Sunday, 31 August 2014

Neglected Tropical Diseases (NTD) of the Developing World



FDA: Guidance for Industry Neglected Tropical Diseases (NTD) of the Developing World: Developing Drugs for Treatment or Prevention

The purpose of this guidance is to assist sponsors in the development of drugs for the treatment or prevention of NTDs of the developing world. Specifically, it addresses the Food and Drug Administration’s (FDA’s) current thinking regarding the overall drug development program for the treatment or prevention of NTDs, including clinical trial designs and internal review standards to support approval of drugs.

For details, see FDA

Posted by Tim Sandle

Saturday, 30 August 2014

Antibiotic resistance in foodborne germs is an ongoing threat

CDC report shows progress and problems among foodborne germs it tracks.

Antibiotic resistance in foodborne germs, an ongoing public health threat, showed both positive and troubling trends, according to data tracked by the Centers for Disease Control and Prevention in 2012. Each year, antibiotic-resistant infections from foodborne germs cause an estimated 430,000 illnesses in the United States. Multi-drug resistant Salmonella, from food and other sources, causes about 100,000 illnesses in the United States each year.

The most recent data showed that multi-drug resistant Salmonella decreased during the past 10 years and resistance to two important groups of drugs – cephalosporins and fluoroquinolones – remained low in 2012. However, in Salmonella typhi, the germ that causes typhoid fever, resistance to quinolone drugs increased to 68 percent in 2012, raising concerns that one of the common treatments for typhoid fever may not work in many cases.

About 1 in 5 Salmonella Heidelberg infections was resistant to ceftriaxone, a cephalapsorin drug. This is the same Salmonella serotype that has been linked to recent outbreaks associated with poultry. Ceftriaxone resistance is a problem because it makes severe Salmonella infections harder to treat, especially in children.

The data are part of the latest report of the National Antimicrobial Resistance Monitoring System (NARMS), a tri-agency surveillance system that has tracked antibiotic resistance in humans (CDC), retail meats (Food and Drug Administration), and food animals (U.S. Department of Agriculture) since 1996.  The report from CDC NARMS compares resistance levels in human samples in 2012 to a baseline period of 2003-2007.

“Our latest data show some progress in reducing resistance among some germs that make people sick but unfortunately we’re also seeing greater resistance in some pathogens, like certain types of Salmonella,” said Robert Tauxe, M.D., M.P.H, deputy director of CDC’s Division of Foodborne, Waterborne, and Environmental Diseases. “Infections with antibiotic-resistant germs are often more severe. These data will help doctors prescribe treatments that work and to help CDC and our public health partners identify and stop outbreaks caused by resistant germs faster and protect people’s health.”

Among the other findings in the 2012 report:
  • Campylobacter resistance to ciprofloxacin remained at 25 percent, despite FDA’s 2005 withdrawal of its approval for the use of enrofloxacin in poultry. Ciprofloxacin and enrofloxacin are both in the fluoroquinolone class of drugs.
  • Shigella resistance to ciprofloxacin (2 percent) and azithromycin (4 percent) is growing. However, no Shigella strains were resistant to both drugs.
  • Although fluoroquinolone resistance remained low in 2012, Salmonella enteritidis – the most common Salmonella type – accounted for 50 percent of infections resistant to the fluoroquinolone drug nalidixic acid, which is used in laboratory testing for resistance. Resistance to nalidixic acid relates to decreased susceptibility to ciprofloxacin, a widely used fluoroquinolone drug. Other work shows that many of the nalidixic acid resistant Salmonella enteritidis infections are acquired during travel abroad.
  • The report introduces a new method for interpreting Campylobacter data and includes links to online interactive graphs where users can choose an organism and an antibiotic and see the “bug-drug” trends from year-to-year in NARMS.

CDC NARMS monitors antibiotic resistance among clinical isolates of six types of common foodborne germs reported from all 50 states. In 2012, NARMS tested over 5,000 isolates for antibiotic resistance. By comparing results in 2012 with the baseline period of 2003-2007, NARMS provides important information on whether foodborne germs are gaining or losing resistance.

The FY 2015 President’s Budget requests funding for CDC to improve early detection and trackingof multidrug resistant Salmonella and other urgent antibiotic resistance threats.  The proposed initiative would increase CDC’s ability to test drug-resistant Salmonella  by 20 times.  With a $30 million annual funding level over 5 years, CDC estimates that it could achieve a 25 percent reduction in multidrug resistant Salmonella infections, as well as significant reductions in other resistant infections.

