Monday 30 June 2014

Laboratory Design

When developing a laboratory and preparing the layout, it is important to recognize the required work capacity of the laboratory, the number of staff engaged in testing, the services (electricity, water, gas) required, and the mechanisms to control inadvertent release of microorganisms to the environment as well as cross-contaminations. Furthermore, the food microbiology laboratory is very operator dependent, and the design tends to be variable. There are, however, areas of commonality and examples of best practice. This chapter examines the design, space, and equipment considerations required for the construction and operation of a successful laboratory.

This is an extract from an article written by Tim Sandle for the new edition of the Encyclopedia of Food Microbiology. The reference is:

Sandle, T., 2014. Laboratory Design. In: Batt, C.A., Tortorello, M.L. (Eds.), Encyclopedia of Food Microbiology, vol 2. Elsevier Ltd, Academic Press, pp. 393–401

For more details about the Encyclopedia of Food Microbiology, please see: EFC

Posted by Tim Sandle

Sunday 29 June 2014

Virus Found in Sf9 Cell Line

A cell line derived from the larval moth Spodoptera frugiperda, called Sf9, is used for vaccine development. While the line has been thought to be free of viral contamination, researchers at the U.S. Food and Drug Administration (FDA) report in the June issue of the Journal of Virology that they’ve found a previously unidentified virus lurking in Sf9 cells.

While rhabdoviruses are common in plants, Sf-rhabdovirus is the first known to infect the insect group Lepidoptera. The analysis “indicated that the virus was most likely replicating in the cells, and its persistence indicated that it was constitutively produced from the Sf9 cell line,” the researchers wrote. The cell lines came from American Type Culture Collection and Invitrogen.

Given that little is known about this newly identified virus, the researchers wrote, “it is prudent to demonstrate the absence of Sf-rhabdovirus in cells used for the manufacture of biological products by sensitive testing at different stages of manufacturing or incorporation of viral clearance steps in the production scheme that can be validated using relevant model viruses.”
Posted by Tim Sandle

Saturday 28 June 2014

The role of microbiome in CNS disorders

We live with millions of microorganisms and these bacteria influence many aspects of our physiology. Studies have suggested that even mood and behavior may be affected by the microbiota.

Increasingly, scientists are investigating how central nervous system disorders are modulated by the microbiome, microbiota-derived products, and administered antibiotics and probiotics. Specifically, researchers have recently reported changes in microbial colonization and activity in the murine model of autism spectrum disorders (2014, Brain Behav. Immun. 37,197).

Posted by Tim Sandle

Friday 27 June 2014

Developments in medical device sterilisation technology

Over the past 40 years, there has been a significant change in how medical devices are manufactured, principally, from the use of metal and glass to medical grade polymers for single-use and disposable products. This shift, combined with more stringent regulations to more accurately address issues related to infection control, prompted the previous major change in sterilisation from steam autoclaving (often applied at the point of use, such as hospitals and doctors’ offices) to a requirement that products are delivered sterile by the manufacturer.

In relation to this, Edward Cappabianca, CEO, EnXray, has written an interesting overview of the technology for Cleanroom Technology.

The past few decades have seen little innovation in OEM medical device sterilisation methods, but today’s up and coming technologies could be more appropriate for the modern needs of manufacturers.

For further details, see Controlled Environments

Posted by Tim Sandle

Thursday 26 June 2014

Visualizing the Ocular Microbiome

Researchers are beginning to study in depth the largely uncharted territory of the eye’s microbial composition. There is an interesting article in The Scientist on this subject.

The researchers also found that during keratitis infections—infections of the cornea—only about half as many bacterial varieties were present, most prominently Pseudomonas strains. The changes typically occurred well before a diagnosis of an eye infection, suggesting the ocular microbiome could inform future diagnostics, Shestopalov noted. His team is refining the algorithm for predicting infection based on these changes to the make-up of bacteria and the timing of these changes.

