Pilot and GMP Bioreactor

AbioPilot Stainless Steel

With nearly 20 years of innovation in bioprocess technology, Applitech has developed the AbioPilot SS series to meet the needs of modern biotechnology applications. These modular stainless-steel bioreactor systems support both mammalian cell culture and microbial fermentation processes, with standard pilot-scale vessels ranging from 20 to 200 L.

For larger-scale manufacturing, Applitech offers fully customized systems with capacities up to 20,000 L. All AbioPilot SS systems are designed in accordance with ASME BPE standards and support GMP and GAMP requirements, providing a scalable and regulatory-compliant solution from process development to commercial production.

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An advanced line of single-use bioreactors supplied in 50 L, 200 L, 500 L, 1000 L, and 2000 L sizes. Standard configurations and fully customized versions are designed to support a wide range of cell culture applications, including antibody production, vaccines, and cell & gene therapies.

Standard features include dual-jacketed bag holders, a rugged stainless steel support frame, a sight window, 5-layer coextruded bag films, dual marine impellers, and standard sensor ports or integrated single-use sensors.

Main Features

• Dual-jacket design. Temperature range 8°C–40°C ±0.1°C with integrated TCU
• Jacketed single door with observation window
• Sensor location mirroring standard SS vessels. Up to 4 single-use or traditional sensors (pH, DO, etc.)
• Modular, small-footprint controller provides high flexibility for a wide application range in sizes from 50 L to 2000 L
• Seamless integration with external equipment, including variable-speed pumps, MFCs, scales, off-gas analyzers, automated sampling systems, etc.

• Wide selection of standard sizes, including 50 L, 200 L, 500 L, 1000 L, and 2000 L. Other sizes on request.
• Advanced manufacturing in Applitech’s ISO 7 cleanroom for highest sterility and full certification.
• Comprehensive quality system, including visual inspection, heat-seal strength testing, and endotoxin assessment.
• Single-use axial-flow impellers for best mixing performance in mammalian cultures.
• Microbial configuration with single-use Rushton impellers.
• Standard ports for exhaust connection, overlay gas inlet, pH/pO2/pCO2/temperature sensors, and liquid transfer or sampling.
• Flexible bag design allows customization to fit specific process requirements.

Film Technology

In the five-layer Renolyt film structure, each layer serves a specific function to optimize product integrity, durability, longevity, and sterility:

• Layer 1 (50 µm): HDPE outer layer, which provides superior mechanical strength and resistance to external factors.
• Layer 2 (10 µm): Thermoplastic interlayer elastomer (TIE) bonding layer for structural integrity, preventing delamination.
• Layer 3 (20 µm): Ethylene vinyl alcohol (EVOH) is the gas barrier, blocking O2, CO2, and moisture transmission.
• Layer 4 (10 µm): A second thermoplastic interlayer elastomer (TIE) bonding layer, preserving flexibility and structural integrity.
• Layer 5 (230 µm): Ultra-low-density polyethylene (ULDPE) is the process contact layer. It delivers exceptional heat sealing, low-temperature resistance, and an inert chemical profile, minimizing extractables and leachables.

Top-mounted mixing systems with adjustable motor speed for accurate control. Designed for buffer and media preparation, intermediate products, and finished products. Systems are highly customizable, including optional modules for pH, conductivity, temperature, and weight control, or interfaces for external pumps and ancillary equipment.

Features a user-friendly touchscreen HMI, a wide variety of mixing impellers, and compatibility with either plastic or stainless-steel drums.

State-of-the-art single-use magnetic mixing systems available in capacities from 50 L to 3,000 L. Designed for maximum flexibility, the systems can be configured with optional modules for pH, conductivity, temperature, and weight monitoring and control, as well as interfaces for external pumps and process equipment. A user-friendly 7″ touchscreen HMI provides intuitive operation, while multiple communication protocols, including OPC, enable seamless integration with automation platforms.

Advanced multi-user software supports electronic batch records, historian functions, alarms, trending, and comprehensive data management. The versatile design is suitable for a wide range of bioprocess applications, including buffer and media preparation, solution hold and storage with temperature control, virus inactivation, formulation, and final product preparation.