News ArchiveAnother Industry First Enabled by Benchmark Biolabs - Peros’ Oral Delivery Platform and Vaccine Facility Licensed by the USDAApril 15th 2008 Lincoln, NE. - The acceptance of Peros’ oral delivery platform and vaccine facility by the USDA marks another significant achievement by Benchmark Biolabs, a full service biopharmaceutical product development firm. Benchmark Biolabs designed, constructed and oversees the operation and management of the Peros production facility which is co-located on Benchmark’s R&D and manufacturing biotechnology campus in Lincoln, NE. By obtaining approval by the USDA, Peros, a pioneering biotechnology company that has developed unique natural product formulation methods enabling oral delivery of biopharmaceutical compounds, is now well positioned to begin product commercialization of its oral delivery platform. “Had it not been for Benchmark’s stage-gated “BEAM™” approach to our project from validation to licensure, our technology would have been yet another promising biotech discovery that would never have reached its commercial potential.”, stated Dr. Grant Vandenberg, CSO and Founder of Peros. Benchmark and Peros are excited to offer this first-in-class oral delivery technology platform that will significantly enhance the actual value of vaccines. The licensed platform offers a labor minimizing, practical method for oral delivery of prophylactic and therapeutic products for the livestock industry as well as traditional animal health company opportunities to expand the oral enablement of the industry as a whole. “Benchmark's mission is to design and implement, with our clients, an efficient product development process - delivering critical expertise, technologies, facilities, ideas and services, in a seamless and integrated offering”, added. Tom Overbay, Vice-President of Business Development for Benchmark Biolabs. Peros’ licensure marks another significant and innovative first obtained by Benchmark over their 11-year history. At the Benchmark campus there are now three licensed manufacturing facilities which were designed, built, and managed using the BEAM™ model for enabling biotechnology in stage-gated manner. Each of these facilities sprang from a novel, unique technology which was heavily reliant on the development process offered by Benchmark. Along with development of traditional biologicals, Benchmark has been intimately involved with molecular farming to produce a parasite vaccine and commercial development of a tissue culture based plant-derived recombinant protein production system. “Enabling technology is not specific to the nature of an asset but rather to the focused and prioritized implementation of key regulatory steps toward commercialization. In addition to the routine business at Benchmark Biolabs, we have initiated the setup and operation of five separate biotech institutions covering a wide array of biotechniques, molecules, and regulatory compliance. That is a new company nearly every 2 years since the inception of Benchmark Biolabs and demonstrates the business niche of enabling bio-molecules rather than simply discovering them.” said Tim Miller, President of Benchmark Biolabs. About Benchmark Benchmark's team provides analytical, clinical, (including a BSL-3) custom laboratory, regulatory process development, manufacturing and QC services in order to enhance the optimal data sets and efficiency of product development for our clients. For more information Tom Overbay, DVM PerOs Obtains USDA Establishment and Product Licenses for it’s oral vaccine formulationsApril 8th 2008 The PerOs team is proud to announce the USDA/CVB has granted PerOs an Establishment License for the production of bacterins as well as an autogenous bacterin license utilizing its patented oral delivery formulation methods (Oralject). "The approval of our manufacturing facility and our oral vaccine formulation platform in the United States marks a significant milestone for our Company, and we look forward offering these capabilities to the livestock producers and opening new possibilities to the growing aquaculture market, as well as collaborating with traditional animal health companies to expand the oral enablement of the industry as a whole." said Grant Vandenberg, CSO and inventor of Oralject. PerOs’ oral delivery platform focuses on the use of natural products to provide delivery of safe therapeutic and prophylactic compounds. PerOs’ formulations are designed to enable the delivery of biological compounds such as vaccines, peptides, and probiotics among others while eliminating the stress associated with handling, injection and other current delivery practices. This new technology platform will enhance the value of vaccines by offering a labor-minimizing, practical oral delivery approach for the livestock industry and open up new possibilities to the rapidly growing aquaculture market. Oral vaccination will provide animal producers with an innovative tool for disease prevention through vaccination rather than relying on disease treatment using antibiotics. PerOs’ is excited to offer this unique tool to an industry focused on producing safe, healthy food for humans. “Oral delivery will improve the adoption of vaccine usage. Vaccination can now occur when appropriate for disease management rather than based on labor management.” said Tom Overbay, Vice President Business Development. PerOs’ first-of-its-kind facility was made possible by the contribution of Benchmark Biolabs development team. Benchmark managed the regulatory interface and established the QA and QC standards while also designing, constructing and, today, operating the PerOs manufacturing facility. "The work of the Benchmark team was perfect, using their BEAM process flow, they led our technology assets in record time toward regulatory approval.” said Ian Kott, Chairman of the Board of PerOs. About PerOs PerOs, Breaking the barriers of bioavailability For more information Jean-Simon Venne Tom Overbay,DVM |
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