Major Milestone Will Speed Regulatory Filings for Recombinant Protein Therapeutics and Monoclonal Antibodies Developed with the Proprietary Selexis SURE CHO-M Cell Line
Geneva, Switzerland (PRNEWSWIRE) March 23, 2011 – Selexis SA, a Swiss-based biotechnology company with technologies for the rapid development and engineering of high yield and stable mammalian cell lines for therapeutic protein manufacturing, announced today the Company has completed the sequencing of their proprietary Chinese hamster ovary (CHO) cell line, the Selexis SURECHO-M Cell Line™. The project was performed in collaboration with the Institute of Biotechnology at the University of Lausanne, the SIB Swiss Institute of Bioinformatics and the CHUV, Centre Hospitalier Universitaire Vaudois (Lausanne University Hospital).
CHO cells are the leading industry choice for mammalian production of recombinant biologic therapeutic drugs. Approximately 70% of all recombinant therapeutic proteins and monoclonal antibodies (MAbs) are produced in CHO cells. Sales of these drugs exceed $30 billion USD annually . The proprietary Selexis SURECHO-M Cell Line is a high-performance suspension and serum-free adapted CHO cell line derived from the CHO-K1 lineage. The data from the sequencing of the Selexis SURECHO-M Cell Line will be used to generate detailed characterization packages of production clones for filings with regulatory agencies such as the Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Additionally, the data will be used to engineer the cell line’s production capabilities in a predictable way.
“The Selexis SURECHO-M Cell Line genome data will be a valuable tool for helping our clients to improve their CMC documentation packages for regulatory filings with the FDA and EMA. In the near future, Selexis will be in a very strong position to utilize the data and genome sequence to engineer new CHO cell lines with defined specificities. More importantly, our engineered CHO cell lines will have enhanced expression capacity, especially for difficult to express recombinant proteins such as blood clot factors or fusion proteins, thus yielding therapeutics of higher quality,” said Igor Fisch, CEO, Selexis SA. “The sequencing of our proprietary Selexis SURECHO-M Cell Line was a major accomplishment and a priority for Selexis in the continued improvement of our SURE Technology Platform.”
Today, CHO cell lines used in the manufacturing of recombinant biologic therapeutics are from multiple origins and the variations between the CHO genomes are poorly understood. Additionally, the genetic characterization of genetically modified CHO cell lines producing recombinant protein drugs can still be quite challenging, especially when DNA amplification methods have been used to create the cell lines. Thus, regulatory agencies are increasingly looking towards more thorough filing packages. With the improvement of sequencing and genomics technologies, it is now possible to build a genomic map of particular manufacturing cell lines to finely characterize the genetic and production characteristics. Sequencing of the Selexis SURECHO-M Cell Line genome represents one of the first efforts to take genomic scale technology and apply it to industrial biologic manufacturing and regulatory activities.
Selexis and its academic collaborators will continue to work on the data analysis and genome assembly from this work. In addition to allowing more accurate manufacturing of therapeutics, this data will be used to advance the study of gene regulatory networks and expression in the Selexis SURECHO-M Cell Line as well as to improve the quantity and quality of its biologic production capabilities by cell and genome engineering.