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Monthly Archives: February 2012

This is a guest post from the BiotechBlog Intern,  Fintan Burke. Fintan is a student at the School of Biotechnology at Dublin City University. Do you have a response to Fintan’s post? Respond in the comments section below.

One of the most overlooked but consistent problems facing many governments is waste management. Despite healthy recycling attitudes in both the US and UK, an EPA report showed US total waste production in 2010 was still around 250 million tons, while there are concerns that the UK will run out of landfill sites by 2018.

For many years, the only viable alternative to landfills was incineration. Despite its efficiency over landfill sites (incineration can reduce the waste mass by around 90%), concerns over small energy generation efficiency (estimated at 20-25%) as well as public protest over environmental impact mean incineration can never be a permanent solution.

As public and private sectors are beginning to shift their attention to cleaner, more efficient alternatives to waste disposal, one of the leading candidates is gasification.

Gasification has been with us in various forms since the 1840s. The process involves extracting combustible gases by subjecting dehydrated carbonaceous materials to intense temperatures and reacting the resulting ‘char’ with oxygen and/or steam. Originally coal and wood were used in the process and so bore little difference to incineration. Since the 1970s, however, focus has shifted from using these conventional inputs to biomass.

From this change in focus, several companies have been set up to offer biomass gasification as an effective renewable resource. One such company, Thermoselect, claims that for every 100kg of waste processed, 890kg of “pure synthesis gas” is created for energy generation. Another company, ZeroPoint Clean Tech Inc., is keen to demonstrate gasification’s use in generating renewable gas, heat, water and electricity.

This development has been embraced by both the US and UK governments, welcoming the opportunity to reduce their carbon footprint as well as municipal waste. In April 2011, the US Air Force Special Operations Command invested in a new plasma-based transportable gasification system, with the aim of reducing its waste output by 4,200 tons a year in air bases across the country. Later that year, Britain approved the first advanced gasification plant in the country, with the potential to generate 49 megawatts of renewable energy (enough to power around 8,000-16,000 US households). Some have even speculated that this new technology could be used to spark a boom in hydrogen cell powered vehicles in the future.

Not everyone has embraced the new technique, however. The proposal for a biomass gasification plant in DeKalb County, Georgia was met with protests from locals, fearing carcinogenic emissions. Furthermore, a 2009 report by The Blue Ridge Environmental Defence League warned that gasification shares many similarities with incineration, including the formation of pollutants and greenhouse gasses.

Despite these arguments, the gasification of biomass has several benefits. The high temperatures make them an ideal means of processing bio-hazardous waste from hospitals and the plants themselves occupy very little physical space. As with any emerging technology, however, uptake is cautiously slow. Many of the new plants are in trial stages and it is uncertain whether gasification will have any long-term environmental effects. Should the existent plants prove to be successful, there is no reason to doubt that gasification will become a realistic solution for environmentally sound energy generation.

 

About the author:

Fintan Burke is a student at the School of Biotechnology at Dublin City University. His main fields of interest include biomedical therapies and recombinant organisms.  Fintan may be contacted at fintan.burke2@mail.dcu.ie .

The Journal oJournal of Commercial Biotechnologyf Commercial Biotechnology seeks applications for two volunteer Associate Editors. Posts are for renewable 1-2 year terms, with the potential to advance to Managing Editor.

Duties include soliciting submissions, working with authors to improve promising manuscripts, managing blinded peer-review, communicating with authors and reviewers, submitting editorials, and assisting the Chief Editor as required.

The ideal candidates will have an academic post and complement the Chief Editor by having a research focus in one of the following areas:

  • Management
  • Policy
  • Finance
  • Law
  • Regulation
  • Bioethics

Other desirable characteristics include:

  • Ability to solicit papers in geographic regions and commercial biotechnology topic areas which are currently under-represented in the JCB
  • Previous editorial/referee experience
  • Ability to meet deadlines and handle correspondence professionally
  • A record of publications in competitive and refereed journals

Application Instructions

Applications should be emailed to Chief Editor Yali Friedman at editor@CommercialBiotechnology.com no later than March 31st 2012 and should consist of:

  1. A cv
  2. A statement of purpose indicating both why you would like to become an Associate Editor, and later advance to Managing Editor, and your qualifications
  3. Copies of recent publications

About the JCB:

The Journal of Commercial Biotechnology is the definitive international quarterly publication for bioscience business professionals. Founded as the Journal of Biotechnology in Healthcare in 1994, the JCB has been published since 1998. The Journal is designed specifically for those professionals who need to enhance their knowledge of biotechnology business strategy and management, improve and advance their product development or want to keep up-to-date with the current issues and industry trends. Sample papers are available at http://commercialbiotechnology.com/pages/view/sample-papers .

