Sexton Biotechnologies Partners with BioSpherix to Create a Fully-Enclosed, Modular Fill-Finish System with Rapid Deployment

Sexton Biotechnologies has announced a new collaboration with BioSpherix Medical. As a tool and technologies partners of the Cell and Gene industry, Sexton and BioSpherix both recognize the need for cost-effective and flexible automation solutions during cell and gene therapy process development. While some upstream bioprocesses have been successfully automated, the final steps of downstream bioprocess, namely Fill-Finish, are often done manually with associated risks of contamination and user error. The inefficiencies and lack of traceable GMP controls make manual Fill-Finish processes unacceptable if companies are to scale up and scale out for late-stage clinical or commercial phases. The new collaboration will combine Sexton's off-the-shelf fill system, the Sexton Biotechnologies AF-500, with BioSpherix' exclusive Cytocentric® isolator technology, allowing rapid process development and implementation of GMP Fill-Finish. The recent global pandemic has resulted in an unprecedented acceleration of therapeutic candidates paired with significant supply chain challenges. Development of clinical and commercial stage manufacturing systems to meet this rapid expansion is likely to lead to significant delays in scale up and completion of clinical studies.