Amunix Establishes GMP Manufacturing of XTEN® at UN-L BPDF
MOUNTAIN VIEW, CA–(Marketwired – Nov 16, 2015) – Amunix Operating Inc. (Amunix), a leader in the area of protein half-life extension, today announced that it has completed tech transfer and successful GMP (Good Manufacturing Practices) scale-up of Amunix’s XTEN® manufacturing process at the University of Nebraska-Lincoln Biological Process Development Facility (UNL-BPDF). XTEN is the brand name for Amunix’s protein-based, patented half-life extension technology. Process scale-up at UNL-BPDF was successfully completed in the second quarter of this year, enabling kilogram production of GMP grade XTEN using the highly efficient, fermentation-based XTEN processing platform developed at Amunix.
“The enablement of our platform XTEN process technology at GMP scale is a significant milestone for Amunix as we now have the ability to flexibly and efficiently engage in the cGMP production of internal and external pipeline products slated for clinical evaluation,” said Ulrich Ernst, Ph.D., SVP, technical operations at Amunix. “We commend the staff at The Biological Process Development Facility at UNL for working seamlessly with Amunix to ensure technical success and achieve this important advancement.”
Volker Schellenberger, Ph.D., president and CEO of Amunix, added, “The availability of scalable cGMP XTEN manufacturing provides Amunix and our development partners with another versatile tool to explore and evaluate clinically novel candidates that have been enhanced with Amunix’s patented XTEN half-life extension technology. It also sets the stage for accelerating our internal and external partnering development efforts.”
Wallace Buchholz, Ph.D., director of UNL-BPDF, said, “The collaboration with Amunix for the development and production of various XTEN and XTENylated products embodies our commitment to advancing novel therapeutics that address current healthcare challenges. We are looking forward to providing continuing support for Amunix-partnered programs and to leverage our experience and expertise in fermentation technology, scale-up, and clinical manufacturing.”
Amunix Operating Inc., based in Mountain View, CA, is a privately held biotechnology company focused on the discovery and development of novel therapeutics with improved in vivo half-lives. Amunix’s half-life extension technology is based on XTEN — hydrophilic, unstructured, biodegradable polypeptides that impart a number of favorable properties upon the molecules to which they are attached. XTEN can be recombinantly fused or chemically conjugated to peptides, proteins, and other pharmaceuticals. In addition to the advantages of reduced dosing frequency, XTENylation also stabilizes plasma drug concentrations, which often results in increased efficacy as well as reduced side effects. Two genetically fused XTENylated products, VRS-859 (exenatide-XTEN) and VRS-317 (human rrowth hormone-XTEN) have completed Phase 1 studies. Amunix partner Versartis successfully completed a Phase 2a clinical trial with VRS-317 and has initiated a Phase 3 trial in children with growth-hormone deficiency. Amunix is also working with other partners, including Eli Lilly, Biogen, Roche, Janssen, Baxalta, Ambrx, Zealand, Noxxon and other undisclosed partners in a wide range of therapeutic areas. Amunix is actively seeking partnerships for application of its XTEN technology. For additional information about the company, please visit www.amunix.com.
About University of Nebraska-Lincoln Biological Process Development Facility
The UNL-BPDF uses a synergistic multi-disciplinary approach to advance candidate vaccines and bio-therapeutics to Phase I/II clinical trials. BPDF fermentation processes are focused on optimizing and controlling high cell-density fermentations of Pichia pastoris, Saccharomyces cerevisiae, Escherichia coli, and other microbes for production of recombinant proteins. For over 19 years, the BPDF has provided customers with access to experienced biopharmaceutical process research & development scientists and engineers, process development capabilities, and GMP manufacturing facilities. The UNL-BPDF is equipped with a 6,000 ft2 modular GMP suite with a 150 L (working volume) bioreactor and downstream processing for both secreted and intracellular products. Facility utilities include a pure steam generator, a water-for-injection (WFI) condenser, a 1000 gal WFI storage tank, and ambient and hot WFI distribution loops. The BPDF Quality Assurance and Scientific staff have an average of >18 years of experience in their respective fields (range 7-30 years). For further information about contracting the services of the highly skilled and experienced professionals at the BPDF, please visit bpdf.unl.edu.
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