Single-Use Bioreactor

Our single-use bioreactor system, utilizing medical-grade COC/COP sterile membranes, is designed to meet the stringent demands of modern biopharmaceutical manufacturing—from monoclonal antibodies and vaccines to gene therapy vectors. Certified to USP Class VI and ISO 10993, it ensures full compliance with global regulatory standards, enabling seamless cross-border sales without regulatory barriers.

Each unit is delivered in pre-sterilized, individually packaged form, sterilized via gamma irradiation to achieve a Sterility Assurance Level (SAL) of 10⁻⁶, ensuring immediate usability without the need for additional cleaning validation. This eliminates the risk of cross-contamination, making it ideal for multi-product facilities where GMP guidelines mandate avoiding product mix-ups. The low protein adsorption rate of less than 0.05% ensures that biological efficacy and purity are maintained throughout processing.

The reactor’s flexible membrane design supports volumes ranging from 100 mL to 5000 L, accommodating all stages from R&D to clinical production. Integrated aseptic connection ports facilitate operations such as feeding, sampling, and harvesting without requiring an aseptic chamber environment. A disposable stirring system (magnetic or pneumatic mixing) operates at <50 W/m³ to minimize shear stress, suitable for delicate cell cultures like stem cells.

Featuring high-efficiency aeration systems (membrane sparging or microbubble diffusion), the system achieves a kLa value of 200 h⁻¹, critical for high-density cell culture. Built-in sensors monitor temperature, pH, and dissolved oxygen in real-time, maintaining control within ±0.5°C and ±0.1 pH units respectively. The foldable design reduces storage space by 90% compared to stainless steel reactors, significantly lowering warehousing costs.

Supporting various process modes including perfusion, fed-batch, and batch culture, this system adapts to diverse biopharmaceutical production needs. Batch changeover takes less than two hours, drastically reducing downtime compared to traditional reactors. With no need for CIP/SIP validation, development cycles can be shortened by 6-12 months, accelerating time-to-market for new drugs.

Initial investment costs are approximately one-third of those associated with stainless steel reactors, making it an attractive option for startups and companies aiming for lean asset operation. Additionally, there are no cleaning, sterilization validation, or spare parts maintenance costs, reducing fixed operational expenses. The elimination of contamination risks due to incomplete cleaning results in production yields exceeding 99%.

This system is particularly well-suited for sensitive cell lines such as CHO, HEK293, insect cells, and viral vectors, covering applications from monoclonal antibodies to gene therapies and vaccines. It fully complies with GMP Annex 1 requirements for aseptic production, especially beneficial for high-potency drugs like ADCs. By supporting small-batch custom production, it aligns perfectly with the precision medicine trend, facilitating personalized therapies like CAR-T.

With a global supplier network (e.g., Cytiva, Thermo Fisher), stable supply chain management is assured, minimizing disruption risks. Low training requirements enable operators to become proficient after just two hours of instruction, further reducing labor costs. Waste materials can be professionally recycled, adhering to EU RoHS and WEEE regulations, enhancing corporate ESG profiles.