Full view of the 2200 L fermenter in a GMP manufacturing area to produce plasmidDNA biopharmaceuticals
An operator trained in GMP conditions and wearing the recommended equipment, is checking the inside of the fermenter tank
An operator trained in GMP conditions is checking centrifugation parameters on the touchscreen of the device
Attractive cost of goods gives plasmid DNA commercial path forward and positions Kaneka Eurogentec as the premier supplier for plasmid DNA
— Lieven Janssens, CEO of Kaneka Eurogentec
SERAING, BELGIUM, July 4, 2024 /EINPresswire.com/ — Kaneka Eurogentec sets new benchmark in plasmid DNA manufacturing with the production of 1 kg of plasmid DNA
Attractive cost of goods gives plasmid DNA commercial path forward and positions Kaneka Eurogentec as the premier supplier for plasmid DNA.
Kaneka Eurogentec, an FDA inspected CDMO focused on the production of injectable grade cGMP biopharmaceuticals, announced the manufacture of 1 kg of plasmid DNA, in a single batch, for a major drug development company.
The achievement is remarkable for its efficiency in producing 1 kilogram of plasmid DNA from a single fermentation run. The product quality was confirmed to be above the customer’s specifications and greenlights the commercial supply potential of Kaneka Eurogentec’s cGMP production capability.
Key Accomplishments:
1. Scale-up of fermentation, lysis and purification technology to kg-scale as a single batch
2. Active form of product purified higher than customer’s target specification
3. Reduction of supply costs by minimizing purification to a single chromatography step to purify all the plasmid material.
Lieven Janssens, CEO of Kaneka Eurogentec, stated “This successful production opens commercial opportunities for plasmid DNA drug development companies, both in the field of DNA vaccines and non-viral gene therapy. The efficiency of the production platform changes the economics of launching a plasmid DNA based drug.”
Plasmid DNA has significant potential for:
1. Non-viral gene therapy by delivering specific genes into patient’s cells
2. Vaccination by introducing the necessary DNA sequence for antigen production and triggering the necessary humoral and cellular immune response.
3. Cancer therapy by delivering cytokines that stimulate the immune system to attack cancer cells, inhibit tumor growth or induce apoptosis in cancer cells.
4. Use as a starting material for viral vector and mRNA based therapies.
All plasmid DNA benefit from rapid design, an excellent safety profile, thermal stability and platform manufacturing. The ability to manufacture plasmid DNA at large scale further enhances its potential for clinical advancement and commercial supply.
Kaneka Eurogentec SA, part of the Kaneka group, is a contract development and manufacturing organization providing custom products and services to researchers in the biological sciences, diagnostic and biopharmaceutical industries. With a commitment to excellence, the company operates under ISO 9001, ISO 13485 and cGMP quality systems. Eurogentec’s business units fully support research, diagnostic and drug development projects from early R&D to commercial phases. Headquartered in Belgium, and with strategically located subsidiaries worldwide, the Eurogentec Group employs a team of 500 people.
Kaneka is an innovation-oriented chemical company. Traditionally the company has been active in polymers, fermentation, biotechnology and electronics, as well as other fields. Business activities now span a broad spectrum of markets ranging from plastics, EPS resins, chemicals and foodstuffs to pharmaceuticals, medical devices, electrical and electronic materials and synthetic fibers. The life science related activities are currently one of the strategically important domains for Kaneka. The company has been a pioneer among Japanese chemical companies in establishing overseas operations, beginning in 1970 with a subsidiary in Belgium.
Frédéric Dimola
Eurogentec
+32 496 74 51 57
f.dimola@eurogentec.com
Unveiling Kaneka Eurogentec GMP Plasmid DNA Manufacturing Process