This is a guest post from Erin M. Hall. Erin is the Technical Leader at Genetica DNA Laboratories, Inc. located in Cincinnati, OH. Do you have a response to Erin’s post? Respond in the comments section below.

It is estimated that 18-36% of all actively growing cell line cultures are misidentified and/or cross-contaminated with another cell line (1).  For researchers in any field of biomedical science, this could mean that a significant amount of the experimental data published in current and past journals is of questionable value.  Every year, millions of dollars of public money are spent on potentially wasted research and this is happening not just here in the United States but around the world as well.

Cell line misidentification and cross-contamination has been around for more than 50 years.  It was finally brought to light in 1966 by Stanley Gartler, who reported that 19 supposedly independent human cell lines were in fact HeLa cells(2), which are known to be extremely robust, fast growing and able to contaminate other cultures by aerosol droplets.  There was much resistance to his findings and scientists didn’t want to admit that the research done using those contaminated cell lines may be questionable and potentially irreproducible.  Walter Nelson-Rees was one scientist who supported Gartler’s findings.  Nelson-Rees highlighted the papers and the scientists who were publishing experimental data using misidentified cell lines and for this, in 1981, he lost his contract with the National Institutes of Health (NIH) because his behavior was deemed “unscientific”(3).  From 1981 and on, misidentification went unchecked and even cell line repositories continued to distribute lines under their false names (3).

To exacerbate the problem, certain cell culture practices may be aiding cell misidentification and cross-contamination, including the practice of assessing the phenotypic characteristics, such as protein expression, as the only way to properly identify the cell population.  It has been proven that phenotypic expression can change with an increased passage number or even with changes in growth medium or other cell culture conditions(4).  The modern way of assessing the correct identity of the cell line (“cell line authentication”) is to perform short tandem repeat (STR) DNA testing.  The STR DNA profile of a human cell line is similar to a person’s fingerprint; it is unique to that individual.  STR testing is now the “gold standard” of human identification testing and is routinely used by the FBI in profiling convicted offenders (CODIS).  STR profiling is a straightforward and effective way to confirm that the cell line you think you have been using for the past 5 years, is in fact, the genuine cell line.

The reason the problem continues today is because it has not been properly brought to the attention of researchers.  Many researchers learn about the service the hard way, i.e. at the last minute when the journal requests confirmation of authentication before considering your article for publication.  In a survey that profiled 483 researchers who actively use cell cultures, only 33% authenticate their cell lines and 35% obtained their lines from other laboratories rather than a cell line repository, such as American Type Culture Collection (ATCC) (3).  We, as researchers, expect to use only the best reagents and supplies but the one aspect of the experiment that may be the most important, i.e. the cell line, is consistently and explicitly overlooked.  ATCC recommends verifying the identity of all cell lines before you start your experiments, every two months during active growth, and just prior to publication.

The NIH now officially recognizes that cell line misidentification is a serious problem in the scientific community.  They state in a formal notice issued on their website (NOT-OD-08-017) that grant applications that fail to employ acceptable experimental practices would not be looked upon favorably and would potentially not fare well in the journal review process.  The NIH encourages all peer reviewers and researchers to consider this problem carefully “in order to protect and promote the validity of the science [they] support”.  Many journals, such as those published by the American Association for Cancer Research (AACR) require a statement in the “Materials and Methods” section as to whether cells used in the submitted manuscript were authenticated.  Not properly authenticating the lines may prohibit the article from being published when peer reviewed.   To continue the advancement towards the elimination of the problem of cell line misidentification and cross-contamination, ATCC, in early 2012, released a set of guidelines written by the international Standard Development Organization (SDO) workgroup; these guidelines provide researchers with information on the use of STR DNA profiling for the purpose of cell line authentication.  In the near future, with the help of all of these influential supporters, cell line authentication will become a routine quality control check in every laboratory in the United States and around the world.

I would love to hear other thoughts and comments on this topic.  Tell us about your experiences with cell line authentication – good or bad!

