HIGUCHI INC. Product Lineup

Single-use assembly tubes for biopharmaceuticals. Tube material, length, connector type, filters, etc. can be customized according to customer requirements. Manufactured in a Class 7 cleanroom. The facility is ISO 13485 and FDA certified. Compatible with gamma sterilization, with various certificates included.

AsptiBag Gold uses an inactive multilayer polyethylene film that is physically robust and inert to many chemicals and solvents, while also possessing excellent gas barrier properties. The contact surface is made of 130μm ultra-low-density polyethylene without any additives. It meets various regulatory and functional requirements, providing consistently high-quality products.

The disposable sampling port cartridge eliminates the need for time-consuming assembly of multi-port adapters. This allows for direct attachment to the container's port, creating a simple, fast, and immediately usable sampling system. It is a gamma-irradiated disposable system for aseptic liquid sampling at various stages of pharmaceutical and biopharmaceutical processing. These systems minimize the potential for false positives compared to traditional sampling systems and reduce the need for cleaning. A sealed system that maximizes operator safety and eliminates contamination. A simpler, faster, and completely disposable ready-to-use solution for sampling applications. There is no need for the cumbersome and time-consuming assembly of sampling system ports and multi-port adapters within the cartridge.

The SafeCell series is made of fluorinated ethylene propylene (FEP) and meets the demands of in vitro cell culture. FEP is chemically and biologically inert, making it perfectly suitable for cell suspension culture. Its anti-adhesion properties allow cells to freely float and proliferate in the medium. SafeCell bags are permeable to gases (oxygen, carbon dioxide, nitrogen), enabling the necessary exchanges for proper cell development, while also possessing another important characteristic: water impermeability. The low evaporation rate of SafeCell bags prevents issues even in humid incubators that increase the risk of bacterial and microbial growth.

The combination of deep filtration and alluvial filtration allows for the removal of CHO cells, bacteria, etc., in a single step without the need for a centrifugation step. This reduces the cost and downtime of the bioprocess.

Advanced Microdevices' sterilizing capsule filter achieves improved throughput through a pre-filter and high flow rates due to low hold-up volume. 【Features】 ■ Improved recovery rate due to low protein adsorption ■ Assurance of microbial capture performance through bacteria challenge testing ■ 100% integrity testing conducted ■ Certificate provided with each filter ■ Compatible with ethylene oxide and autoclave sterilization ■ Gamma radiation sterilization compatible

Consistent product quality using a quality management system Establishment of product traceability through lot number management Validation support through integrity tests, extractables, leachables, adsorption, and testing Compliance with various regulations such as FDA and USP Autoclave, steam sterilization Sterilization varies by each filter For details, please contact us

In the pharmaceutical manufacturing industry, there is a constant demand for the optimization of manufacturing processes and cost reduction. In particular, reducing the risk of contamination and minimizing the time and costs associated with cleaning and sterilization are critical challenges. Our 3D single-use mixer bags for biopharmaceuticals address these challenges. 【Usage Scenarios】 - Liquid filling lines - Cell culture - Buffer preparation - Medium mixing 【Benefits of Implementation】 - Reduction in cleaning and sterilization costs - Decrease in the risk of cross-contamination - Optimization of manufacturing processes

MDI AseptiBag LT is designed for cold chain applications in biopharmaceuticals. It supports low-temperature storage down to -80°C and is suitable for multiple freeze-thaw cycles involving high-value pharmaceutical raw materials and process intermediates. Additionally, it is made of low-extractable ULDPE film, which provides excellent durability to maintain integrity even in sub-zero environments during freezing, storage, transportation, and thawing processes. 【Benefits of Implementation】 - Supports low-temperature storage down to -80°C, maintaining the cold chain - Protects the quality of high-value pharmaceutical raw materials and process intermediates - Offers durability to maintain integrity even in sub-zero environments

In the biotechnology industry, the stable supply and quality maintenance of culture media are essential for the success of research and development. In particular, managing the risk of microbial contamination and preventing the loss of expensive culture media are significant challenges. Our gamma-sterilized bottle assembly addresses these challenges, enabling safe and efficient transfer, sampling, and storage of culture media. 【Usage Scenarios】 - Research and development of biopharmaceuticals - Cell culture processes - Sampling and storage of reagents 【Benefits of Implementation】 - Reduction of microbial contamination risk - Safe transfer and storage of culture media - Increased efficiency in sampling tasks

In the pharmaceutical industry, particularly in antibody production, the stability and reproducibility of cell culture are directly linked to product quality. From the initial stages such as medium optimization and clone selection to the process development of biopharmaceuticals and ultimately to GMP production, consistent quality control and efficient culture are required. An inappropriate culture environment can lead to decreased productivity and variability in quality. The WAVE bioreactor is designed to address these challenges, accommodating a variety of cells and being widely applicable from research purposes to intermediate scales. 【Usage Scenarios】 - Culture of mammalian cells, plant cells, insect cells, microbial cells, and stem cells - Clone selection, medium optimization - Process development of biopharmaceuticals - GMP production 【Benefits of Implementation】 - Efficient culture of diverse cells - Wide applicability from research purposes to intermediate scales - Maintenance of culture environment with multi-layer films that have excellent barrier performance - Reduced impact on cells due to a structure with minimal extractables - Monitoring of culture conditions using pH sensors and DO sensors