Friday, 27 December 2013

Mushrooms produce wind to spread spores


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Mushrooms were thought to produce spores and for these to be carried in the wind in order to spread seeds around. Scientists have now shown mushrooms to be more sophisticated: they can make their own wind.
How do mushrooms spread their spores on a still day? Until recently biologists just assumed that they didn’t, and that on a still day mushrooms were not prone to passing spores to appropriate locations where they could reproduce.
It has now been shown that some species of mushroom have a mechanism whereby they can produce their own wind. This was discovered using high-speed videography and mathematical modeling of spore dispersal in commercially grown oyster and Shiitake mushrooms. Specifically mushrooms create their wind by releasing water vapor. The vapor cools the air locally, and this creates convective cells that move the air around in the mushroom’s vicinity.
The wind effect was shown by Emilie Dressaire, a professor of experimental fluid mechanics at Trinity College in Hartford, Connecticut. The findings were presented at the 66th Annual Meeting of the American Physical Society’s (APS) Division of Fluid Dynamics (DFD), held in November.

Posted by Tim Sandle

Thursday, 26 December 2013

Fecal transplants are 'successful'

Fecal transplants have begun to be used as a treatment over the past year. Now a long-term study confirms transplants of stool microbes from healthy donors can successfully clear recurrent Clostridium difficile infections.
With fecal transplants (or 'fecal bacteriotherapy'), as the Digital Journal has previously reported, aim to restore the balance between good bacteria and bad bacteria in the colon.
The procedure involves either single to multiple infusions (e.g. by enema) of bacterial fecal flora originating from a healthy donor, or, as a recent Canadian study showed, fecal transplant in pill form.
Now further evidence has emerged, in a PLoS One paper, about the success of the method. The paper, the Scientist notes, showed that patients given fecal microbiota transplants to treat recurrent Clostridium difficile infections cleared the bacteria in just days, and their intestinal microbiota were restored nearly to a pre-C. diff state within a year.
The new study was undertaken by University of Maryland School of Medicine’s Institute for Genome Sciences and Sinai Hospital in Baltimore, who used advanced genetic sequencing to screen a range of patient samples.
The reference for the research paper is:
Y. Song et al., “Microbiota dynamics in patients treated with fecal microbiota transplantation for recurrent Clostridium difficile infection,” PLOS ONE, 2013

Posted by Tim Sandle

Wednesday, 25 December 2013

Seasons Greetings


I would like to wish all readers of Pharmaceutical Microbiology, whatever their faith or culture, a peaceful time during this season.

Look forward to some interesting news items, research and comments for 2014.

Best wishes,

Tim Sandle

Tuesday, 24 December 2013

New models predict where E. Coli will thrive

Bioengineers at the University of California, San Diego have used the genomic sequences of 55 E. coli strains to reconstruct the metabolic sequenced for each strain. These reconstructions predict the kind of environment where each strain will thrive.

The reconstructions map out all the genes, reactions and products of metabolism for each strain and allow the researchers to probe their coordinated functionality. Each strain's metabolic capabilities, the researchers discovered, correspond to specific environmental niches. Commensal or "friendly" E. coli strains also can be distinguished from pathogenic strains using this technique.

The analysis has been published in the Proceedings of the National Academy of Sciences. For further details see U of C.

Posted by Tim Sandle

Monday, 23 December 2013

Disinfection Qualification Testing (white paper)


ATS Labs have an interesting new white paper titled "Disinfection Qualification Testing: Considerations for the Aseptic and Cleanroom Manufacturing Environment".

"This white paper, featuring an illustrative table on microorganism reduction of disinfectant active ingredients on routine surfaces, is intended to provide an overview of disinfection qualification testing and the considerations that must be addressed when designing and executing these studies."

For further details, see ATS Labs.

Posted by Tim Sandle

Sunday, 22 December 2013

Bruker's MALDI Biotyper Gets FDA Clearance to Identify Gram Negatives

Bruker Corporation has been granted U.S. FDA clearance under Section 510(k) to market its MALDI Biotyper CA System in the United States for the identification of Gram negative bacterial colonies cultured from human specimens.

