Coldstream Laboratories Announces the Addition of a New Semi-Solid Filling Suite

Coldstream Laboratories Inc. has expanded its semi-solid manufacturing facilities with the addition of a new semi-solid filling suite.

• Controlled access suite features an IMA tube filler model #1090
• Designed to fill and seal flexible tubes with dense and semi-dense pharmaceutical, cosmetic and chemical products

Features:

• Tube fill volumes from 2 to 250 mL
• Validated to produce up to 4,200 tubes per hour
• Fills aluminum, laminate, polythene and polyfoil tubes
• Controlled environment to reduce particulates

Located in Lexington, Kentucky, Coldstream is a specialty manufacturer of drug products for the global pharmaceutical industry. We also specialize in the development and production of sterile injectible and topical drugs.
For more information visit www.coldstreamlabs.com or email customerservice@coldstreamlabs.com

Kentucky BioProcess collaborating in development of anti-rabies antibody with South African-based Council for Scientific and Industrial Research

Kentucky BioProcessing (KBP) has signed an agreement with the South African-based Council for Scientific and Industrial Research (CSIR) to develop a commercially efficient process for RabiVir,^TM—CSIR’s award-winning anti-rabies antibody developed in a start up venture with GreenPharm^TM.

The announcement follows GreenPharm^’s ^TM achievement in the Innovation Fund’s SA Bio Business Plan Competition* at the end of 2008. CSIR plant biotechnologists walked away with an investment indication of up to R15 million (approximately $2 million US) and an opportunity for further training in the USA.

The start-up venture holds tremendous potential for using plants (in particular tobacco) to generate proteins used in preventative post-exposure rabies treatment and other complex therapeutic proteins such as HIV antibodies at a competitive price. Before finalizing the partnership, representatives from CSIR toured KBP.

Contract research and development manager at CSIR Biosciences, Fanie Marais, says, “KBP is well respected for its expertise in producing clinical grade biotherapeutics in plants. It has world-class good manufacturing production compliant (cGMP) facilities and provides contract services for bench scale, pilot and manufacturing process development in this field. cGMP conditions are essential for the production of antibodies that will go into early phase of safety testing.

According to the agreement with the CSIR, KBP will assist in the development of a process for the purification and preparation of clinical grade monoclonal antibodies (i.e high purity antibodies suitable for use in clinical development). The technology will be transferred to the CSIR and as part of the technology transfer process, CSIR scientists will spend time at KBP for training in all stages of process development. The agreement with KBP will help us speed up the commercialization process of RabiVir^TM.

“We will also obtain the necessary documentation from KBP as prescribed by the USA Food and Drug Administration to enable registration of the antibodies with the regulatory authorities,” Marias said. “This development bodes well not only for the successful production and commercialisation of clinical batches of an anti-rabies antibody, which would be packaged as a post-exposure prophylaxis, but also for human capital development within South Africa.”

Biotechnology in Owensboro

Owensboro, KY has been the center of attention in the plant made pharmaceutical world.  Kentucky BioProcessing and the Sullivan University College of Pharmacy recently hosted a Plant Made Pharmaceutical symposium in Louisville and Owensboro.  The conference attracted over 75 participants from around the world how work in this developing field.  Take a look at a few news stories from TV stations in the area.

http://www.14wfie.com/global/story.asp?s=10740837

http://tristatehomepage.com/content/video/?cid=82171

http://www.news25.us/global/category.asp?c=164155&clipId=&topVideoCatNo=160919&topVideoCatNoB=164126&topVideoCatNoC=124443&topVideoCatNoD=111254&topVideoCatNoE=143820&clipId=3961783&topVideoCatNo=160919&autoStart=true

 

From my own personal experience, I have enjoyed watching the Owensboro biotech community grow.  Over the past three years, I have watched as a group of dedicated individuals have worked together to build an industry that will help attract high tech jobs to Kentucky.  The folks at Greater Owensboro Economic Development Corporation have down a great job championing this industry, along with Kentucky BioProcessing, Owensboro Medical Health Systems, and a variety of other players.  Below is a little more information on what they do.  If you would like to see this in person, please contact me.  I am putting together a trip for August 6.

Plant-Made Pharmaceuticals Conference to Attract from Across U.S.