The full 2012 NARMS report is available on the CDC website. For more information see: NARMS.

Posted by Tim Sandle (thanks to Brian Mathews for the story idea)

Friday, 29 August 2014

International Journal of Microbiology and Allied Sciences

A new microbiology publication has been launched: 'International Journal of Microbiology and Allied Sciences'.


International Journal of Microbiology and Allied Sciences (IJOMAS) is a quarterly published, peer reviewed, multidisciplinary open access international journal. This journal publishes original research articles as well as review articles in all areas of microbiology and its different fields. ISSN: 2382-5537

In the current issue there are articles about:
  • The Test for Sterility of Medicinal Products
  • Assessment of Bacteriological contamination in Tooth brushes
  • Journey of Dengue from swat to Batkhela Malakand Agency, Pakistan
  • Enumeration of anaerobic periodontal pathogens from tuberculosis and chronic periodontitis patients by paper points and curettes: CFU based evaluation
  • Transmission of Tuberculosis and its Prevention

The first issue contains an editorial by me, which can be accessed for free. The details are:

Sandle, T. (2014) The Test for Sterility of Medicinal Products, International Journal of Microbiology and Allied Sciences, 1 (1): 1-9 (at: http://www.ijomas.com/wp-content/uploads/2014/08/Editorial1-Issue1.pdf)

Posted by Tim Sandle

Thursday, 28 August 2014

FDA to begin regulating medical laboratory testing

The US Food and Drug Administration (FDA) has announced that it will begin regulating medical laboratory testing and will start with the issuance of draft guidelines in the next 60 days. The regulations will require that laboratory tests that were developed in-house in a clinical setting—so-called laboratory-developed tests (LDTs)—and direct-to-consumer diagnostic tests, such as DNA sequencing kits, secure FDA approval.

“Ensuring that doctors and patients have access to safe, accurate and reliable diagnostic tests to help guide treatment decisions is a priority for the FDA,” FDA Commissioner Margaret Hamburg said in a statement. “Inaccurate test results could cause patients to seek unnecessary treatment or delay and sometimes forgo treatment altogether. Today’s action demonstrates the agency’s commitment to personalized medicine, which depends on accurate and reliable tests to get the right treatment to the right patient.”

The FDA said that the new regulations—which it will phase in over the next nine years—will focus on tests where an incorrect result could pose a high risk to patients.
Posted by Tim Sandle

Wednesday, 27 August 2014

Webinar on Media Fill Trials for Aseptic Process Control in Sterile Pharmaceutical Manufacture

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Optimizing workflows. Maximizing productivity.

Register Today: You’re Invited to an Exclusive Webinar on Media Fill Trials
for Aseptic Process Control in Sterile Pharmaceutical Manufacture
Together, Cleanroom Technology and Thermo Fisher Scientific present A Risk Matrix Approach for Media Simulation Trials in Sterile Pharmaceutical Manufacture.
In this exclusive webinar, we’ll explore important factors to consider when designing a media simulation trial program, and examine how these factors can be used to establish a risk-based matrix. You will also learn how single-use technology can aid safe and simple validation of aseptic manufacturing processes.

Register Now!
Presenters:Tim Sandle PhD – Head of Microbiology, Bio Products Laboratory Ltd (BPL)

Colin Booth – Global Director of Quality Assurance and Regulatory Affairs, Microbiology, Thermo Fisher Scientific

Time:9:00am CST, 3:00pm BST, 4:00PM CET

Date:September 24, 2014
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Pharmig News #56

A new edition of Pharmig News has been published. This is the official publication of the Pharmaceutical Microbiology Interest Group.

Highlights in the current issue include:

  • Cleanroom contamination control – a review of cleanroom mats and particulate control
  • EU GMP annex 15
  • Microbiology and regulatory news updates
The newsletter contains an article by Tim Sandle, the reference for which is:

Sandle, T. (2014) Examination of air and surface particulate levels from cleanroom mats and polymeric flooring, Pharmig News 56, pp2-8

For a copy of the newsletter, please contact Pharmig

Posted by Tim Sandle

Tuesday, 26 August 2014

Salmonella enteritidis outbreak linked to eggs


Public Health England is continuing to investigate a national outbreak of Salmonella enteritidis. Total reported numbers have reached 247 cases, from 158 on 15 August 2014. The additional cases are not new infections from the last 7 days, but historical cases reported to PHE during that week. Encouragingly, overall case reporting slowed over the last week.