The MALDI Biotyper CA System includes the bench-top microflex™ MALDI-TOF (matrix-assisted laser desorption ionization time-of-flight) mass spectrometer, software, IVD labeled reagents, a 48-spot MALDI target and a library of microorganism reference spectra. Bruker has conducted a multi-site clinical trial comparing performance of the MALDI Biotyper CA System to 16S ribosomal RNA gene sequencing. The overall accuracy of the MALDI Biotyper CA System was comparable to that of nucleic acid sequencing. FDA clearance of the MALDI Biotyper CA System is the latest achievement in Bruker's continuous efforts to develop MALDI-TOF mass spectrometry into the most advanced platform for clinical microbiology identification.

In 2009, Bruker launched a MALDI Biotyper system in compliance with the European in vitro diagnostic directive EC/98/79, making the CE-IVD labelled IVD-MALDI Biotyper the first MALDI-TOF based product registered for use in European clinical microbiology laboratories. Since then, Bruker has continued to expand into routine clinical microbiology and other markets throughout the world. Currently there are more than 1,000 systems sold or leased worldwide.

Posted by Tim Sandle

Saturday, 21 December 2013

Video: Mechanism of Resistance in Gram-negative Bacteria to Beta-Lactam Antibiotics

Gram-negative bacteria [such as Pseudomonas aeruginosa, Klebsiella pneumoniae and Escherichia coli] are becoming more resistant to the antibiotics we have available, leaving doctors with limited options to manage patients with infections caused by these organisms.

An interesting new video outlines some of the mechanisms involved.



Posted by Tim Sandle

Friday, 20 December 2013

ISO cleanroom working groups

Here is a list of the working groups that come under the ISO that are looking at cleanroom standards, primarily in relation to ISO 14644:

ISO/TC 209 Working Groups (WG)

WG 1 — Airborne particle cleanliness classes (active)
WG 2 — Biocontamination (active)
WG 3 — Metrology and test methods (active)
WG 4 — Design and construction (standby)
WG 5 — Cleanroom operation (standby)
WG 6 — Terms, definitions and units (standby)
WG 7 — Enhanced cleaning devices (standby)
WG 8 — Chemical contamination (active)
WG 9 — Clean surfaces (active)
WG 10 — Nanothechnology (active)
WG 11 — Assessment of suitability of equipment and materials for cleanrooms (active)
WG 12 — Cleaning of surfaces to achieve defined levels of cleanliness in terms of particle and chemical classification (active)

Posted by Tim Sandle

Thursday, 19 December 2013

New generation of biocides

A new generation of antibacterial materials have been developed. These are synthetic materials covered in nano-spikes resembling those found on insect wings. The material is an effective killer of microorganisms.
As reported in the Scientist, the material is a type of black silicon. The synthetic material is studded with needle-shaped nanostructures which serve as a potent antibacterial agent. Test have shown that the material can kill some 450,000 cells per minute in just one square centimeter.
Remarkably, what has been shown is that certain nanostructures can kill bacteria based on texture alone. The particles physically distort the microbial cell wall and break open the cell, thereby killing the microorganism.
The idea for the material, Sci News notes, came about after researchers recognized that dragonflies (Diplacodes bipunctata) also have similar nanopillars on their wings, and that black silicon was known for a similar nano-texture. The material is manufactured using bespoke ion-beam technology.
The importance of the new material is that it is potentially transferable to any material or fabric, and thus it has a great potential application in hospitals. A key advantage is that, unlike antibiotics, it would be far more difficult for bacteria to evolve structural resistance to black silicon.
The research was led by Elena Ivanova of Swinburne University of Technology in Australia, and the findings have been published in the journal Nature Communications. The article is titled "Bactericidal activity of black silicon".

Posted by Tim Sandle

Wednesday, 18 December 2013

Endotoxin detection: techniques and developments


American Pharmaceutical Review has issued a special supplement dedicated to endotoxin testing.

The supplement features interesting articles on the endotoxin concern of biologics (by Kevin Williams); regulatory issues pertaining to endotoxin testing (by Michael Dawson); a comparative study examining different methods of endotoxin destruction (by Tim Sandle); an examination of future developments in endotoxin testing (by Karen Zink McCullough); and preparation of a naturally occurring endotoxin challenge study (by Kim Bowers and Lynn Johnson).