Sullivan University College of Pharmacy and Kentucky BioProcessing, LLC (KBP) are collaborating efforts to promote a very specialized area of research on Plant-Made Pharmaceuticals (PMPs).

On July 15 – 16, these two organizations will join forces to host the Plant-Based Therapeutics Symposium, the first conference of its kind in the United States. This conference will address very specialized research development that contributes to humanity at large by promoting protein and peptide drugs obtained from plants.

The first day of the conference, in Louisville, consists of ambitious podium presentations, where researchers from more than ten states and two countries will share their findings on PMPs. The inaugural event occurs on Wednesday as well. This event will include two keynote speakers, Dr. Jeanne Novak of CBR International and Dr. Charles Arntzen of Arizona State University, presenting their scientific experience within the PMP field and industry. Novak, CBR International’s Principal Consultant and Chief Executive Officer and a well-known professional in the PMP world, will also serve as the Chair of the entire conference. The day’s presentations will fall into one of three categories: General Applications of Plant-Based Therapeutics, Plant-Based Antibodies/Anti-Cancer Agents and Plant-Based Antivirals.

Thursday is to be held at the KBP facilities in Owensboro. A tour of the facilities, along with presentations by key PMP industry professionals, will start the second day of the conference. Dr. Yuri Gleba, of Icon Genetics in Germany, will present how PMPs contribute to human health. That afternoon, Dr. Jeanne Novak and Dr. Kathy Hanley will lead an interactive workshop called “Quality Systems Development for Plant-Made Pharmaceuticals.”

This Plant Based Therapeutics Symposium will bring together some of the world’s leading experts to discuss potential product breakthroughs, different PMP production systems, and the business and regulatory issues unique to this emerging industry. Researchers of all levels, and students interested in the field, will share experiences and results from PMP-based research.

Plant-based therapeutics are part of a developing science that use natural proteins and peptides from living organisms, primarily plants, to produce remedies for various ailments. Utilizing such a plant-based transient, or transgenic gene expression system, significantly reduces the time, risk and huge capital expense of a typical bioreactor. This conference is planned to be the first of many in the years to come, as PMPs are expected to gain momentum and popularity within the United States.

This exciting event will begin at the Sullivan University College of Pharmacy facilities, located at 2100 Gardiner Lane in Louisville. Conference hosts will provide transportation from Louisville to Owensboro, and back, for the second day’s events at KBP. Educators, scientists and researchers are encouraged to attend, but the program is open to anyone who has an interest in furthering his or her knowledge of PMPs.

Interested participants of the conference should contact the Conference Secretary, Allison Koch, at (502) 413-8955 or akoch@sullivan.edu, or may find further information and details at http://www.sullivan.edu/pharmacy/conferences_symposiums.asp. Interested parties are encouraged to go online to for details.

The Biotechnology Industry in Kentucky

The Biotechnology Industry in Kentucky

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Kentucky BioAlliance hosts reception at BIO Conference

On May 20, the Kentucky BioAlliance hosted a reception at the BIO International Conference in Atlanta. More than 200 life science professionals turned out to hear about the exciting developments in Kentucky's life science sector.

Governor Steven L. Beshear continued a long tradition of participating in the annual conference. At the reception, Governor Beshear took the opportuntity to recognize the growth of Kentucky's high-tech sector and discussed the importance of focusing resources on new economy jobs. After speaking the the crowd, Governor Beshear walked around the room and talked one-on-one with the attendees.


This event was sponsored by:
Stites & Harbison
University of Kentucky
University of Louisville
Kentucky Seed Capital Fund
Commerce Lexington
Greater Louisville Inc.
Greater Owensboro Economic Development Corporation

Plant Based Pharmaceuticals

Kentucky BioProcessing and The Sullivan University School of Pharmacy are hosting a plant-based therapeutics symposium on July 15-16. For more information click here.

The symposium will take place in Louisville and Owensboro, home of Kentucky BioProcessing. Featured speakers include Dr. Charles Arntzen, co-director of the Center for Infections Diseases and Vaccinology, as well as Dr. Yuri Gleba, Managing Director, Icon Genetics.

If you are interested in attending, please contact Sullivan University.