One factor that may be expected to impact the composition of the ocular flora is the use of contact lenses. Contact lens wear is one of the biggest factors leading to corneal infection. Common bacterial infections that can cause irritation and redness affect an estimated 7 percent to 25 percent of contact lens-wearers, and much rarer keratitis infections can even cause blindness. Researchers believe contact lenses make it easier for pathogens to colonize the surface of the eye by giving the bacteria something to adhere to. Sequencing biofilms from used contact lenses, Shestopalov’s team found evidence of microbial communities that were different from the ocular microbiomes of people who don’t use contacts. On the lenses themselves, the researchers have found much less diversity—many of the bacterial genera that dominate the conjunctiva and cornea were depleted. In their place, Staphylococcus dominated.

For further details see: The Scientist 

Posted by Tim Sandle

Wednesday 25 June 2014

New E-Book: Bioprocessing & Sterile Manufacturing

Pharmaceutical Technology has issued a digital e-book which presents novel technologies for sterile manufacturing of small and large molecules, biologics, and offer technical insight into their formulation, manufacture, and delivery.

The topics include:
  • Continuous Biopharmaceutical Manufacturing
  • Isolator Sterilization
  • Sterilization of Liquids in Sealed Containers
  • Single-Use Technology for Syringe Filling
  • Compliance of Continuous Monitoring Systems

To access the e-book, go to Pharmaceutical Technology

Posted by Tim Sandle

Tuesday 24 June 2014

USP seeks comments on quality systems

Notice of interest via the USP:

Additional Feedback Sought on Proposed Storage and Distribution General Chapters (posted 13-Jun-2014)

USP is offering stakeholders the opportunity to provide additional feedback on the five newly proposed General Chapters related to storage and distribution that were recently published for comment in Pharmacopeial Forum 40(2) [Mar.–Apr. 2014]:
  • 1083 Good Distribution Practices
  • 1083.1 Quality Management System
  • 1083.2 Environmental Conditions Management
  • 1083.3 Good Importation and Exportation Practices
  • 1083.4 Supply Chain Integrity and Security

Please refer to the compendial notice posted on the USP Website for additional information.

Posted by Tim Sandle

Monday 23 June 2014

Classification of the Peronosporomycetes

Physiologically and morphologically, as obligately osmotrophic heterotrophs, the Peronosporomycetes are ‘fungi.’ They are phylogenetically separate from the Mycota (an alternative taxonomic name for the kingdom Fungi) and sometimes are described as Oomycota. The biflagellate, anisokont but nonstraminipilous Plasmodiophorales and the uniflagellate Chytridiomycetes likewise are unrelated. The Chytridiomycetes may be an early offshoot from the phylogenetic line leading tothe nonflagellate Mycota.

The Peronosporomycetes are algae fungi or cellulose fungi, form a class within the Stramenopilen, and therefore are much closer to brown algae, golden algae, and diatoms used as the genuine fungi. The taxa include several plant pathogens, such as the causative agent of late blight of potato and downy mildews.

The Peronosporomycetes include the most numerous, most important, and earliest known (with mid-eighteenth century reports for Saprolegnia on fish) water molds…

In relation to this, Tim Sandle has written an article for the new edition of the Encyclopedia of Food Microbiology. The reference is:

Sandle, T., 2014. Fungi: Classification of the Peronosporomycetes. In: Batt, C.A., Tortorello, M.L. (Eds.), Encyclopedia of Food Microbiology, vol 2. Elsevier Ltd, Academic Press, pp. 44–53

For more details about the Encyclopedia of Food Microbiology, please see: EFC

Posted by Tim Sandle

Sunday 22 June 2014

FDA Guidance: Hospital-Acquired Bacterial Pneumonia and Ventilator

The FDA has issued a new guidance document of interest to those working in healthcare. It is titled “Guidance for Industry Hospital-Acquired Bacterial Pneumonia and Ventilator- Associated Bacterial Pneumonia: Developing Drugs for Treatment.”

The introduction to the document reads:

“The purpose of this guidance is to assist sponsors and investigators in the clinical development of drugs for the treatment of hospital-acquired bacterial pneumonia (HABP) and ventilator associated bacterial pneumonia (VABP).2 Specifically, this guidance addresses the Food and Drug Administration’s (FDA’s) current thinking regarding the overall development program and clinical trial designs for drugs to support an indication for treatment of HABP and VABP. This draft guidance is intended to serve as a focus for continued discussions among the Division of Anti-Infective Products, pharmaceutical sponsors, the academic community, and the public.

