BioLife Solutions, Inc., a leading supplier of class-defining bioproduction tools and services for the cell and gene therapy and broader biopharma markets, announced an extended collaboration with Seattle Children’s Therapeutics, a venture at Seattle Children’s, bringing cutting edge, curative technologies and therapies to defeat pediatric cancer and other diseases that impact children. The collaboration will focus on establishing best practices in biopreservation and closed-system manufacturing with the introduction and integration of Sexton’s AF-500™ for closed-system processing for cell therapy manufacturing and viral vector delivery that will be used in Seattle Children’s Therapeutics new lentiviral vector manufacturing facility called VectorWorks.
“This expanded collaboration is an exciting step for Seattle Children’s Therapeutics as we work towards developing closed-system processes for cell therapy manufacturing,” said Matt Selley, Director of GMP Manufacturing at Seattle Children’s. “Lentiviral vector manufacturing is a critical component of the cell production process.”
Seattle Children’s has utilized BioLife’s CryoStor cGMP freeze media for several years, as an optimized excipient for improved post-thaw viability and functional recovery of cells used in clinical applications and trials. As cell and gene therapy manufacturers move toward closed-system processing, it is vital that upstream critical excipients and ancillary materials, such as viral vectors, are manufactured and packaged in containers suitable for closed-system integration. While some upstream bioprocesses have been successfully automated, the final steps of downstream bioprocess, namely fill-finish, are often performed manually in open systems with associated risks of contamination and user error. Furthermore, current packaging for viral vector intermediates demands that therapy developers operate in higher grade environments due to the open nature of this manufacturing step.
This continued collaboration will combine the Sexton off-the-shelf automated fill-finish system, AF-500, with Seattle Children’s Therapeutics’ expertise in viral vector manufacturing. Sexton’s rapidly deployable AF-500 is capable of filling and sealing up to 560 CellSeal® vials in 90 minutes. The goal is to utilize the AF-500 to initiate high throughput fill-finish of vector intermediates. Vectors will be filled into Sexton’s proprietary vials, CellSeal and CellSeal Connect™. CellSeal Connect builds on the original CellSeal cryogenic storage vial, which has been incorporated as the final drug packaging in commercial cell therapy products. The new version allows closed-system retrieval of intermediate products, such as viral vectors, thereby negating the need for therapy developers to operate in higher grade manufacturing suites for delivery of vectors and cargo.