Tuesday, April 15th, 2008

Sent by: Benchmark Biolabs

Another Industry First Enabled by Benchmark Biolabs - Peros’ Oral Delivery Platform and Vaccine Facility Licensed by the USDA

 April 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 Biolabs is a biopharmaceutical product development firm with over a decade of success in the validation and development of biologicals. Benchmark applies a unique mindset to the development process, offering a modern business strategy aimed at integrating the entire process, from Concept to Commercialization.
 
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
Benchmark Biolabs, Inc
Phone: (402) 475-8104
Email: toverbay@benchmarkbiolabs.com

Tuesday, April 8th, 2008

Sent by: Benchmark Biolabs

PerOs Obtains USDA Establishment and Product Licenses for it’s oral vaccine formulations

April 8^th 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 is a U.S.-based biotechnology company that has developed unique formulation methods enabling oral delivery of biopharmaceutical compounds by using naturally occurring products to create a technology platform to break the barrier of bioavailability for oral delivery of complex bioactive compounds.

PerOs, Breaking the barriers of bioavailability

For more informations

Jean-Simon Venne
PerOs Inc.
Phone: (514) 516-3003
Email: jsvenne@perosbio.com

 

Tom Overbay,DVM

Benchmark Biolabs, Inc

Phone: (402) 475-8104

Email: toverbay@benchmarkbiolabs.com

Tuesday, September 11th, 2007

Sent by: Benchmark Biolabs

Watch Our New Corporate Video Online

Benchmark Biolabs proudly presents our new corporate video!

This animation film presents the unique expertise of Benchmark in moving life science assets toward commercialization.

Just click on the link below to play the video.

http://www.benchmarkbiolabs.com/flash.html

Monday, October 30th, 2006

Sent by: Benchmark Biolabs

Avian influenza vaccine efficacy trials to begin late November

Imugene Limited has finalised arrangements to commence the efficacy trials for its new avian influenza vaccine candidates. The initial trial in poultry will be undertaken by Benchmark Biolabs Inc at its state of the art high level containment animal trial facilities in the United States.


The trial is scheduled to commence by the end of November 2006 with expected completion during January 2007. Results should be available shortly thereafter. Benchmark Biolabs is a specialist contract research provider with clinical trial facilities located in the US Midwest. The Nebraska clinical facility is an approved Animal and Laboratory Biosafety Level 3 (BSL-3) laboratory and trial facility making it one of the few locations worldwide that can undertake animal trials with infectious agents such as avian influenza.


The trial will determine the ability of the vaccine candidates to protect chickens against infection with the deadly bird flu virus. Imugene Managing Director, Dr Warwick Lamb said, “We have evaluated a number of potential trial facilities around the world and have chosen Benchmark Biolabs because of its commercial approach and expertise. Recently Imugene moved into our own laboratories and successfully completed the construction of the avian influenza vaccine candidates.” “To ensure our trials are conducted precisely to trial parameters and reliable timelines Imugene has moved the trial site to Benchmark Biolabs. This will add momentum and lead to greater international recognition of the trial result.”


About the Imugene avian influenza vaccines

Imugene has developed two different avian influenza vaccines for poultry. One is for the broiler (chicken meat) market and the other is for the breeder and egg layer markets. The trial vaccines both utilise Imugene’s proven Fowl Adenoviral Delivery Vector technology to deliver the necessary genetic material to stimulate a bird’s immune system to protect against the bird flu virus.

The two vaccine candidates differ as the commercial requirements for broilers and breeders or layers vary. The primary aim for a commercial bird flu vaccine for broilers is to provide immunity early in a bird’s life but the protection need only be short term as broiler birds typically reach market weight by 42-49 days of age. Layer birds and birds used for breeding stock for the broiler market require longer lasting immunity.

The vaccine designed for layers and breeders uses two antigens (rather than the single antigen used in the broiler vaccine) to elicit both antibody and cell mediated immunity. The vaccine candidates have been thoroughly verified by a series of in-house and external tests.

Major advantages of the Imugene vaccine candidates

An effective vaccine could be used to protect the world’s poultry industry from further avian influenza outbreaks and halt the spread towards Australia, Europe and the US. A viable vaccine to control outbreaks must be safe, effective and able to be quickly and easily administered on a large scale.The Imugene vaccine candidates use technology that allows authorities to differentiate between infected and vaccinated birds, a vital consideration for the international poultry industry. The vaccine candidates deliver only a portion of the flu genetic material instead of the whole virus. This makes the Imugene vaccines safe by preventing mutations or recombination with human flu viruses. The vaccine candidates generated using the Imugene delivery system are very cost effective for mass administration to entire poultry sheds and do not require injection of each bird.The vaccine candidates are specific to the H5N1 strain of avian influenza, but can be easily and quickly adapted to protect against other strains of influenza. The advantages of the Imugene vaccine solve the limitations of existing vaccines and treatments.

