AbioWave® Rocking Single-Use Bioreactor

Overview

The AbioWave® Rocking Single-Use Bioreactor is an engineered platform for scalable, low-shear mammalian and stem cell culture under controlled physiological conditions. It operates on the principle of orbital rocking motion—generating gentle, wave-like fluid displacement within a sterile, pre-sterilized single-use bag—to achieve efficient mass transfer (O₂, CO₂, nutrients, metabolites) without mechanical agitation. Unlike stirred-tank bioreactors, the AbioWave eliminates impeller-induced hydrodynamic stress and gas-liquid interface-associated foaming or bubble-mediated cell damage—critical for shear-sensitive cells such as human pluripotent stem cells (hPSCs), primary T cells, and recombinant CHO lines. Its design bridges process development and clinical/commercial manufacturing, supporting seamless transition from bench-scale R&D to cGMP-compliant production batches.

Key Features

• Industrial-grade Siemens S7-1500 PLC controller with deterministic real-time performance and integrated safety logic
• 13.5-inch capacitive touchscreen HMI developed with NetSCADA, supporting multi-level user roles, electronic signatures, and full audit trail per FDA 21 CFR Part 11 requirements
• PID-based closed-loop control of temperature, dissolved oxygen (DO), pH, and weight—with cascade configuration capability and configurable alarm thresholds (e.g., high-high, low-low)
• Three operational control modes: pH/DO feedback mode, total gas flow mode, and CO₂ concentration mode—enabling precise adaptation to fed-batch, perfusion, or attachment-dependent protocols
• Modular tray system accommodating standardized AbioBag® single-use bags in 10 L, 25 L, and 50 L nominal volumes—with working volumes ranging from 1 L to 25 L
• OPC UA–compliant architecture enabling interoperability with third-party SCADA systems, analytical instruments (e.g., inline pH/DO probes, mass spectrometers), and enterprise MES/LIMS platforms

Sample Compatibility & Compliance

The AbioWave supports suspension and adherent cultures across diverse cell lineages—including CHO, HEK293, CAP-T, insect (Sf9, Sf21), plant, and human mesenchymal/stem cells—under batch, fed-batch, and continuous perfusion configurations. All AbioBag® bags are manufactured from a proprietary 7-layer coextruded film (320 µm total thickness), animal-component-free, and certified USP Class VI and ISO 10993–compliant for cytotoxicity, sensitization, and intracutaneous reactivity. The innermost layer is ultra-low-density polyethylene (ULDPE), ensuring superior biocompatibility, flexibility, and extractables profile suitable for clinical-grade cell therapy manufacturing. Each bag undergoes validated gamma irradiation (25–45 kGy), arrives terminally sterilized, and includes full material traceability documentation—reducing validation burden and eliminating autoclave cycles or CIP/SIP infrastructure.

Software & Data Management

The AbioWave integrates natively with AbioPIMS™ (Process Information Management System), a GxP-aligned data acquisition and workflow orchestration platform. AbioPIMS provides centralized monitoring of multiple bioreactors across sites, with secure role-based access (Operator / Supervisor / Administrator), time-stamped audit trails, electronic signature enforcement, and 21 CFR Part 11–compliant record retention. It supports both periodic and event-triggered data logging, configurable alarm strategies, and synchronized multi-batch trend analysis (up to 8 concurrent runs). Built-in calculation modules enable real-time derivation of critical process parameters (e.g., OUR, CER, qO₂) without custom scripting. Data export is compliant with ALCOA+ principles—ensuring Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available records for regulatory submissions and internal quality audits.

Applications

• Early-stage process development and clone screening under physiologically relevant low-shear conditions
• Seed train expansion for mAb, viral vector (AAV, lentivirus), and CAR-T manufacturing
• Stem cell differentiation and expansion in xeno-free, serum-free media formulations
• Perfusion-based high-density culture for secreted therapeutics (e.g., exosomes, cytokines)
• Supporting Phase I–III clinical supply under cGMP environments with full traceability and change control
• Technology transfer between R&D labs, CMOs, and in-house manufacturing facilities

FAQ

What sterilization method is used for AbioBag® bags?
All AbioBag® bags are terminally sterilized using validated gamma irradiation (25–45 kGy) and supplied ready-to-use.
Does the AbioWave support perfusion culture?
Yes—the system supports continuous perfusion via integrated pump modules and compatible tubing sets, with programmable feed/perfusion rates and real-time weight-based feedback control.
Can AbioPIMS connect to non-Applitech bioreactors?
Yes—AbioPIMS features OPC UA client functionality and supports protocol translation for integration with Applikon my-Control®, ez2-Control®, and other third-party bioreactor controllers.
Is AbioPIMS qualified for use in regulated environments?
Yes—AbioPIMS is designed and documented to meet FDA 21 CFR Part 11, EU Annex 11, and ICH GCP/GMP data integrity requirements, including electronic signature validation, audit trail review, and system access controls.
What is the maximum working volume supported by the AbioWave platform?
The AbioWave supports up to 25 L working volume using the 50 L nominal AbioBag®, with optimized mixing and gas transfer performance across the full scale range.