This guidance was prepared with the general understanding that a noninferiority trial design evaluating patients who have HABP/VABP would be used to demonstrate effectiveness. This guidance revises the draft guidance for industry Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia: Developing Drugs for Treatment issued in November 2010. This guidance includes revisions to the primary efficacy endpoints, the enrollment criteria, the suggested primary efficacy analysis populations, and the noninferiority margin justification.”

To access the document, go to FDA

Thanks to Brian Matthews for the information.

Posted by Tim Sandle

Saturday 21 June 2014

Public consultation: use of antibiotics in animals

The European Medicines Agency has launched a public consultation concerning the use of antibiotics in animals.

One of the topics included is:

“Advice what the possible impact could be on the treatment of resistant bacteria in humans of granting marketing authorisations for new classes of veterinary antibiotics, and whether there is a need to restrict or ban the use in animals of certain new classes of antimicrobials or antibiotic substances (especially those that are important in human medicine) that are currently not authorised. It is stressed that the advice could discuss a positive impact (for example, better management of resistance in animals) or a negative impact (for example, increased risk of development of resistance in humans).”

A second important area is:

“Advice on the risk mitigation options [alternatives], including an assessment of costs and benefits, related with the use of certain classes of antibiotics or antibiotic substances that are of critical importance in human medicine and are currently authorised as veterinary medicinal products.”

To access the document, go to EMA

Thanks to Brian Matthews for the information.

Posted by Tim Sandle

Friday 20 June 2014

European Drug Target Review

Russell Publishing Ltd, the publishers of European Pharmaceutical Review has expanded its portfolio by launching European Drug Target Review, a business-to-business magazine that will feature the latest news, developments and insights in drug discovery for the changing landscape as companies restructure and look to new collaborations to discover new medicines.

The magazine, which will have a readership mainly across Europe but also with a presence in the US and Asia, is launching amid the growing success of European Pharmaceutical Review which is now in its 19th year and is continuing to build on its reputation as the gateway to Europe for pharmaceutical manufacturing and development.

Posted by Tim Sandle

Thursday 19 June 2014

New antibiotic in development

A new drug designed to treat tuberculosis could be the basis for a class of broad-spectrum drugs that act against various bacteria. Interestingly the drug may be capable of evading resistance.
The drug is called SQ109 and it attacks the tuberculosis bacterium. Scientist are looking to see how the drug can be modified to target other pathogens from yeast to malaria. By targeting multiple pathways, the scientists are of the opinion that this reduces the probability of pathogens becoming resistant.
Humans face the very real risk of a future without antibiotics. The implications of this are that life expectancy could fall due to people dying from diseases that are readily treatable today. Over the past year, various reports have been issued which highlight the problem of antibiotic resistant bacteria and the risks to human health.

Different research groups are examining new candidate antibiotics or different ways to get around the phenomenon of resistance. The team behind SQ109 think that the solution is multi-target drugs. Resistance in many cases arises because there's a specific mutation in the target protein so the drug will no longer bind. From this premise, one possible route to attacking the drug resistance problem is to devise drugs that have more than one target in the bacterial cell to attack.
SQ109 appears to block other proteins involved in critical functions in bacteria, fungi and parasites. The drug inhibits two enzymes that make the molecule menaquinone (Vitamin K2), which is involved in generating the microbial cell's energy. SQ109 also has a third action, called uncoupling, which makes the cell membrane permeable. This transforms the microbial cell membrane from a wall to a screen door. Importantly, it seems to have no affect in humans. These three mechanisms constitute the 'multi-targets'.
SQ109 is made by Sequella Inc., a pharmaceutical company. The researchers are working with international collaborators to apply SQ109 analogs against other infectious diseases.
The researchers are based at University of Illinois at Urbana-Champaign. The findings have been reported to the Journal of Medicinal Chemistry, in a paper titled ". Multitarget Drug Discovery for Tuberculosis and Other Infectious Diseases".

