NanoImaging Services Opens New Operation to Provide Structural Characterization and Validation of Biopharmaceuticals

NanoImaging Services, Inc. has commenced operation of a new business providing high-resolution, three-dimensional transmission electron microscope (TEM) imaging services to manufacturers of large molecule biopharmaceuticals. The service provides fast, accurate structural characterization and validation of new drug compounds, targets and assays; promising improved speed and reduced risk at all phases of the drug development process, from discovery and characterization through approval and manufacturing. NanoImaging Services was founded by researchers from The Scripps Research Institute with financial support from FEI Company (Nasdaq:FEIC), a leading manufacturer of TEMs and other tools for nanotechnology. The start-up has also benefited significantly from early contracts with Merck & Co., one of the world's largest pharmaceutical manufacturers, including a project to characterize virus-like particles of human papilloma virus in support of the development of Merck's recently-introduced Gardasil® vaccine. "A picture is worth a thousand words; a three-dimensional model is priceless,” said Clint Potter, NanoImaging’s president and CEO. "The ability to directly visualize biomolecular structures helps scientists and researchers make better choices, earlier and more often, and gives regulators increased confidence in their interpretation of complex analytical and clinical data.” Potter adds, "We can see important applications for this technology at almost every point in the development pipeline. In the end, it will help pharmaceutical manufacturers bring new, safer, more effective products to market faster, with lower, more predictable development costs.” "Although this technology is well-proven in the laboratory, we are the first to offer it as a commercial service, with tightly-controlled processes designed to deliver timely, high-quality results,” added Bridget Carragher, NanoImaging’s COO. "We come from the academic world, where we have worked extensively with commercial entities, and we understand the frustration clients can feel over the vagaries of research agreements, changing personnel, loosely-controlled protocols and intellectual property issues. We started NanoImaging Services to address those concerns by providing world-class technical expertise through a professional, business-oriented service operation.” "Ultimately all pharmaceuticals interact with living systems at the molecular level,” said Matthew Harris, vice president and general manager for FEI’s NanoBiology division. "Three-dimensional visualization of these structures will certainly play an increasingly important role in all phases of drug discovery, development and manufacturing. We are thrilled to be able to support NanoImaging Services in its efforts to make the practical benefits of this technology available to the pharmaceutical industry.” NanoImaging offers a variety of services, from visual inspection and statistical characterization to sophisticated 3D reconstruction and antibody/labeling experiments, using TEM procedures that range from conventional negative staining to advanced cryo techniques with automated image acquisition and analysis. In the most advanced applications, samples in physiologic solution are instantly frozen in vitreous ice to preserve delicate biological structures in their native hydrated state. Thousands of images, automatically acquired with low dose techniques, are sorted and averaged together to create high-contrast, high-resolution (approaching 1nm), low-noise images, and statistically valid sampling devoid of operator bias. A secure web-based interface allows clients to view images and direct experiments remotely, in real time. Results, along with all meta data, are stored in a relational database, preserving the provenance of all images for documentary purposes and providing a basis for long-term studies. Potter and Carragher, NanoImaging’s founders, both hold faculty appointments at The Scripps Research Institute in La Jolla, California, where they jointly manage the Automated Molecular Imaging research group. They have published extensively on TEM technology and the science it enables. NanoImaging Services, Inc. is located at 4045 Sorrento Valley Blvd., San Diego, CA 92121, USA. For more information, please visit www.nanoimagingservices.com. Editor Background NanoImaging Services, Inc. provides transmission electron microscope imaging services to the pharmaceutical, biotechnology and nanotechnology industries, and specializes in the characterization of large biological molecules used in biopharmaceuticals such as vaccines, antibodies, cytokines, hormones and gene therapies. In contrast to conventional (small molecule) drugs, biopharmaceuticals are typically protein-based and manufactured in controlled, modified, biological systems. Their complexity and similarity to naturally occurring compounds makes a detailed understanding of their structure, and its relationship to their safety and efficacy, essential in their development and approval. Biopharmaceuticals represent an important and rapidly-growing segment of the pharmaceutical industry. For more information, visit www.nanoimagingservices.com.