About Benchmark Biolabs

Benchmark Biolabs Inc, based in Lincoln, Nebraska, is a privately held contract service provider serving the life science industry. Benchmark’s customers include traditional and non-traditional biologics firms seeking technology development in a compliant environment. Benchmark has developed particular capabilities for the application of creative scientific solutions to address product development needs along a defined regulatory pathway for conventional and novel technologies. Benchmark Biolabs provides support to the animal health and life sciences industries by offering contracted services in the areas of laboratory services, clinical and pre-clinical studies, regulatory services and compliance, and small-scale manufacturing. Benchmark also provides business development and general management services to those clients in emerging businesses. Benchmark’s staff of scientists and professionals has an outstanding track record for bringing leading edge technologies from concept to the laboratory to the marketplace. The National Center for Import and Export (NCIE) has approved Benchmark’s Nebraska clinical facility to the required Animal and Laboratory Biosafety Level 3 (BSL-3) status. NCIE requires BSL-3 status for research involving certain infectious agents, including avian influenza. For procedures involving manipulation of infectious materials scientists conduct procedures within biological safety cabinets or other containment devices. Personnel wear protective clothing and equipment, and the laboratory includes special engineering and design features to ensure micro organisms are contained within the facility. According to Dr Tom Overbay, Director, Business Development, “The BSL-3 approval recognises Benchmark has the facilities, personnel and procedures to work safely with and contain pathogenic agents.” There are very few BSL-3 approved facilities within North America, a deficit which has impeded research efforts aimed at addressing important infectious disease threats, including avian influenza.

About Imugene

Imugene specializes in commercialising animal health products for production animals including pigs and poultry. Imugene owns the worldwide rights to the Fowl Adenoviral Vector Delivery System for poultry and the Porcine Adenoviral Vector Delivery System for pigs. Imugene has successfully licensed the first product based on the Fowl Adenoviral Vector Delivery System – the Poultry Productivity Enhancer. Imugene's poultry and pig portfolio is targeting a worldwide US$3 billion annual market with four lead vaccine products under development and a strong product pipeline. Consumer demands for disease free and residue free food will bolster Imugene's prospects. Imugene's products safely prevent disease and reduce or eliminate antibiotics and harmful chemicals in animals. Animal antibiotics and chemicals in the human food chain have been linked to the emergence of dangerous resistant bacteria in people and food residues.

For more information please visit the Imugene Website www.imugene.com

Wednesday, May 10th, 2006

Sent by: Benchmark Biolabs

Benchmark Biolabs breaking new ground with plant-based vaccine

Benchmark Biolabs is at the vanguard of developing animal health vaccines from plant cells.

Benchmark Biolabs is working with Dow AgroSciences on the breakthrough technology for the past five years. Dow AgroSciences is a wholly owned subsidiary of Dow Chemical Co.

The corporate giant recently announced it received the world’s first regulatory approval for a plant-made vaccine from the U.S. Department of Agriculture’s Veterinary Biologics. Most animal health vaccines are made from bacteria or animal tissue culture.

“With this achievement Dow AgroSciences is revolutionizing the field of preventive medicine with plant-cell-produced vaccines,” said Dow AgroSciences’ global business leader for animal health, in a news release.

Benchmark Biolabs developed the laboratory, testing and manufacturing methods used in making of the plant vaccine, said Tim Miller, the firm’s president.

Benchmark Biolabs plans to start manufacturing plant-based vaccines in a 21,000-square-foot building next to its offices in west Lincoln soon. USDA regulations require vaccine materials be developed and produced at the manufacturing site.

The Benchmark Biolabs in-depth knowledge was one of the main reasons Dow AgroSciences approached Benchmark Biolabs to help it develop the technology that, eventually, could be used to cure human diseases. But now the focus is developing vaccines for animals like horses, dogs and cats, poultry, swine and cattle.

Why use plant cells?

Miller explained a plant’s genetic material is stable and has a long shelf life, and is versatile to formulation.

Also, plant cells are more conducive to having things added to them to make other types of vaccines. In addition, there are no infectious components in a plant-based vaccine; and there’s no need to test for extraneous viruses.

“A plant does a wonderful job of synthesizing and producing the protein (used in the making of a vaccine),” Miller said.

No whole plants or greenhouses are used. Instead, Benchmark Biolabs grows cells using a process that begins with a single cell. Currently, Dow Agrosciences is experimenting with plants cells from tobacco, rice and corn.

“The one we licensed is made from tobacco (plant) cells,” Miller said. Those cells do not contain nicotine, he added.

Dow AgroSciences and Benchmark Biolabs developed a plant-based vaccine for Newcastle disease, a contagious and fatal viral disease affecting poultry. That is the vaccine that was submitted to federal approval.

Researchers chose Newcastle disease because it was ideal for demonstrating a new technology. Miller said there were many good vaccines on the market already and they all worked well. He said Newcastle disease was chosen for its scientific and regulatory value — not its commercial potential.

Basically, researchers took a gene out of the infectious component of the disease and transferred it into a plant cell, which uses the gene as its own. Large batches of plant cells were created through a fermentation process and proteins containing the anti-viral agent were later harvested.

“After that it’s a simple process of breaking the cells open,” Miller said, and using the viral protein as the vaccine.

The companies plan to produce various multiple types of proteins which could be used to develop vaccines for other diseases like West Nile, avian flu and diabetes.