NOVO’s client Synthetic Genomics has partnered with immunotherapy development company Advaxis to establish the first current good manufacturing practice (cGMP) synthetic biology facility for the production of synthetic DNA constructs; specifically, plasmid DNA for deployment in personalized oncology treatment. The cGMP suite, which meets FDA guidelines for Phase 1 clinical quality and manufacturing requirements, is based on SGI’s BioXP 3200 benchtop DNA printer, an award-winning system, which NOVO helped SGI to develop.
Advaxis’s ACXS-NEO personalized oncological immunotherapy treatment, developed under collaboration with Amgen, targets specific neoepitopes found in individual tumors. Immunotherapy works with the patient’s immune system to recognize and target tumor-specific antigens without compromising the immune system or causing harm to healthy cells. Genetic variants in a patient’s tumor are identified to determine the best possible course of treatment.
Using SGI’s BioXp 3200 System, genetic sequences of these tumor-specific epitopes are then quickly converted into synthetic DNA to create plasmid DNA for deployment in personalized therapy. The BioXp 3200 has brought the manufacturing process time down from months to weeks, an obvious benefit in personalized medicine.
The facility is located at SGI-DNA, a subsidiary of SGI, in La Jolla, California. Advaxis has been given permission to proceed with Phase 1 clinical trials by the FDA, and expects to begin the trials later this year.