Bio-Process Control

The impetus for Process Analytical Technologies (PAT) in biomanufacturing is driven primarily due to its benefit to introduce well-designed and well-understood manufacturing processes, thereby allowing the continuous improvement of product quality towards the desired state. However, the continuous in-line monitoring of key process attributes, a prerequisite for product quality and process optimization, remains a substantial hurdle. InSens4™, an in-line multi-analyte sensor probe that can simultaneously monitor Glucose, Lactate, Osmolality, and pH values during biologics production. The patent-protected base technology is expandable to other analytes in the production of biologics, including large molecules (i.e., proteins titer) with minimal development work in the future. The sensor platform is based on a revolutionary marriage of widely-researched sensing materials (i.e., smart hydrogels) with an elegant magnetic transduction mechanism. The resulting sensors are cost-effective and are accompanied by operator-friendly software. It is compatible with gamma and autoclave sterilization methods. The 12mm probe design fits industry-standard ports on all major bioreactors, allowing for the scalability of processes from the laboratory to the manufacturing floor. This sensor technology will enable biopharmaceutical companies to improve process robustness, accelerate scale-up to commercial production, and allow more efficient use of resources