Dr Paul Cleary, consultant epidemiologist at PHE, said: “Investigations into the recent Salmonella enteritidis outbreak are progressing, at both a national and European level. There is now evidence to indicate that cases in Europe with the same strains of Salmonella infection were associated with consumption of eggs from a single source. This egg supply also reached distributors and food outlets in England, but at this stage we cannot conclusively demonstrate this is the infection source in this country.

“We are continuing to work with the Food Standards Agency and public health organisations in Europe but, importantly, the decline in Salmonella case reporting this week alongside other elements of our investigations reassures us that the current risk to public health is low.”

Posted by Tim Sandle

Antonie van Leeuwenhoek - 80 years


Founded in 1934, Antonie van Leeuwenhoek is celebrating its 80th anniversary this year. Over the decades, the journal has successfully refined its content to embrace new developments, while remaining true to its roots as a journal of general microbiology, and has played a major part in the field.

The editors and publishers of the journal, for limited period, are providing free access to a special issue compiled to mark the 80 year milestone.

The contents are:
  • Celebrating the 80th anniversary of Antonie van Leeuwenhoek: a special issue
  • Still going strong: Leeuwenhoek at eighty
  • The origins of cellular life
  • Then and now: a systematic review of the systematics of prokaryotes in the last 80 years
  • Time to revisit polyphasic taxonomy
  • On the reclassification of species assigned to Candida and other anamorphic ascomycetous yeast genera based on phylogenetic circumscription
  • Indole-3-acetic acid in plant–microbe interactions
  • Pivotal roles for Streptomyces cell surface polymers in morphological differentiation, attachment and mycelial architecture
  • Impact of genomics on the field of probiotic research: historical perspectives to modern paradigms
  • 3-Ketosteroid 9α-hydroxylase enzymes: Rieske non-heme monooxygenases essential for bacterial steroid degradation
  • The re-emerging role of microbial natural products in antibiotic discovery

For access see: Antonie van Leeuwenhoek 

Posted by Tim Sandle

Monday, 25 August 2014

Techniques and Procedures for Disease Diagnostic

Antonella Chesca has edited an important and topical book considering methods to examine for pathogens. For this the book interweaves theoretical and practical information, and takes an international perspective to consider the methods adopted across different countries.

The book covers such subjects as the smear method for clinical practice, bacterial diseases, atherosclerosis, urothelial cell membranes, obesity, and biosensors.


The book contains a chapter by Tim Sandle. The reference is:

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

For further details see: Amazon

Posted by Tim Sandle

Sunday, 24 August 2014

New draft ISO 14644 standard



A new part of the ISO 14644 series of cleanroom standards has been drafted. This is “Cleanrooms and associated controlled environments — Part 14: Assessment of suitability for use of equipment by airborne particle concentration.”

The draft is concerned with the cleanroom classification of air cleanliness by particle concentration to the suitability of equipment (e. g. machinery, measuring equipment, process equipment, components, tools and so forth) for use in cleanrooms and associated controlled environments.

Proposed tests include:

  • Airborne particle concentration measurement: The aim is to confirm that the test environment is at least one ISO-ACP class cleaner than the cleanroom or clean zone within which the equipment is intended to be used.
  • Airflow velocity measurement. Guidance range for vertical velocity should be in the range of 0,3 m/s to 0,5 m/s.
  • Temperature, Guidance range should be 18 °C to 25 °C
  • Humidity, Guidance range should be 30 % RH to 70 % RH
Additional informative pre-tests may include:

  • Airflow direction test and visualisation
  • Electrostatic and ion generator test
  • Particle deposition test
To review a copy of the draft standard, contact your local standards office.

Posted by Tim Sandle

Saturday, 23 August 2014

WHO: Basic Hygiene Can Help Prevent MERS Spread

A World Health Organization official has urged people visiting Saudi Arabia, to exercise basic hygiene as mass gatherings pose risks of spreading the Middle East respiratory syndrome.

The U.N. agency has recorded 827 cases of MERS and 287 deaths, mostly in Saudi Arabia. The virus is believed primarily acquired through contact with camels and spread among humans through body fluids and droplets.

Hand washing and keeping away from coughing people are simple ways to prevent the virus' spread, said Mark Jacobs, WHO Western Pacific region director for communicable diseases.

For further details, see PharmaPro.

Posted by Tim Sandle

Friday, 22 August 2014

Ebola Outbreak Underestimated

here is a on-going debate about how fast the Ebola viruses are mutating. A new study suggests that the virus may not be evolving as quickly as a previous research group has estimated.