(1)   Editorial – Nature 457, 935-936 (2009).
(2)   Gartler, SM. Second Decennial Review Conference on Cell Tissue and Organ Culture: 167-195 (1967).
(3)   ATCC SDO Workgroup.  Cell line misidentification: the beginning of the end: 441- 448 (2010).
(4)   Kerrigan, L.  Authentication of human cell-based products: the role of a new consensus standard: 255-260 (2011).

About the author:

Erin is the Technical Leader at Genetica DNA Laboratories, Inc. located in Cincinnati, OH. She is responsible for the technical operations of the laboratory, as well as, all aspects of the daily casework involving DNA identity sample processing and quality assurance. She received her Master’s degree in Forensic Science from PACE University in NYC and her Bachelor’s degree in Molecular Biology from the College of Mount Saint Joseph in Cincinnati, OH. For more information on Genetica, visit www.genetica.com or their website dedicated to cell line authentication, www.celllineauthentication.com .

Prior to joining Genetica, Erin worked in New York City as a laboratory manager and researcher in the Pharmacology department at Cornell University’s Medical School. She designed and executed complex experiments that examined the effects of environmental toxins on liver enzyme production utilizing HPLC, UV/vis spectroscopy, Western blotting and PCR analysis. Her work contributed to several published journal papers (under Erin Labitzke, if you want to read them!), most recently including being cited as first author on a paper related to enzymes present in mitochondria.

Erin may be contacted at erinhall@genetica.com.

The Journal of Commercial Biotechnology is sponsoring the first International Bioentrepreneurship Education Conference.

The conference is be an opportunity to connect and begin to discuss best practices in bio-entrepreneurship education. Attendees will share global education programs currently being offered, and will identify any gaps in education today. The program will focus on academic, credit-bearing degrees and certificates.

The conference is sponsored by:

  • The Johns Hopkins Center for Biotechnology Education
  • The University of Colorado
  • The Journal of Commercial Biotechnology

The conference will be held at the Johns Hopkins University, Rockville, Maryland campus, which is located in the heart of the Maryland Biotechnology Industry, just outside of Washington, DC, and near the National Institutes of Health and the FDA, and will begin Friday evening, June 15 at 5pm and will end Saturday evening, June 16. This is just before the BIO annual meeting.

Conference Details

Attendees:Administrators and Educators in academic, credit-bearing bioentrepreneurship, bio-innovation, biotechnology enterprise
Date:June 15-June 16, 2012
Location:Johns Hopkins University Montgomery County Campus, Rockville, MD
Accomodations:Click here for a list of hotels near the Johns Hopkins University Montgomery County Center
Sponsors:Johns Hopkins Center for Biotechnology Education, Journal of Commercial Biotechnology, University of Colorado
Objectives:1. Determine present status of global bioentrepreneurship education programs
2. Identify possible gaps in BioE education programming
3. Identify partnership opportunities between schools and programs
4. Identify challenges and opportunities for BioE programming
5. Identify needed resources for BioE education—what do we have and what do we need?

The conference will not include research presentations. However, the Journal of Commercial Biotechnology will be publishing the proceedings. If you would like to submit a formal article regarding bioentrepreneurship education, please contact Arlen Meyers at Arlen.Meyers@ucdenver.edu

This is a guest post from the BiotechBlog Intern,  Fintan Burke. Fintan is a student at the School of Biotechnology at Dublin City University. Do you have a response to Fintan’s post? Respond in the comments section below.

According to a BDO industry report, a smallUS biotech company in 2010 enjoyed average revenues of around $42m while larger firms reported average revenue of around $124m. Additionally the European biotech sector also enjoyed a sizeable success with revenues totalling €13bn the same year. Global biotechnology revenues are estimated to grow to €103bn by 2013, bolstered by the pharmaceutical market which is expected to become a trillion-dollar industry by 2014.

These high revenues can attract more than just investors; smaller companies are seeing the benefits of asserting breach of their own patents in order to attain lawsuit settlements or licensing fees. Though more well-known in the technology sector, these ‘Patent Trolls’ have started to attract attention in biotech circles.

A standout case was that of Classen Immunotherapies Inc. which brought four biotechnology companies and a medical group to court for infringing on their patent of an immunisation schedule that could curb the risk of developing chronic diseases. Although the lawsuit was first thrown out by the district court as only a mental abstract, on appeal the federal court ruled in Classen’s favour citing that Classen has a “statutory process” that allows for patent protection.