Posted by Tim Sandle

Wednesday 18 June 2014

MHRA Business Plan for 2014-15

The U.K. medicines regulatory, the MHRA has published its business plan for 2014-15.

This document sets out key work over the next year to progress MHRA’s 2013-18 Corporate Plan and how it will respond to the challenges and opportunities ahead.

These challenges include:
  • Section 4 Safe medicines and devices and secure supply in globalised industries where MHRA objectives are stated as:
  • Collaborate with other regulators to achieve a convergence of standards and practice, and make better use of global inspection audit and resources.
  • Ensure the quality of medicinal products on the market and act to avoid shortages.
  • Tackle the increasing risk of the illegal supply of medicines and devices.
  • Develop biological standards to underpin manufacturing consistency and dosing accuracy of biologics.

For more details, see MHRA

Posted by Tim Sandle

Bacterial Diseases and their Diagnosis

Bacterial diseases are among the most clinically important in the world. Diseases are cause by a range of different bacteria, including Gram positive cocci (such as Staphyloococcus aureus); Gram-positive rods (such as Mycobacterium tuberculosis); Gram-negative rods (such as Pseudomonas aeruginosa) and Gram-negative cocci (such as Neisseria gonorrhoeae). In order to help patients and to make the right clinical decision, fast and accurate diagnosis is required. This chapter surveys the major diseases and proceeds to consider the main methods for bacterial disease diagnosis. The chapter starts with the classic, cultural based approaches; then the serological techniques; before moving onto the more rapid, and accurate, methods of molecular biology, such as PCR. In doing so, the chapter provides an introduction to the topic of bacterial disease diagnosis.

This is the abstract of a new chapter by Tim Sandle for a new book about the diagnosis of disease. The book has been edited by Antonella Chesca (Faculty of Medicine, Transilvania University of Brasov, Romania).

The reference is:

Sandle, T. (2014) Bacterial Diseases and their Diagnosis. In Chesca, A. (Ed.) Techniques and Procedures for Disease Diagnostic, Lambert Academic Publishing, Saarbruken, Germany, pp31-60

For more details, please contact Tim Sandle

Posted by Tim Sandle

European anti-counterfeit database

A new database has been developed to assist authorities in the fight against counterfeit/falsified medical products.

 As part of its anti-counterfeiting activities, the EDQM has announced the launch of a new database called “Know-X”. This database collates reports on counterfeit/falsified medical products that have been detected in Council of Europe member states. The idea is to provide a user-friendly tool that will assist officials ( it is not available to industry / public) by expanding their knowledge and awareness of the problem of counterfeit/falsified medicines, provide a basis for the exchange of information, highlight and encourage collaboration between health and law enforcement authorities, and foster the sharing of analytical information on the testing of counterfeit/falsified and other illegal medicines within the Network of Official Medicines Control Laboratories (OMCLs).

For more details, see EDQM

Posted by Tim Sandle

Tuesday 17 June 2014

PCR for detection and identification of carbapanem hydrolysis β-lactamases genes

A new paper of interest has been published, titled: “The current state of PCR approach in detection and identification of carbapanem hydrolysis β-lactamases genes”. The paper has been written by Tim Sandle, Dmitriy Babenko, Alena Lavrinenko, Ilya Azizov and Antonella Cheșcă (Pharmig, Karaganda State Medical University and University of Brașov).

Here is the abstract:

“Antibiotic resistance is arguably the most serious health-related issue of the current time. This is even more so with carbapenem-resistant Enterobacteriaceae, for such microorganisms are resistant to the carbapenems (the ‘antibiotics of last resort’). One of the most important considerations is in the detection of bacteria that carry the carbapenem-resistant gene. For this, molecular-based phenotypic and genetic-based polymerase chain reaction (PCR) methods are available. In contrast to phenotypic methods, molecular-genetic techniques, such as PCR, are considered to have the potential for improved detection of carbapenem-resistant genes by virtue of specificity, accuracy and rapidity. The tendency in PCR techniques is to develop towards the real-time systems equipped with multiplexing functionality. However, as shown in our study, standard PCR with electrophoresis detection continues widely to be used for the detection and identification of the carbapenemase gene. Therefore, despite progress in PCR technology, methods deployed for the detection of serious hospital acquired infections around the world are arguably neither the most accurate nor the most efficient. This issue is of concern for pharmaceutical scientists in relation to the use and development of PCR technology and in relation to new drug development.”

