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INano™ Optimux

Medium-Scale Formulation (Reusable System & GMP Compliant)

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INano Family/ INano™ Optimux

Overview
Capabilities
Video
Resources

Overview

INano™ Optimux is a highly versatile, GMP-compliant, multifunctional continuous nanomedicine preparation system. It supports automated process development for scaling up nanomedicines like LNPs and facilitates GMP production of clinical-stage products. Whether it’s large-scale process development for early CMC studies or upstream or downstream process research, this system can do it all with unparalleled flexibility and reliability.

Designed based on the QbD (Quality by Design) concept, it allows exploration of a broader range of key process parameters, such as flow rate ratio, total flow rate, dilution flow rate, and types of dilution liquids
Supports a wide range of preparation volumes: 0.3 mL to 100 L
Flexible choice between microfluidic mixers, T-mixers, and various customized mixers
Includes an automated CIP/SIP (cleaning) system, offering full audit tracking for enhanced compliance and efficiency
Supports fully automated sequencial screening of different process parameters and automatic sample collection into separate vials
The unique I-Control algorithm, combined with the I-Sensor flow rate sensor, ensures flow rate accuracy, pulse stability, and reliable “what you see is what you get” performance
The entire system design and manufacturing comply with GMP standards, and the software meets FDA 21 CFR Part 11 requirements. Comprehensive GMP validation documents and activities are also provided

Capabilities

Multiple Mixing Methods

As a platform device, the INano™ Optimux not only supports microfluidic/T-mixer cartridges but also allows for custom cartridge designs based on customer requirements and offers a variety of cartridge materials to choose from.

Intelligent Process Screening

INano™ Optimux is equipped with an automated clean in-place (CIP) system, an automated sample collection system, and an automated perfusion system. Users can perform automated screening based on different process conditions during process development, significantly accelerating development speeds.

Flexibly Adapt to Different Production Scales

INano™ Optimux supports micro-volume preparation with a minimum of 300 μL and GMP production up to 100 L. Its unique patented control algorithm can limit waste liquid volume to ≤ 50 mL*.

Powerful Automatic CIP System

Traditional LNP preparation equipment requires manual cleaning and endotoxin control, with frequent changes of cleaning solutions. This process is tedious and lacks system recording, posing significant compliance challenges. The INano™ Optimux integrates an automatic CIP system, enabling a truly hands-free, fully automated process with complete system documentation, allowing you to say goodbye to the dilemma of "3 hours of cleaning, 10 minutes of preparation"!

Consistent Critical Quality Attributes (CQA) Can Be Achieved From Preclinical to Clinical Development

INano™ Optimux adopts the same scalable mixing structure as INano L⁺, ensuring the consistency of critical quality attributes (CQA) throughout the development process and significantly accelerating the technical transfer from process development to GMP production.

Regulatory Compliance

The equipment is meticulously designed and manufactured to comply with GMP, cGMP, and EudraLex regulations. Adherence to ASME and BPE standards ensures precision and quality throughout the process. Constructed with premium materials and components, the equipment delivers exceptional stability and reliability, meeting the highest industry standards.

Complete documentation and traceability

The equipment operating system is designed in strict compliance with FDA 21 CFR Part 11, featuring multi-level user access management, data-only recording, audit trails, electronic signatures, and more.

Video

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