Cobetter Irradiated ATF Hollow Fiber Products

Suspended cell culture technologies primarily encompass three mainstream modes: perfusion culture, fed-batch culture, and batch culture. Currently, the domestic biopharmaceutical industry employs fed-batch culture as the primary production method. However, perfusion processes are gaining increasing attention due to their distinct advantages. Compared to fed-batch systems, perfusion systems enable faster seed cell expansion and maintain long-term stability of high-density cell cultures during the N stage.

By enabling real-time product harvest, perfusion processes significantly enhance production efficiency. Furthermore, this approach ensures consistent product quality while reducing capital investments in production facilities and ancillary equipment.

The core of perfusion technology based on hollow fiber systems lies in establishing a closed cultivation system that integrates an ATF hollow fiber column, tangential flow control systems, and bioreactors. This system effectively retains cells within the cultivation vessel and employs intermittent or continuous medium exchange strategies to create an optimized microenvironment for cell growth.

Under this refined system, the exponential growth phase of cells is significantly prolonged, leading to a substantial increase in target product yield per unit time. By selecting hollow fiber components with specific pore sizes tailored to process requirements, the system can achieve either continuous product harvest or periodic bulk collection.

Cobetter is committed to addressing practical client needs and advancing the application of core membrane technologies in biopharmaceutical production, has recently launched gamma-irradiated sterile ATF hollow fiber assemblies. Designed to meet the diverse demands of biopharmaceutical companies, this product line comprehensively covers cultivation scales from 1L to 2000L.

Crucially, it is compatible with traditional glass reactors, stainless-steel bioreactors, and mainstream single-use bioreactor systems, offering a highly flexible perfusion solution for the biopharmaceutical industry.

This article introduces the basic specifications and application scenarios of Cobetter gamma-irradiated ATF hollow fiber product.

Typical Applications

Perfusion technology holds broad value across multiple fields:

Biopharmaceuticals:

High-density cell culture and product harvest for antibody drugs, vaccines, and cell/gene therapy (CGT) products, including:

• N-1 stage high-density seed cell preparation
• Continuous medium exchange and target product harvest in dynamic or continuous perfusion cultures
• Medium replacement during concentrated fed-batch cultivation
• Clarification and concentration of cell lysates

Food Industry:

• High-density cell/microbial cultivation for applications such as cultured meat and brewing.

Cobetter gamma-irradiated ATF hollow fiber product adopts an integrated design. When combined with compatible single-use tubing assembly, the system allows rapid post-unpacking operations—such as priming, vent, and integrity testing—under sterile conditions. It can then be aseptically connected to bioreactors for immediate use. A single operator can complete on-site installation without requiring equipment such as cleaning machines or autoclaves for sterilization.

Compared to steam-sterilized products, the gamma-irradiated series eliminates on-site cleaning, assembly, and high-pressure steam sterilization, drastically reducing pre-use preparation time, enhancing production efficiency, and ensuring batch success rates.

Cobetter gamma-irradiated ATF hollow fiber product offers a complete range of specifications (ATF2 to ATF10), each available in 0.2μm and 50 kDa molecular weight cut-off (MWCO) options, supporting process development from small-scale trials to full-scale production.

The priming process for all models eliminates organic solvents, requiring only purified water, water for injection, or culture medium, thereby minimizing operational risks and solvent residue concerns.

Product Diagram

Diagram of ATF 2 Gamma-Irradiated Assembly

Diagram of ATF 6 Gamma-Irradiated Assembly

Diagram of ATF 10 Gamma-Irradiated Assembly

Features

Performance Advantages

• 100% pre-shipment integrity testing ensures product reliability.
• Comprehensive product portfolio supports R&D to commercial-scale production.
• Overcomes cell density limitations of traditional batch/fed-batch processes while maintaining high cell viability.

User Convenience

• Ready-to-use design eliminates on-site assembly and sterilization, boosting efficiency.
• Portable configuration compatible with 1L–2000L single-use bioreactors.
• Organic solvent-free priming simplifies operations and reduces environmental impact.

Quality Assurance

• Low bioburden with no cytotoxicity risks.
• Compliance with biocompatibility and animal-derived component-free standards.

Quality Assurance

• ISO 9001:2015 Quality Management System
• Meet the requirement of USP <87> Class VI, Biological Reactivity Test, In Vitro (2020)
• ISO 7 cleanroom production
• Meets the requirement of USP <88> Biological Reactivity Test, in Vivo for Class VI plastics
• 100% product integrity test
• Aqueous extraction contains < 0.25 EU/mL as determined by Limulus Amebocyte Lysate (LAL), USP <85>
• ADCF raw materials, complies with FDA 21 CFR Part 177-182 (Indirect food additives)
• Particulate matter in injections meet the requirements in USP <788> for large volume parenterals
• Meets the requirement of ISO 11137 sterilization validation
• Product validation guide and COA available

Specifications

Ordering Information