The reference is:

Sandle, T., Banenko, D., Lavrinenko, A., Azizov, I. and Chesca, A. (2014) The current state of PCR approach in detection and identification of carbapanem hydrolysis β-lactamases genes, European Journal of Parenteral and Pharmaceutical Sciences, 19 (1): 153-164

To obtain a copy, please contact Tim Sandle

Posted by Tim Sandle

Monday 16 June 2014


Trichoderma spp. are cosmopolitan soil-dwelling molds. They attack diverse organic materials and through their degradative activities produce a range of potentially useful enzymes and secondary metabolites. A few species are invasive and present a concern to the production of certain foods, such as to the mushroom industry. Furthermore, one species, Trichoderma longibrachiatum, is a common house mold. On the more positive side, other species have been developed as biocontrol agents because they possess properties that are antagonistic to plant pathogens. Furthermore, certain species are used as stimulators of plant growth.

In relation to this, Tim Sandle has written an article for the new edition of the Encyclopedia of Food Microbiology. The reference is:

Sandle, T., 2014. Trichoderma. In: Batt, C.A., Tortorello, M.L. (Eds.), Encyclopedia of Food Microbiology, vol 3. Elsevier Ltd, Academic Press, pp. 644–646

For more details about the Encyclopedia of Food Microbiology, please see: EFC

Posted by Tim Sandle

Sunday 15 June 2014

Do industrial solvents help antibiotic resistance?

Chinese researchers have reported that some industrial solvents may help bacteria share an antibiotic resistance gene. This means that some solvents might be leading to a rise in certain bacterial diseases.
It has been a busy week for antibiotic resistant bacteria news. First came a new report released by the World Health Organization (WHO). The report, analyzed by Pharmaceutical Microbiology, described a "post antibiotic-era—in which common infections and minor injuries can kill—far from being an apocalyptic fantasy, is instead a very real possibility for the 21st century."
Second came an update from the campaign by U.S. Senator Sherrod Brown. Brown, as the Digital Journal reported, has proposed the Strategies to Address Antimicrobial Resistance (STAAR) Act. This is legislation aimed at combating antimicrobial resistance.

In addition to these important stories, a report published in the journal Environmental Science and Technology Letters indicates that some industrial solvents may help bacteria share an antibiotic resistance gene.
While so-called “ionic liquids” are usually touted as safer substitutes for volatile organic solvents, which can release volatile organic compounds (VOCs) in household solutions, such as furniture polishes, paint stripper, and air fresheners, one ionic liquid, 1-butyl-3-methylimidazolium hexafluorophosphate (which doesn’t release VOCs), increased by 500 times the abundance of a gene that makes bacteria resistant to the antibiotic sulfonamide. If the results are confirmed or shown to occur with other compounds, another worrying set of factors will concern scientists seeking to redress antibiotic resistance.

Posted by Tim Sandle

Saturday 14 June 2014

Lonely bacteria trigger antibiotic resistance

Bacteria that are found in lower numbers are more likely to mutate, resulting in higher rates of antibiotic resistance, new research has concluded.
Researchers have drawn a connection between the environment and the ability of bacteria to develop the resistance.
Specifically, the research team discovered that the rate at which E. coli mutates depends upon how many 'friends' it has around. It seems that more lonely organisms are more likely to mutate. Related research showed that low population of bacteria developed greater resistance to the well-known antibiotic Rifampicin, used to treat tuberculosis.
From these observations, the research team argue that the change of the mutation rate is controlled by a form of social communication known as quorum sensing -- this is the way bacteria communicate to let each other know how much of a crowd there is. Quorum sensing can occur within a single bacterial species as well as between diverse species, and can regulate a host of different processes, in essence, serving as a simple indicator of population density or the diffusion rate of the bacterium’s immediate environment.

