This company develops microfluidics devices and T-mixers for lipid nanoparticle (LNP) formulation. Their technology streamlines the LNP formulation process, helping biotechnology researchers accelerate the development of therapeutics.
Funding
Funding not disclosed
Founders
Product
Problem
Developing effective lipid nanoparticle (LNP) formulations for novel therapeutics is often hindered by inefficient screening processes and limitations in scaling production from research to commercial levels. Traditional methods lack the throughput and control needed to optimize LNP composition and manufacturing parameters effectively.
Solution
XGen Bio provides a suite of microfluidics-based instruments and T-mixers designed to streamline LNP formulation, screening, and production. Their INano™ and XNano™ families of products offer solutions for high-throughput screening, rapid nanomedicine preparation, and GMP-compliant commercial manufacturing. These systems enable researchers and manufacturers to optimize LNP formulations, ensure batch-to-batch reproducibility, and seamlessly scale up production from early-stage research to clinical and commercial applications. XGen Bio's technology supports the development of gene therapies, vaccines, and other LNP-based medicines by providing precise control over key process parameters and integrating upstream and downstream processes.
Target Audience
XGen Bio serves bioengineers, formulators, and pharmaceutical manufacturers involved in developing and producing LNP-based therapeutics, including mRNA vaccines, gene therapies, and nanomedicines.
Features
- INano™ HT-Smart: An end-to-end high-throughput workstation for automated lipid mixing and purification of mRNA-LNP formulations, enabling in vivo and in vitro screening.
- INano™ L+: A rapid nanomedicine preparation system for early-stage formulation screening and scale-up process development, supporting preparation volumes from 0.4mL to 60mL.
- INano™ Optimux: A GMP-compliant, multifunctional continuous nanomedicine preparation system for automated process development and GMP production of clinical-stage products, supporting volumes from 0.3 mL to 100 L.
- INano™ S: A GMP-compliant commercial-scale production system integrating LNP encapsulation and tangential flow filtration (TFF) for continuous and automated manufacturing.
- Compatibility with various mixing structures, including microfluidic mixers, T-mixers, and customized mixers, maximizing flexibility in formulation development.
- Automated CIP/SIP (cleaning in place/sterilization in place) systems for enhanced compliance and efficiency in GMP environments.
- I-Control algorithm and I-Sensor flow rate sensor for precise flow rate accuracy and pulse stability.
- Software compliant with FDA 21 CFR Part 11, featuring multi-level user access management, audit trails, and electronic signatures.