes to allow rapid, precipitation-free isolation of transfection-grade (<1 EU/μg) plasmid DNA.
The simple precipitation-free protocol generates high-quality plasmids and is ideal for standard transfections as well as all molecular biology applications such as cloning and sequencing.
Headquartered in Boston, US, Thermo Fisher is a major producer of scientific instrumentation, diagnostics, reagents, and other materials for academics, researchers, government, healthcare, and life sciences industry.
The company offers pharmaceutical solutions for drug development, clinical trial logistics, and commercial production to consumers of all sizes through its Patheon brand.
It provides scientific and technological excellence, including advanced skills for highly potent and controlled drugs, expertise in virus vectors, aseptic filling and lyophilisation, complex formulations, enhancement of solubility and difficult active pharmaceutical ingredients (APIs) to produce.
It also offers integrated drug development services that align drug and drug product development through a coordinated drive towards proof of concept that can minimise timelines for drug development.
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