Mediomics, LLC Receives Phase II SBIR Contract: Awarded $997,251 to Develop New In-Process Analyzer for Biologics

PRESS RELEASE
ST. LOUIS, October, 2012

Mediomics, LLC has been awarded a $997,251 Phase II SBIR contract (HHSN261201200081C) from the National Cancer Institute, National Institutes of Health, Department of Health and Human Services. This project builds on successful Phase I research, and aims to develop a fully automated in-process analyzer to monitor the titer and quality of recombinant biologics. Using Mediomics’ innovative molecular PINCER® platform, Phase II work will include development of more quantitative antigen-specific assays for antibody titer, affinity, glycosylation and aggregation. This project will culminate with beta-testing by Gallus Biopharmaceuticals, a leading cGMP biologics contract manufacturing organization.

Mediomics is currently focused on developing a sustainable, profitable biotechnology business that provides innovative assay kits, biosensors and microarrays for academic and corporate medical and environmental research, point of care testing, and food and pharmaceutical production process control.  These assay kits will be used to quantify most biologically and therapeutically important macromolecules, including ligands, proteins, protein complexes, and pathogens, including bacteria, fungi and viruses.  By 2012, it has been estimated that the global market for biosensors will reach approximately $6.1 billion dollars.

The company’s rapid, mix-and–measure homogeneous assays have already been adapted for the detection of a range of important macromolecules, including cAMP, tryptophan, S-adenosyl methionine, PDE, biotin, insulin, C-peptide, albumin, C-reactive protein (hCRP), IgG, IgM, E. Coli,  and others.

Mediomics collaborates with leading partners in industry and academia to develop applications for its PINCER® platform. Dr. Daren Chen, Professor of Engineering at Washington University in St. Louis, will continue to collaborate with Mediomics on design of a stand-alone detection instrument. Gallus Biopharmaceuticals will assist with testing Mediomics’s new PINCER®-based homogeneous assay system to measure antibody quality. As a preferred CMO provider to Mediomics, Gallus stands ready to assist customers looking for expertise using the technology to expedite new product development.

“The grant will be extremely helpful to move this cheaper, faster screening technology into mainstream applications,” said Mediomics President, Dr. Yie-Hwa Chang. “We expect the availability of the molecular PINCER®-based automated in-process analyzer will displace cumbersome benchtop instruments and gain acceptance for use in biologics production and food pathogen detection.”

About Mediomics LLC: Dr. Yie-Hwa Chang founded the Company in August 2001.  The Company is commercializing core technologies for which it has secured an exclusive license from Saint Louis University, including the following: (i) Bridge-It®, a DNA-binding protein-based bioassay platform, (ii) a related variant – the molecular PINCER®-based homogeneous biosensor and bioassay platforms and companion devices, and (iii) innovative, proprietary methods to screen and develop new high-affinity capture reagents for research, diagnostic and therapeutic use. For additional information, visit the website at www.mediomics.com, or contact Margaret Meng, Chief Administrative Officer, by phone at (314) 971-3028.

About Gallus Biopharmaceuticals: Gallus BioPharmaceuticals is a leading cGMP biologics contract manufacturing company offering exceptional contract services to its clients. The firm, based in St. Louis, MO was established in 2010 and acquired a world-class commercial biopharmaceutical manufacturing facility and workforce from  the  Johnson & Johnson/Centocor division in 2011. In addition to process development and clinical  supply  services,  Gallus  currently  produces  two  commercial  products, Remicade® and Stelera™,  which  are distributed globally.  The St. Louis facility has been approved by every major regulatory body worldwide.    For additional information on biopharmaceutical contract development and manufacturing services, visit www.gallusbiopharma.com, email [email protected], or call directly at (314) 426 – 5000.