OmniaBio is a contract development and manufacturing organization specializing in the production of gene-modified cell therapies and lentiviral vectors, facilitating the transition from preclinical development to commercial-scale manufacturing. The company addresses the need for efficient and reliable manufacturing processes in the cell and gene therapy sector, ensuring that life-changing therapeutics reach patients effectively.
Funding
Funding not disclosed
Founders
Product
Problem
The cell and gene therapy field faces challenges in scaling production from preclinical stages to commercial manufacturing, often encountering bottlenecks in efficient and reliable manufacturing processes. This can delay the delivery of potentially life-saving therapeutics to patients.
Solution
OmniaBio is a contract development and manufacturing organization (CDMO) focused on cell and gene therapies, offering services from early process development through GMP commercial manufacturing. The company leverages advanced technologies, including AI and automation, within a Good Manufacturing Practices (GMP) environment to enhance cell and gene therapy production. OmniaBio specializes in platforms for induced pluripotent stem cells (iPSC), lentiviral vectors (LVV), and immune cell-based therapies. By integrating these platforms with comprehensive analytical development and regulatory support, OmniaBio aims to streamline the path to market for transformative treatments, ensuring scalability, cost-effectiveness, and regulatory compliance.
Target Audience
OmniaBio serves biotech companies, pharmaceutical firms, and research institutions involved in developing cell and gene therapies, from early-stage development to commercialization.
Features
- Process development and optimization for cell and gene therapies, focusing on robustness and scale-up
- Analytical development services for tailored and established assays
- GMP manufacturing in Grade B or Grade C suites, compliant with U.S., Canadian, and European regulations
- Commercial manufacturing with efficient scalability and timely QC release
- Autologous cell therapy manufacturing integrating closed-unit systems, AI models, and robotics
- Cell banking services
- Regulatory guidance throughout the product lifecycle
- Supply chain security measures