The supplement also contains other information relating to endotoxin and LAL testing, and makes for a useful and interesting read in relation to more advanced aspects of the bacterial endotoxin test.

For further details, see APR.

Posted by Tim Sandle

Tuesday, 17 December 2013

U.S. aims to limit antibiotics for farm animals

The U.S. Food and Drug Administration (FDA) has laid out a plan so that farmers will no longer use antibiotics to fatten up animals.
The overuse of antibiotics for minor medical conditions (as reported by Digital Journal earlier this year) is not the only concern in relation to the rise of antibiotic resistant microbes. Antibiotic resistance is also occurring in fields and with farm animals.
Many farmers add antibiotics to animal feed or drinking water of cattle, hogs, poultry and other food-producing animals to help them gain weight faster or use less food to gain weight. One side-issue is that antibiotics can often end up in the environment - for example ending up in streams, being spread to crops as fertilizer, or getting carried around by birds - and so they are potentially a threat to public health. This relates to health issues with the human body and the accelerated rate of bacteria becoming resistant to the very drugs that are designed to kill them. This is a serious issue. According to the Washington Post, at least 2 million people in the United States become infected with antibiotic-resistant bacteria each year. At least 23,000 people die as a result.
Across the U.S., agricultural practices have been blamed for making this worse by using concentrated feed operations that leak antibiotics into surrounding waterways. This is not a new argument. Back in 1977, the FDA first pointed out that the non-therapeutic use of penicillin and tetracycline in livestock could give rise to new super-bugs resistant to antibiotics.


To slow the problem of antibiotic resistance, the FDA has announced new guidance for farmers. No longer will farmers be able to give animals antibiotics to make livestock or poultry grow bigger. Moreover, if an antibiotic is needed to treat a sick animal, farmers will have to get a prescription from a veterinarian. Importantly, this measure starts as a voluntary plan with industry and not a piece of legislation. Companies have 90 days to write to the FDA, saying they intend to follow the new program. After that, they’ll have three years to phase in the changes.
To explain why, Michael Taylor, deputy commissioner for foods and veterinary medicine at the FDA, told CNN: "With these changes, there will be fewer approved uses, and the remaining uses will be under tighter control."
As to whether pharmaceutical companies will co-operate, Taylor thinks that they will do so, adding "Based on our outreach, we have every reason to believe that animal pharmaceutical companies will support us in this effort."
statement from the FDA expands on this further: “Once manufacturers voluntarily make these changes, the affected products can then only be used in food-producing animals to treat, prevent, or control disease under the order of or by prescription from a licensed veterinarian."
Reactions from the farming community have been mixed. The American Meat Institute and the Animal Health Institute supports the move as apparent in a quote from Clinton Lewis, Jr., the executive vice president and president of U.S. operations for Zoetis, the country’s largest animal pharmaceutical company, who told POLITICO: “We agree with [FDA] that this is the fastest way to address their questions and concerns.”
As to whether the measures will work Rep. Louise Slaughter (D-N.Y.), is unsure. She has issued a statement where she says: "The FDA’s voluntary guidance is an inadequate response to the overuse of antibiotics on the farm with no mechanism for enforcement and no metric for success."
In support, Keeve Nachman, who studies food production at the Johns Hopkins Bloomberg School of Public Health, told Popular Science: "Even if it were observed by the industry, there’s no guarantee that the usage profile for these drugs would change."
With the FDA taking measures, calls have been made in Canada for a similar reduction in the use of antibiotics for farm animals. Dr. Doug Weir President Ontario Medical Association has told Medical News: "Ontario's doctors are concerned about the growing rate of antibiotic resistant bacteria. Patients are at risk of becoming sicker, taking longer to recover and it some cases dying from previously treatable diseases. Data shows that we can reduce antibiotic resistant bacteria when the use of antibiotics is modified. Adopting the recommendations in the report will help us achieve this."

