Monday, November 2, 2009

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
  • 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 or email

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 GreenPharmTM.

The announcement follows GreenPharms 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 RabiVirTM.

“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.”

Friday, July 17, 2009

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.


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.

Monday, June 22, 2009

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, or may find further information and details at Interested parties are encouraged to go online to for details.

The Biotechnology Industry in Kentucky

The Biotechnology Industry in Kentucky

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Tuesday, May 26, 2009

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

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Monday, May 18, 2009

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.

Kentucky BioAlliance Members to Present at BIO

Two Kentucky BioAlliance member companies are presenting at the BIO 2009 conference. Below is more information on the presentations. Stop by and learn a little more about the exciting work taking pace in Kentucky.

Wednesday, May 20 in booth 5924

11:00 AM
Reinventing Plant-based Drug Discovery to Unblock the Pharmaceutical Pipeline
John M. Littleton, MD, Ph.D., Chief Scientific Officer, Naprogenix, Inc.

The flow of synthetic drugs from conventional R & D is slowing, eroding investor confidence in the pharmaceutical and agrochemical industries. Leveraging the extraordinary diversity of bioactive metabolites from plants could reverse the trend, but current approaches to plant-based drug discovery are slow and expensive. Applying functional genomics technology to the production of biologically active metabolites by plants could facilitate the discovery and optimization of active compounds in plants, and may challenge synthetic chemistry as a source of novel molecules in the future.

11:30 AM
Self-assembled Nanoneedles for In Situ Measurement and Manipulation of Soft Biomaterials
Mehdi M Yazdanpanah, Ph.D., CEO, NaugaNeedles

A unique nano-fabrication technology has been developed for growing individual nanoneedles of silver-gallium at a selected location and orientation. These electrically conductive nanoneedles provide stiffness that is well-matched to the viscoelastic properties of complex fluids and biological materials. The technology is being integrated into platforms for combined electrochemical and viscoelastic probing of live cells and subcellular organelles within live cells. Specific progress towards this system includes recent demonstrations of using silver-gallium nanoneedle-tipped probes to (1) make precise AFM measurements of the rheological properties of polymeric liquids, and (2) puncture individual live cells and measure viscoelastic response.

National Cancer Institute Announces new SBIR/STTR Initiatives

At a meeting with the National Cancer Institute (NCI), I learned of a few initiatives that are focused on early-stage life science companies. It appears that the NCI, along with the National Institute of Health, are making efforts to make obtaining pre-investor money easier. This is even better for Kentucky companies, since the state will match both Phase I and Phase II investments.

The first step the NCI is taking is to create SBIR/STTR experts within their program managers. In the past, NCI had 50 program managers that would handle a variety of funding programs, from small grants to large research projects. Going forward, NCI will have 8 program managers that are focused solely on the SBIR/STTR programs. This should help streamline the process.

NCI is also implementing a new Bridge program to help ensure projects move smoothly from Phase II (research and R&D) to Phase III (commercialization). The new Bridge program will follow-on to Phase II grants and will award up to $1 million/year for up to 3 years. The award will be used to match any money the companies have raised. I did confirm that state dollars (including matching dollars) will count.

The NCI also mentioned that they are working on a number of programs using stimulus money. More on that as it develops.

BIO International Conference

I am attending the 2009 BIO International Conference in Atlanta. Although it appears that the conference attendance will be down this year, there are a number of biotech professionals walking around downtown. From the list of companies I have seen so far, the conference still promises to provide a lot of opportunity to interact with professionals from across the world.

As interesting news develops at the conference, I will keep the Kentucky BioAlliance members posted via this blog. If you are at the conference and have interesting news to report, please contact me at

Monday, February 23, 2009

Biotechnology Industry Turns Profitable

Bad economic news seems to fly in from every direction. However, it is not all doom and gloom in the biotech sector. Below is an excerpt from the Burrill Report:

Stock prices have tanked, financial markets have seized and companies are laying off staff and putting promising projects on ice. In the midst of all of this grim news it's easy to overlook an important milestone for the biotechnology industry. Peter Winter, editor of The Burrill Report, has been crunching the numbers and he says some 40 years after the industry began, it actually hit a major milestone in 2008 by turning profitable for the first time in its history. It's not all good news by any means, but we talk to Winter about this major milestone for the industry, what we should make of it, and the emerging world of the biotechnology haves and the biotechnology have-nots. Read More Here

Kentucky BioAlliance

We are introducing the Kentucky BioAlliance blog as a way to share important news and information with all Kentucky BioAlliance members. If you have a story you would like to contribute or topics you would like to see discussed, please feel free to contact me.