Leveraging its comprehensive design and manufacturing capabilities in stainless steel and single-use systems, AUSTAR customized a Hybrid Fermentation System for the client. This system combines the durability of stainless steel with the flexibility of single-use technology, making it suitable for producing various biologics, including vaccines, monoclonal antibodies, and recombinant proteins.

• The system integrates functions such as media preparation, fermentation control, and online monitoring, enabling fully automated management from raw material input to output. This significantly enhances process stability and production efficiency. • Incorporating Process Analytical Technology (PAT) and Quality by Design (QbD) principles, the system uses high-precision sensors to monitor critical parameters (e.g., temperature, pH, dissolved oxygen) in real time. Dynamic adjustment strategies ensure optimal microbial metabolic conditions, substantially improving product yield. • The 4000L fermentation system adopts energy-efficient agitation and temperature control technologies, reducing energy consumption by over 30%. Integrated CIP (Clean-in-Place) and SIP (Sterilize-in-Place) functions minimize water and chemical usage, supporting sustainable production. Additionally, the system is compatible with ultrafiltration, depth filtration, and virus removal modules, further reducing waste emissions and complying with international environmental standards such as ASME-BPE. • Machine learning algorithms analyze historical process data to generate real-time production curves and optimize parameter adjustments, overcoming traditional reliance on manual expertise. This reduces human operational errors, increasing fermentation yield by 10%–15% while cutting operational costs by over 20%.