Creative Biolabs utilizes advanced genetic engineering strategies to optimize C. novyi-NT strains for enhanced efficacy. We facilitate the precise knockout of residual virulence factors or the insertion of expression cassettes for therapeutic antibodies, cytokines, or prodrug-converting enzymes. This transforms the bacterium into a highly specific vector, improving its oncolytic potency and safety profile.
Recognizing the strict anaerobic requirements of C. novyi-NT, we establish customized high-density fermentation processes. Our experts precisely regulate parameters—including redox potential, temperature, and nutrient feed rates—to maximize biomass accumulation. Crucially, we implement strategies to induce high-efficiency sporulation, ensuring superior survival rates and yield consistency across production batches.
We develop robust downstream isolation and purification protocols tailored for C. novyi-NT. Our primary objective is the efficient removal of vegetative cells, cellular debris, and residual media components from the fermentation broth. This ensures the recovery of high-purity, research-grade spores that meet stringent criteria for subsequent formulation and preclinical application.
Our team engineers advanced formulations designed to maintain the long-term stability and high germination rates of C. novyi-NT spores. We focus on developing liquid or lyophilized preparations suitable for intratumoral or intravenous administration. This involves the rigorous screening of cryoprotectants and excipients to preserve biological activity during storage and transport.
To validate efficacy, we simulate the tumor microenvironment in vitro, specifically mimicking hypoxic conditions to test C. novyi-NT colonization and Mechanism of Action (MoA). Services include evaluating spore germination rates under hypoxia, quantifying direct oncolytic activity against specific cancer cell lines, and assessing the bacterium’s ability to disrupt the dense tumor stromal matrix.
We evaluate the potential of C. novyi-NT to induce potent anti-tumor immune responses. Through co-culture assays with immune cells such as macrophages and T-cells, we analyze cytokine release profiles and activation markers. These data help verify the strain's ability to convert an immunosuppressive "cold" tumor microenvironment into an immunogenic "hot" phenotype.
Creative Biolabs provides comprehensive safety evaluations to ensure the attenuation status of C. novyi-NT strains. Our testing protocols include screening for virulence factors (e.g., confirming the absence of the α-toxin gene), analyzing genomic stability over multiple generations, and determining antibiotic susceptibility profiles to exclude unintended toxicity risks in research models.
We establish standardized biological assays to quantify the active potency of C. novyi-NT preparations. Utilizing in vitro cell killing assays or specific biochemical markers, we precisely measure the anti-tumor activity of each batch. This data provides the essential foundation for Quality Control (QC) and ensures consistency for batch release in preclinical studies.