Scientists hope to build on these observations in the fight against antibiotic resistance. The study was carried out at The University of Manchester and the results have been published in the journal Nature Communications, in a paper titled “Mutation rate plasticity in rifampicin resistance depends on Escherichia coli cell–cell interactions”.

Posted by Tim Sandle

Friday 13 June 2014

WHO endotoxin guidance

The World Health Organization is reviewing its guidelines for endotoxin testing. To examine what the changes might mean, Tim Sandle has written an article for the GMP Review.

The reference is:

Sandle, T. (2014) WHO updates endotoxin guidance for parenteral products, GMP Review, 13 (1): 7-8

For a copy, please contact Tim Sandle

Posted by Tim Sandle

Thursday 12 June 2014

Container Closure Integrity Testing

Preservation of container closure integrity (CCI) of a parenteral drug product is critical over the shelf-life of a product. Use of CCI testing is a viable alternative to sterility testing, and, according to FDA guidance, may be more useful than sterility testing in demonstrating the potential for product contamination over the shelf-life or dating period.

This important topic is examined by Louis Brasten, Barbara Jacobs, and Alicia Brydzinski for Controlled Environments magazine.

In the article, the authors note that there are many advantages to using CCI testing in lieu of sterility testing, including conservation of samples, fast results, and sensitivity that can pinpoint a leak in a vial or syringe system. It must be noted, however, that container and closure system integrity tests cannot demonstrate a product’s initial sterility.

The article can be accessed here.

Posted by Tim Sandle

Wednesday 11 June 2014

WHO updates endotoxin guidance for parenteral products

The WHO has issued a draft document for the establishment of endotoxin limits for parenteral preparations. Once approved, the text will be incorporated into the International Pharmacopoeia.

Tim Sandle has written a review article into this important topic. The reference is:

Sandle, T. (2014) WHO updates endotoxin guidance for parenteral products, GMP Review, 13 (1): 7-8

For further details, please contact Tim Sandle

Posted by Tim Sandle

Tuesday 10 June 2014

Multiple sclerosis 'linked to food bug'

A food poisoning bacterium may be implicated in MS, say US researchers.
Lab tests in mice by the team from Weill Cornell Medical College revealed a toxin made by a rare strain of Clostridium perfringens caused MS-like damage in the brain.
And earlier work by the same team, published in PLoS ONE, identified the toxin-producing strain of C. perfringens in a young woman with MS.
But experts urge caution, saying more work is needed to explore the link. No-one knows the exact cause of Multiple sclerosis (MS), but it is likely that a mixture of genetic and environmental factors play a role. It's a neurological condition which affects around 100,000 people in the UK.
C. perfringens, found in soil and contaminated undercooked meat, comes in different strains.
Most cases of human infection occur as food poisoning - diarrhoea and stomach cramps that usually resolve within a day or so. More rarely, the bacterium can cause gas gangrene.

And a particular strain of C. perfringens, Type B, which the Weill team says it identified in a human for the first time, makes a toxin that can travel through blood to the brain.
In their lab studies on rodents the researchers found that the toxin, called epsilon, crossed the blood-brain barrier and killed myelin-producing cells - the typical damage seen in MS.
Lead investigator Jennifer Linden said the findings are important because if it can be confirmed that epsilon toxin is a trigger of MS, a vaccine or antibody against the toxin might be able to halt or prevent this debilitating disease.
She presented the group's latest findings at a meeting of the American Society for Microbiology.
Dr Susan Kohlhaas, Head of Biomedical Research at the MS Society, said: "Discovering potential causes or triggers for MS could enable us to develop better treatments or even, one day, prevent the condition. This is interesting research but the findings now need to be validated in larger studies to establish if this toxin really is a potential trigger for MS."

