Thermo Fisher Scientific has opened a 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.
Opened in July 2021, the manufacturing facility will allow the company to satisfy rapidly increasing demand for plasmid DNA-based therapies and essential mRNA-based vaccines.
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Details of Thermo Fisher Scientific’s Plasmid DNA manufacturing site
The 67,000ft2 plasmid DNA manufacturing facility is located on Thermo Fisher’s Carlsbad campus, a ‘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 facility features 1,000ft2 of development space, quality control (QC) labs covering 3,000ft2, and 14,000ft2 allocated to cGMP suites. It offers process development, QC and analytical, and cGMP manufacturing services.
The state-of-the-art production facility incorporates 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 is strategically equipped to offer comprehensive end-to-end cell and gene therapy capabilities and expedite the commercialisation of plasmid-based medicines and vaccines.
The site is also capable of developing large-scale plasmid DNA as the primary drug material for DNA therapy.
The facility complements 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.
cGMP plasmid DNA is used as a critical raw material for the manufacturing of life-saving cancer treatments, as well as mRNA vaccines.
Details of plasmid DNA isolation
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 30 years 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 the robust purification of plasmid DNA in the volume and purity needed for the downstream application of interest.
The advantages of plasmid DNA include low immunogenicity, improved safety, and ease of manufacture. This has resulted in a significant increase in global demand for materials and manufacturing capacity.
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.
The 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 through an 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.
Marketing commentary on Thermo Fisher Scientific
Based in Boston, Massachusetts, Thermo Fisher is a major producer of scientific instrumentation, diagnostics, reagents and other materials for academics, researchers, government, healthcare, and the 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.
Thermo Fisher provides scientific and technological excellence, including advanced skills for highly potent and controlled drugs, expertise in virus vectors, aseptic filling and lyophilisation, complex formulations, the enhancement of solubility, and active pharmaceutical ingredients (APIs) that are difficult to produce.
The company also offers integrated drug development services that align drug and drug product development through a coordinated drive towards proof of concept, which it claims can minimise timelines for drug development.
