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New standards for integrity testing machines that comply with the latest data integrity and QRM.

For more details, please contact us or download the PDF document.

Bioreactor system for cell line development and process optimization.

■ The new features improve the performance of applications such as the following: - Clone selection - Optimization of culture media and feeds - High-density culture processes - Media exchange and passaging in cell therapy applications ■ The new variable deck reduces operator downtime and improves operator efficiency ■ The new Amber clone selection software makes the best clone decision process easier ■ The new Generation 2 liquid handler enables faster and more precise operations, capable of complex tasks such as liquid mixing and addition in multifactorial design of experiments (DoE) ■ Ambr15 is the industry-standard micro-bioreactor system used in research facilities worldwide ■ The addition of metabolite analysis equipment enables a development approach in accordance with Quality by Design (QbD) ■ Ambr15 significantly reduces the amount of culture media and consumables, thereby lowering the cost per experiment, in addition to saving on facility space, funding, and labor ■ Ambr15 contributes to better clone selection on-site, more media selection, and faster process optimization

Introducing options and accessories that can be added to the Ambr 15 Generation 2.

For more details, please refer to the PDF document or feel free to contact us.

Single-use culture equipment that meets the requirements of the microbial culture process.

The Biostat STR 50 microbial culture adopts a proven vertical stirring design. The system consists of a bag holder, a control tower equipped with the new user interface Biobrain, and the industry-leading robustness, along with the Flexsafe STR bag designed for microbial culture.

Rapid at-line analysis chromatography solution

The PATfix pDNA analysis platform supports rapid process development and optimization, providing reliable in-process control for pDNA process development and manufacturing. PATfix pDNA is a high-performance HPLC (high-performance liquid chromatography) system that utilizes the unique analytical capabilities of the CIMac pDNA monolithic column to separate pDNA isoforms and multimers. It includes a user guide, validated methods, SOPs, and pDNA standard materials. The user-friendly PATfix software makes data processing, visualization, and sharing easy.

Fully automated tangential flow filtration system using a closed-loop single-use system suitable for process development to pilot-scale manufacturing.

Sartoflow Expert SU is a single-use TFF system that allows for configuration selection to accommodate various applications. In addition to cutting-edge TFF steps, processes such as 0.2 μm filtration and temperature-controlled mixing are incorporated into a single system. The ability to operate multiple processes together is extremely useful in the manufacturing of mRNA, pDNA, and ADC.

Technology for clarification of cell cultures and removal of impurities: Sartoclear Depth Filter

▪ Recovery of mammalian cell cultures ▪ Microbial lysis solution ▪ Removal of precipitates from plasma and serum ▪ Removal of particles and colloids from process intermediates ▪ Medium filtration

Please check the Japanese version catalog for a significant increase in operability and stirring power!

<Features> ▪ Providing unprecedented performance and quality assurance ▪ Control over the entire manufacturing process ▪ Quality assurance for fluid contact components ▪ Validation and quality assurance ▪ Guaranteeing the integrity of container closures ▪ Safe and reliable handling and shipping solutions from 5L to 500L ▪ Safe, self-expanding robust solutions

A robust, complete, and scalable solution for frozen storage and frozen transportation.

【Robustness confirmed down to -70℃】 ▪ A single-use freezing and thawing platform designed to maximize safety throughout the product lifecycle. ▪ Proven freezing and thawing performance protected by structural containers and complete logistics, with the S71 single-use bag validated through extensive low-temperature functionality qualification. ▪ The highest level of robustness enabling the frozen transport of expensive active pharmaceutical ingredients worldwide, validated according to ASTM D4169 Guarantee Level 1 (AL1). 【Meeting customers' needs for frozen storage and transfer】 Celsius PDS offers a range of general S71 films and all types of single-use containers that can be selected and scaled according to the process, from process development to clinical and commercial production. The feasibility can be easily assessed with process development tools.

Smart condition setting, a genuine end-to-end integrated freeze-thaw system.

Make smart decisions with Celsius Lab Scale Solutions ▪ Compatibility Create models that accurately simulate the temperature profiles of various freeze/thaw technologies. ▪ Scalability Use the same relevant materials for all Celsius commercial scale solutions (Celsius CFT, FFT, FFTp) to ensure reproducible freeze/thaw conditions. ▪ Versatile environmental settings The Celsius platform enables rapid, economical, and adaptable frozen transport for process development through diverse solutions.

Freeze-thaw solutions for seamless scalability to commercial production.

▪ Celsius CFT End-to-End Platform Celsius CFT (Controlled Freeze & Thaw) is a freezing and thawing system using plates with controlled freezing rates. It is a fully integrated end-to-end freezing and thawing solution that minimizes low-temperature concentration while reducing risks by minimizing the handling of active pharmaceutical ingredients. ▪ Celsius FFT: Stackable Freezing Container to Simplify Operations Celsius FFT (Flexible Freeze and Thaw) is a sterilized, pre-assembled freezing container that is ready for immediate use, featuring a unique bag-in-shell system that operates seamlessly within any conventional or blast freezer. ▪ Celsius FFTp: Single-Use Container Designed for Horizontal Plate Freezers Celsius FFTp (Flexible Freeze and Thaw for Plate Freezers) offers a unique bag-in-shell system while featuring a flat and more compact design that fits perfectly on the surface of horizontal plate freezers.