Posted by Tim Sandle

Monday, 16 December 2013

Single use technology

Single-use, sterile disposable technologies (also referred to as biodisposable technologies or SUTs) are available in many formats and confer various advantages for pharmaceutical manufacturers. They comprise products generally manufactured from plastic polymers via the processes of injection moulding, extruding and blow moulding.

Single-use disposable items are most commonly used in aseptic processing as a contamination control measure. The applications include devices for making aseptic connections, sampling devices, mixing devices, product-hold bags and disposable manifold systems.

In relation to this technology, Tim Sandle has written an article for Cleanroom Technology. The reference is:

Sandle, T. (2013). Single-use technology for biopharma, Cleanroom Technology, December 2013, pp27-28

Dr. Sandle has also examined the advantages of single-use technology and some of the testing requirements for the Clean Air and Containment Review:

Sandle, T. (2013). Trends in healthcare cleanroom practice: single-use sterile disposable technology, Clean Air and Containment Review, Issue 16, pp18-20

If you are interested in reading either article, please contact Tim Sandle.

Posted by Tim Sandle

Sunday, 15 December 2013

BD study highlights risks of injectable medication errors

BD has published data from a new study that underlines the need for safer drug delivery practices in healthcare systems.

The company commissioned a US-based survey showing that preventable adverse drug events associated with injectable medications negatively impact more than one million inpatients each year.

This results in costs of $2.7 to $5.1 billion (1.68 to 3.17 billion pounds) in annual costs to US healthcare payers each year, or an average of $600,000 for every hospital.

According to the report, the types of medications and illnesses most associated with these harmful errors are already known, meaning measures can be taken to combat this trend.

For more details, see BD.

Posted by Tim Sandle

Saturday, 14 December 2013

Insight into anthrax infection


An anthrax infection can be fatal even when the infectious agent is no longer detected. Research carried out at EPFL reveals the way its lethal factor manages to turn invisible to the immune system.

The bacterium responsible for anthrax develops a strategy reminiscent of the Trojan horse tale. Its pathogenic factor is able to penetrate inside a cell in such a way that it becomes completely invisible to both the immune system and medical analysis. Furthermore, it manages to exit the cell several days later, and then it continues to poison other cells.

In a new study, researchers focused in the way the anthrax toxin was able to get inside the cell. Composed of two elements -- a "protective antigen" and a "lethal factor," the toxin does not merely create a passage across the cellular membrane. Instead, it introduces itself by endocytosis, a process by means of which the pathogen is "swallowed" by the cell. Once inside the cell, anthrax's lethal factor is sheltered by the cell's membrane, forming an "endosome," in which it can wait for several days. Then, it can either be released inside the cell, causing it to malfunction, or it can be released towards the external environment inside small vesicles -- called exosomes -- and get into another cell.

For further details, refer to the following paper:

Laurence Abrami, Lucia Brandi, Mahtab Moayeri, Michael J. Brown, Bryan A. Krantz, Stephen H. Leppla, F. Gisou van der Goot. Hijacking Multivesicular Bodies Enables Long-Term and Exosome-Mediated Long-Distance Action of Anthrax Toxin. Cell Reports, 2013; DOI: 10.1016/j.celrep.2013.10.019

Posted by Tim Sandle

Friday, 13 December 2013

Action required for antibiotic resistance

Antibiotic resistance is an international reality whose solution includes better educating physicians about using bacteria-fighting tools, says an infectious disease physician. In a statement, Dr. Josѐ A. Vazquez, Chief of the Section of Infectious Diseases at the Medical College of Georgia at Georgia Regents University, has said:

“The big problem is the overuse of antibiotics in hospitals and communities because not only can they lead to side effects like rashes and colon damage, one of those side effects is development of multidrug-resistant organisms.”

Emerging initiatives include antimicrobial stewardship programs that keep tabs on the antibiotics physicians prescribe and following up with education when inappropriate trends surface. Dr Vazquez adds: "We keep track to make sure patients are on the right antibiotic for the bug they have and use, when possible, a narrow spectrum antibiotic, instead of a broad-spectrum antibiotic.”

Furthermore: “Medical schools and residency training sites also need to beef up their educational efforts on the topic of appropriate antibiotic selection.”

Source: Medical College of Georgia at Georgia Regents University
Posted by Tim Sandle

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