Fully-Enclosed Modular Fill-Finish System created by Sexton Biotechnologies and BioSpherix
Sexton Biotechnologies Partners with BioSpherix to Create a Fully-Enclosed, Modular Fill-Finish System with Rapid Deployment for Emerging Cell and Gene Therapy Needs
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.
BioSpherix, having already observed that traditional GMP capacity is becoming limited, leads the field in manufacture of modular systems that reduce the time and capital burden of implementation. While constructing and operating a Class A or B environment is time and cost-prohibitive for start-up companies, the BioSpherix solution offers an attractive solution to reduce the need for high classification cleanroom, long lead times, and costs.
“The limitations of many of the available downstream processing methods and systems are inherently obvious for cell and gene therapy developers,” said Sean Werner, President of Sexton Biotechnologies. “We’ve taken the approach with the AF-500 to have systems ready to ship so developers can immediately begin process development of small volume fill and finish with the equipment they plan to use at clinical scale. The collaboration with BioSpherix further enhances our current technology enabling it to operate within a fully closed environment along with the ability to control temperatures to limit risks during cryopreservation.”
Sexton and BioSpherix recognized each other’s capabilities as complimentary and that together, they could address a gap in process capabilities. Sexton’s rapidly deployable Fill and Seal system, AF-500, is capable of filling and sealing up to 500 CellSeal vials in 90 minutes and is available for immediate delivery and can be installed for use within a biosafety cabinet while the BioSpherix modular isolator is under construction. The BioSpherix modular isolator can be configured for any manual or automated, large or small, simple or complex bioprocess, making it the perfect fit with Sexton’s AF-500 to bring flexibility, sterility, and automation to our customers.
About Sexton Biotechnologies
Sexton Biotechnologies is a revenue stage, biotechnology company focused on the development and sales of bioproduction tools for cell and gene therapy founded in 2019 as a spin-out of Cook Regentec, a life science incubator/accelerator located in Indianapolis, IN. Sexton develops purpose-built CGT tools and media to enable flexible automation and scaling of cell manufacturing processes to increase the probability of positive clinical outcomes and reduce time-to-market, failure points, and labor costs. Sexton’s portfolio includes the CellSeal platform of cryo-storage tools and fill/finish systems and human platelet lysate growth supplements. More information at www.sextonbiotechnologies.com.
BioSpherix Ltd. is a New York based corporation focused for over 20 years on the design and manufacture of Cytocentric Cell Incubation and Processing Systems®, a unique equipment platform that controls critical cell process parameters at physiologic levels better than conventional equipment or any alternative, and enables antibiotic-free aseptic cell processing without chemical microbial biocides. The BioSpherix Medical division is the exclusive supplier of the only Cytocentric® isolator called the Xvivo System model X2, used by cell and gene therapy developers all over the world to produce the most potent cells. Extreme modularity enables it to close any cell production process, retains unlimited flexibility, and accelerates every phase of development at a fraction of the cost of traditional cleanroom suites. Designed to bring GMP to clinics, but just as capable in industrial pharmaceutical factories, including upstream in biotech. More information at www.biospherixmedical.com.