ARMI BioIndustries is the full-service development, manufacturing, and commercialization operation for the Advanced Regenerative Manufacturing Institute. We are dedicated to advancing the field of engineered cells, tissues, and organs. Our extensive range of services includes process development, deep tissue and material characterization, clinical manufacturing, regulatory compliance, and commercialization support.
At ARMI BioIndustries, we understand the unique challenges faced by therapy developers in the ever-evolving landscape of regenerative medicine. Our commitment to innovation and excellence are demonstrated through biofabfoundries. This groundbreaking approach makes it possible to automate and scale the manufacture of highly complex processes. ARMI BioIndustries specializes in process development and early-phase clinical trial manufacturing services for cells, tissues, and organs. We have amassed significant expertise in cell-based manufacturing, including:
- Development of cell type-specific, chemically-defined media.
- Scalable expansion of autologous and allogeneic pluripotent stem cells, multi-potent stem cells, and numerous primary cell types in closed, automated cell culture platforms.
- Application of scalable bioprocess equipment for cell and tissue handling.
- Automated seeding of synthetic and naturally-derived scaffolds.
- Custom-engineered systems for tissue and organ culture.
- Preservation strategies for in-process and final products under various temperature regimes.
- A Novel Tissue Foundry Approach
We work hand-in-hand with therapy developers to:
- Deconstruct, simplify, and adapt manufacturing processes to scalable, closed automation systems.
- Harness ARMI’s Deep Tissue Characterization Center to develop in-process and final product quality attributes, including potency, purity, and identity.
- Apply templated and phase-appropriate Quality Systems that evolve with product development.
- Design, test, and qualify product-specific, scalable, modular, automated, and closed systems.
Manufacturing cells, tissues, and organs is a challenging endeavor, often shrouded in the mystery of biological complexities. While the mechanism of action remains elusive in many cases, regulatory authorities demand that innovators pinpoint the product attributes (purity, potency, identity, and safety) driving clinical outcomes. ARMI | BioFabUSA is tackling this challenge by building A state-of-the-art Deep Tissue Characterization Center (DTCC), designed to empower innovators with critical insights necessary to manufacture high-quality products and meet rigorous safety and therapeutic efficacy requirements.
- Accelerating Development: We help shorten development timelines by identifying critical product attributes and process parameters applying Quality by Design (QbD) principles to process development.
- Mitigating Risk: We reduce risk by providing regulatory authorities with the expected information, establishing confidence in the product’s safety and efficacy.
- Ensuring Robust Processes: Our center assists in establishing robust, cost-effective processes by developing a control strategy based on an in-depth understanding of the critical process parameters that influence the essential quality attributes.
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Process Development Services
We offer process development specifically designed to meet the needs of regenerative manufacturing. The work conducted by this group is supported by our Deep Tissue Characterization Center, as well as our Tissue Foundry platform. It prioritizes process gaps analysis, simplification, optimization and eventual automation.