Source: BBC Science

Monday 9 June 2014

New name for Irish Medicines Board

The following content has just been added to The Irish Medicines Board's website



On 1 July 2014, the Irish Medicines Board (IMB) will change its name to the Health Products Regulatory Authority (HPRA). We wish to give all our stakeholders advance notice so that you are aware of this change when you visit our website from 1 July and start to see documents and other materials displaying our new name and logo from that date forward. It may also be necessary for some organisations to update internal systems and records. Established in 1996, the IMB name has served us well. However, over the last 18 years our regulatory remit has expanded to include other health products...


Posted by Tim Sandle

Order of incubation for recovery of bacteria and fungi

One of the dilemmas for the environmental monitoring of controlled environments, when a single culture medium is used, is with the order and length of incubation. The two most common regimes adopted are either 20-25oC followed by 30-35oC and 30-35oC followed by 20-25oC. There have been very few published studies to help the microbiologist with the selection of the optimal incubation regime.

Tim Sandle has written a peer-reviewed research article for the International Journal of PharmaceuticalCompounding. In the article, Dr. Sandle presents experimental data which examines the optimal order of incubation and compares recovery rates for bacteria and fungi.

The conclusion of the study is that the incubation regime has an impact on the numbers of microorganisms recovered and the incidence of recovery. Specifically, where the recovery o fungi is important, the research indicates that the 20-25oC followed by 30-35oC is superior.

The reference for the paper is:

Sandle, T. (2014) Examination of the Order of Incubation for the Recovery of Bacteria and Fungi from Pharmaceutical Cleanrooms, International Journal of Pharmaceutical Compounding, 18 (3): 242 – 247

Posted by Tim Sandle

Sunday 8 June 2014

Weight loss: Is the secret in your bacteria?

The search for the most successful way to shed the pounds seems never-ending.
Now researchers in China have looked at what impact gut bacteria have on people's weight.
They think that changing the type of bacteria found in the gut may be more effective at helping people to shed weight than cutting calories alone.
But can it really be as simple as that?
Experts warn we shouldn't ditch the cucumber sticks and hot yoga just yet.
The latest World Health Organization figures show there were more than 1.4 billion adults aged 20 or older who were overweight in 2008.
Of these, 200 million men and nearly 300 million women were obese.

Those numbers are rising - they have doubled since 1980.Lab tests in mice found an association between bacteria and obesity, but trials with people are only just getting started.

In a clinical trial, published in the journal Microbiology Ecology, scientists in Shanghai studied 93 obese people who started with an average Body Mass Index (BMI) of 32.
They fed the volunteers supplements that promoted the growth of certain types of bacteria and reduced the levels of other bacteria in the gut, alongside a balanced diet.
At 30-day, nine-week and 23-week intervals, participants filled in a questionnaire about what they had eaten in the last 24 hours and were physically examined after overnight fasting. They were also weighed and measured.
People in the trial lost on average 5kg over nine weeks, and the 45% who carried on for 23 weeks lost on average 6kg. Their average BMI fell to 29.3.
One morbidly obese patient who was studied as a precursor to the trial lost 51kg, in six months - or about a stone every three weeks.
The paper says patients' levels of the C-reactive protein, linked to clogged arteries and damage to blood vessels in the heart, was also reduced during the trial.
But the study notes: "Admittedly, the self-controlled nature of this study does not allow to infer that all described effects are due to manipulation of gut microbiota."

The diet included prebiotics, such as artichokes
No cravings?
Prof Liping Zhao, at Shanghai Jiao Tong University, worked on the study.
He says higher levels of toxin-producing bacteria, such as enterobacteria, in the gut can lead to insulin resistance, which means people would not feel full after eating one bowl of rice, instead needing five, 10 or 20 bowls to feel full.
"Their bodies were not telling them they are satisfied," he says. Prof Zhao says changing the bacteria could switch on a gene which makes the body burn fat.
He says if a person is fed a calorie-restricted diet alone, their ability to lose weight could be impaired if their gut still contains high levels of the type of bacteria, which deactivates the gene that, he says, switches on fat-burning.
He adds: "It is about time to make the public see the kind of scientific evidence we have that really shows we can be confident that gut bacteria have a pivotal role in obesity."
Bacteria changing behaviour?
But there are doubts about the drivers of the effect.
When looking at the ever-complex world of the bugs living inside us, and the nuanced way these bacteria interact with our bodies, there are concerns about adopting hard and fast rules about what does and does not work.
Dr David Weinkove, at Durham University, said the study was interesting.But he said the study did not show whether or not changing the bacteria in the diet actually caused the weight loss, or was just linked to it.
Dr Weinkove adds: "What is interesting is whether the microbes can change your behaviour, and that is causing obesity. That is a really fascinating area."

