Accelerating the development of cell and gene therapies from discovery to biomanufacturing
OXGENE, a WuXi Advanced Therapies (WuXi ATU) company, provides cell and gene therapy pioneers around the world with technologies, automation platforms and service solutions to advance their pre-clinical research and accelerate the timeline to GMP manufacture. WuXi ATU, a global contract testing and development manufacturing organisation (CTDMO), offers world class integrated GMP manufacturing and testing platforms to reduce the time to market, while maintaining high titres, high levels of quality assurance and full regulatory compliance. Together, our complete end-to-end solutions support pioneering companies to be first in the race to deliver breakthrough cell and gene therapies to the patients who need them.
NOVEL CAPSID AND PROMOTER DISCOVERY SERVICES
OXGENE’s considerable expertise in molecular biology, gene editing, bioinformatics and automation support the delivery of early stage research projects. These include discovery of novel AAV capsids to improve transduction efficiency and specificity, and the discovery of novel promoters, designed to custom specifications and optimised for cell-type specific transgene expression.
BEST IN CLASS TRANSIENT LENTIVIRAL AND AAV EXPRESSION PLATFORMS
Novel promoters and capsids are designed to integrate into OXGENE’s industry leading XLenti™ or XAAV™ plasmids. XLenti™ 3rd generation, self-inactivating (SIN) lentivirus packaging plasmids are optimised for increased translation efficiency and have low homology between expression cassettes for an improved safety profile. Our XLenti™ plasmid system outperforms other commercially available equivalents and can be customised to optimise expression of any gene of interest. OXGENE’s XAAV™ plasmids contain reconfigured Rep and Cap genes, where Cap is placed under the control of a strong CMV promoter, while Rep is expressed at a lower level via an EMCV internal ribosome entry site. This results in a higher viral titre, better per cell rAAV productivity and improved full:empty vector ratio. Both our XAAV™ and XLenti™ plasmids are now available for sale, license free, at research, GMP-like and GMP grade from WuXi ATU.
SCALABLE SOLUTIONS FOR LENTIVIRAL AND AAV MANUFACTURE
XLenti™ stable clonal packaging and producer cell lines offer easy scale up, reduced cost of goods and reduced process complexity. XLenti™ packaging and producer cell lines contain the same proven genetic system as the XLenti™ transient system, facilitating a smooth transition to this more scalable technology, and retaining all the optimisation benefits developed for the transient system.
OXGENE has also addressed the challenge of scalable AAV production with our proprietary Tetracycline-Enabled Self-Silencing Adenovirus (TESSA™) system. This represents a major paradigm shift in AAV manufacturing by simultaneously providing Adenovirus (Ad) helper functions and encoded AAV rep/cap in one TESSA vector, and the ITR-flanked gene of interest in another to enable scalable, plasmid and adenoviral contamination free manufacture of high quality, high titre AAV.
GMP MANUFACTURE AND TESTING
WuXi ATU’s viral vector manufacturing platforms combine optimised cell lines, OXGENE’s XLenti™ and XAAV™ plasmid systems and significant experience in process development and scale-up with industry-leading analytics. Our world class integrated GMP manufacturing and testing platforms for cell and gene therapies offer end to end quality oversight, in FDA, EMA and other global regulatory body compliant CGMP facilities. WuXi ATU’s platform approach improves yields and saves significant time in technology and material transfer and optimisation, reducing manufacturing costs and accelerating time to market. Our deep understanding of the global regulatory landscape is used to support customers through submission to accelerate the delivery of their breakthrough cell or gene therapies to the patients who need them.