The gene and protein expression services firm ATUM – formerly known as DNA2.0 – has been granted four patents by the US Patent and Trademark Office (USTPO) for its Leap-In transposase technology, turning its research tool into a cell line development platform.
“Protein pharmaceuticals is a rapidly increasing segment, requiring quick and efficient scale-up to accommodate not only new drugs coming to market, but also many biosimilars and biobetters,” the firm’s co-founder Claes Gustafsson told Biopharma-Reporter.
“Speed, yield, and product quality are critical factors for this market, and these are elements where we see an opportunity to grow based on proprietary Leap-In transposon technology.”
“A transposon is a genetic element that can jump from place to place on the chromosome using an enzyme called transposase. ATUM has engineered two of these transposases to be more efficient –i.e., to jump faster – making more copies while still retaining the genes in the transposon in unscrambled order,” Gustafsson explained.
By genetically separating the transposon from the transposase, he said the Leap-In tech can stop the element from jumping by removing the transposase.
“This is where speed and volume come in – we can increase production yield of any genes that are located in the transposon, and when we remove the transposase, the gene remains stably integrated on the chromosome. Having two orthogonal transposases opens a variety of cell engineering approaches to facilitate cell line development in a preferred genetic background.”
To support the move into cell line development, ATUM is constructing a 7,000 sq ft mammalian cell engineering laboratory at its Newark, California headquarters which will be staffed by 10-20 people once fully operational.
“The new facility will address two critical, rate limiting steps in biopharmaceutical drug development, manufacturing mammalian cell line development and cGMP cell bank manufacturing,” Gustafsson told us.
“The facility will be equipped with cutting edge instrumentation to facilitate throughput and assure compliance with the regulatory requirements associated with both processes. The exact instruments are currently being negotiated and will be available upon move-in.”
The firm is hoping for cGMP validation by the end of the year.