Prof Sir Stephen Bloom, at Imperial College London, says: "There are 10 times more bacteria in the body than cells. We are basically trolleys carrying bacteria around so they can be fed."
He says there is "no question" that changing the bacteria in people's bodies can have significant effects. For example, he says, dysentery introduces different bacteria into the gut and causes weight loss.
'Eat less'
Prof Bloom says it is very hard to "disentangle" what makes people lose weight when they are put on diets, as just changing what people eat tends to make them lose weight, as they are doing something different from usual.
He says people in China have different bacteria to those in the UK, so it is difficult to compare.
His advice is simple: "Eat less and take more exercise. If you eat less, you will always lose weight."
Dr Alison Tedstone, director of diet and obesity at Public Health England, says: "Overall, obesity is about eating more calories than we expend. There are many things that impact upon our gut bacteria, the key one being what we eat.
"While interesting associations are described in the study, there remain issues with the translation of the studies into meaningful advice for the general public."
She advises people to eat a "healthy, balanced diet", and be active to get to a healthy weight.
Source: BBC News

Saturday 7 June 2014

Sheep dog patrols may curb seaside bacterial infections

Border Collies may be an effective weapon against E. coli infections at the seaside according to a new study.
Researchers found that the hard working sheep dogs were successful at keeping seagulls away from beaches.
Gull dropping are known to be a source of E. coli bacteria, which can lead to abdominal cramping and diarrhoea in humans.
High levels of the bug are a leading cause of beach closures in many parts of the world, including the UK.
The bacteria are commonly found in human and animal faeces and can end up in the seas through rain water run off or from sewage.
Seagulls have been implicated in the spread of resistant versions of the bug. A recent report showed that around a third of E. coli samples taken from the birds were resistant to more than one antibiotic.
Shore patrol
In this new study, researchers assigned the dogs to 200-metre stretches of beach along the shores of Lake Michigan in the US, which were patrolled for parts of the summer season. Half way through the dogs were switched to untreated sections.
Populations of Ring-Billed gulls have soared in the region since the 1970s with numbers increasing by 10% per year.
The collies, known for their intelligence and their herding abilities, disturbed the seagulls and kept them from landing on the beaches.
"Most of the time, the dogs were kept on their leads," said Dr Elizabeth Alm from Central Michigan University, who led the study.
"They were released with the leads dropped, only when their handler directed them to chase gulls. Then the dogs were called, they would circle back, and the handler would pick the lead back up."
Over the course of the summers of 2012 and 2013, the scientists recorded the number of birds at each section of beach while water and sand samples were collected and tested for E. coli.
They found that the bacterial counts were significantly lower on those sandy stretches where the dogs had kept the gulls at bay.
dog on the beachBorder Collies are known for their intelligence and are prized by sheep farmers for their ability to work hard
However the benefit didn't last through the whole season and the researchers found that later in the summer, bacterial numbers had risen once again. Dr Alm believes that the timing of the dog patrols is crucial to their effectiveness.
"If the E. coli establish in the sand early in the season, they appear to be able to persist, and probably even grow in the sand so that even though the dogs can remove the gulls from the beach later in the season, this late reduction in gulls does not translate in to a late season reduction in E. coli."
One key question though was the worry that the dogs themselves might increase the levels of E. coli if they had to answer nature's call while working on the beach.
"These were professional working dogs," said Dr Alm.
"They were given ample opportunity to take care of their "business" before going to work. They didn't often poop on the beach, but if they did it was immediately picked up by their handler and disposed of off the beach."
The research has been published at the annual meeting of the American Society for Microbiology.

Source: BBC Science

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