This has set a troubling precedent in biotech law; since the Classen patents were somewhat broad, there could soon be a flood of similar companies trying to claim patent infringement based in immunisation or dosage schedules.

Indeed, there is proof of some small firms already trying to build a portfolio of biotech patents. These ’non-practicing entities’ deliberately gather patents – not in order to develop products – but rather extort other companies for settlements or licensing fees. There are already specialized law firms which help companies obtain and enforce biotech-specific patents. Such companies have been known to damage stock prices, delay production and eat into revenues – all of which is completely legal.

Many identify these frivolous litigations to lie not in the vagueness of the patents, but rather in unspecific patent legislation. In Ronald I. Eisenstein’s 2006 column in The Scientist, he notes that “One size does not fit all in terms of approaching patents.” Any legislation passed to curtail the practice of ‘Trolling’ in the technology sector may inadvertently harm smaller biotech companies and universities that rely on larger companies in the FDA approval process.

In his 2008 book Intellectual Property and Biotechnology: Biological Inventions, Dr. Matthew Rimmer offers some solutions to this growing problem. “Novelty and utility are the criteria used to judge whether something is inventive or not” he writes. “It is really those doctrinal concepts that need to be tightened.”

In a 2011 Forbes article Colleen Chien also offered some advice to defend against the trolls. She notes that many trolls will use contingent fee based lawyers to manage costs. Firms that pay via successful disposal of a suit or minimise settlement costs cn likewise minimise legal fees and increase the lawyer’s incentive to defend them. Furthermore, larger firms could be better off outsourcing their defence to specialist lawyers, rather than solely relying on their own legal team.

Patent trolls remain a very real problem in the world of technology. In the most infamous case, Research In Motion (producers of the Blackberry) paid a $600m settlement to NTP Inc for infringing their wireless email patents. Fortunately steps have been taken at a federal level. The passing of the Leahy-Smith American Patents Act in September 2011 has allowed any firm threatened with infringement to petition for a patent review within 4 months of being sued. Nonetheless the biotechnology sector must begin to reassess its patent rights and monitor such changes in legislation if it is to further grow as an industry.

About the author:

Fintan Burke is a student at the School of Biotechnology at Dublin City University. His main fields of interest include biomedical therapies and recombinant organisms.  Fintan may be contacted at fintan.burke2@mail.dcu.ie .

I’m back at work on the next issue of Scientific American Worldview, and I’m looking for interesting data sets that tell compelling stories about biotechnology and innovation in a comparative country-by-country basis.

Some of the datasets we’ve featured are agricultural biotechnology adoption, stock market liquidity, and corruption.

Some of the specific themes I’m looking for this year are access to medicines, regulatory burden, and industrial biotechnology research/productivity.

If you have any datasets to share, please drop me a line.

Drug Patent Expirations in February 2012

*Drugs may be covered by multiple patents

TradenameApplicantGeneric NamePatent NumberPatent Expiration
VISUDYNEQltverteporfin6,074,666Feb 5, 2012
GANIRELIX ACETATE INJECTIONOrganon Usa Incganirelix acetate4,801,577Feb 5, 2012
ALINIARomarknitazoxanide5,387,598Feb 7, 2012
AZILECTTevarasagiline mesylate5,786,390Feb 7, 2012
AZILECTTevarasagiline mesylate5,387,612Feb 7, 2012
AZILECTTevarasagiline mesylate5,457,133Feb 7, 2012
LOVENOXSanofi Aventis Usenoxaparin sodiumRE38743Feb 14, 2012
LOVENOX (PRESERVATIVE FREE)Sanofi Aventis Usenoxaparin sodiumRE38743Feb 14, 2012
LOVENOX (PRESERVATIVE FREE)Sanofi Aventis Usenoxaparin sodium5,389,618Feb 14, 2012
LOVENOXSanofi Aventis Usenoxaparin sodium5,389,618Feb 14, 2012
ACANYADow Pharm Scibenzoyl peroxide; clindamycin phosphate6,117,843Feb 18, 2012
OPTISONGe Healthcarealbumin human5,558,094Feb 28, 2012

This information is also available in an email newsletter: Subscribe to the DrugPatentWatch Patent Expiration Bulletin.

Courtesy of DrugPatentWatch.com