Miltenyi Biotec acquires lentiviral vector manufacturing business of Lentigen
Miltenyi Biotec is currently developing several alternative technologies for genetic modification of cells intended for application in clinical research. With the addition of Maryland-based Lentigen Technology’s capabilities, Miltenyi Biotec will broaden its cGMP (current good manufacturing practice) manufacturing capabilities and IP (intellectual property) in cell transduction.
Lentigen Technology, currently produces preclinical (non-GMP) and clinical (GMP) lentiviral vectors at its headquarters in Gaithersburg, Maryland, in a new 5000 sq. ft. GMP manufacturing facility, which consists of two parallel ISO 7 (Class 10,000) Suites and one ISO 8 (Class 100,000) Suite. The suites meet US FDA and EMA regulatory requirements, and are designed for production of clinical grade lentiviral vectors for Phase I and Phase II clinical trials.
“It is our goal at Miltenyi Biotec to become the major supplier of lentiviral vectors for cell and gene therapies, both for clinical research and at commercial scale,” CEO of Miltenyi Stefan Miltenyi said. “With the acquisition of the Lentigen assets, we have strengthened our comprehensive portfolio that will enable our current and future partners to proceed in cell therapies efficiently from preclinical testing through human studies to automated manufacturing for widespread commercial therapeutic use, all with a single strategic partner.”
Lentiviral technology provides for an efficient way to deliver genetic material into cells to modulate their function, which was demonstrated in recent clinical trials in genetic diseases and oncology indications utilizing lentivirus-modified chimeric antigen receptor (CAR) T cells.
Concurrent with the transaction, the sellers, now operating as Opus Bio, Inc., have been granted certain rights to deploy lentiviral technology in some therapeutic indications, for which Lentigen Technology, Inc. shall be the preferred manufacturing supplier.
In 2012, Miltenyi Biotech also launched a flexible instrument platform, called the CliniMACS Prodigy, which provides a tool for automated cell processing of cell and gene therapy products in a closed environment. The platform can handle all current technical requirements for manufacturing of cellular products by automation of the complete process.
The company also provides clients with all key reagents, media, buffers and plastic consumables required to set up customized manufacturing protocols on the CliniMACS Prodigy.
“Our goal is to become the major supplier of lentiviral vectors for cell and gene therapy, both for clinical research and at commercial scale,” the company told us. “A number of major companies and prominent clinical investigators have already expressed interest in collaborating with Miltenyi Biotec on multiple projects.”