The Ebola virus causing havoc in West Africa may not be mutating at the fast rate previously thought by some medics. As detailed in new research, Ebola is evolving much slower in people than a 2014 study estimated. With the previous study, Harvard University medics genetically investigated Ebola samples blood samples from infected people in Sierra Leone. 
 
The inference was that the virus was quickly mutating. This research outcome led to the fear that the virus could become even more dealy. The research was published in the journal Science (in a paper called "Genomic surveillance elucidates Ebola virus origin and transmission during the 2014 outbreak.") However, with the new 2015 study, a different research group looking at Ebola cases in Mali, have found that the virus is not mutating fast. 
 
The lead author of the new research, David Safronetz, of the Laboratory of Virology at the National Institute of Allergy and Infectious Diseases (NIAID), has said in an interview with The New York Times Ebola "hasn’t become increasingly lethal or increasingly virulent...he virus—it’s doing what it’s always done." Reviewing the findings, Anthony Fauci (NIAID Director) told the science blogGoats and Soda blog: "This is some good news for the development of interventions. The data also indicate it’s quite unlikely the virus will mutate and change its way of transmission." 
 
 The new findings have been also been published in the journal Science. The research is called "Mutation rate and genotype variation of Ebola virus from Mali case sequences."

Posted by Tim Sandle

Strategic Cold Chain Management: USP, EC and Evolving Regulations

A new free eBook on meeting USP and EU GDP regulatory requirements has been issued by Vaisala.

According to Vaisala: “learn the latest revisions from the U.S. Pharmacopeial Convention (USP) Good Distribution Practices (GDP) according to the European Commission. This eBook provides simple, applicable recommendations on how to apply these guidances.”

For details, see: Vaisala.

Posted by Tim Sandle

Thursday, 21 August 2014

FDA - Expedited Programs for Serious Condition



Guidance for Industry on Expedited Programs for Serious Conditions-Drugs and Biologics

FDA is announcing the availability of a guidance for industry entitled “Expedited Programs for Serious Conditions—Drugs and Biologics”.

This guidance provides a single resource for information on FDA's policies and procedures related to the following expedited programs for serious conditions: (1) Fast track designation, (2) breakthrough therapy designation, (3) accelerated approval, and (4) priority review designation.

The guidance describes threshold criteria generally applicable to expedited programs, including what is meant by serious condition, unmet medical need, and available therapy. This guidance also discusses considerations for expedited development and review such as manufacturing and product quality, nonclinical studies, and clinical inspections. In addition, this guidance aligns CDER's criteria for priority review designation with CBER's criteria. Only products intended to treat a serious condition are eligible for priority review (unless otherwise eligible under specific statutory provisions).

For over 30 years, expediting the availability of promising therapies to patients with serious conditions has been a priority for FDA. With the passage of the Food and Drug Administration Safety and Innovation Act (FDASIA) (Public Law 112-122), FDA is expanding its efforts to expedite development and review of therapies intended to treat patients with serious conditions.

For more details, see FDA.

Posted by Tim Sandle

Wednesday, 20 August 2014

Ways to protect against Ebola


Ebola virus disease (EVD) has rarely been out of the headlines over recent weeks. This infectious disease has been causing panic across a number of African countries. Recently, Liberia declared a state of emergency and the outbreak has also hit Sierra Leone, Nigeria and Guinea. Meanwhile, a number of international aid workers have been infected and there are concerns that the disease could spread further.

Initially transmitted to people from wild animals such as forest antelope, chimpanzees and fruit bats, EVD spreads through the human population via person-to-person contact and it has a fatality rate of up to 90 per cent. People remain infectious as long as their blood and secretions contain the virus, and this can be up to seven weeks after they recover.

Individuals are at risk of contracting EVD if they have direct contact through broken skin or mucous membranes with the blood secretions, organs or other bodily fluids of infected individuals. Indirect contact with environments contaminated with these fluids can also lead to infection.

This means that, unless strict infection control precautions are in place, healthcare workers are in danger of falling ill with the disease if they treat patients with suspected or confirmed Ebola. There is not yet a licensed specific treatment or vaccine available.

Unprecedented

EVD first appeared in humans in 1976, but the current outbreak has proved particularly problematic. Indeed, it is the deadliest to date and has caused the World Health Organisation to announce an international health emergency. Meanwhile, the medical charity Medecins Sans Frontieres has described the outbreak as “unprecedented” in terms of the way the cases are scattered hundreds of kilometres apart across Guinea.

Reducing the risk of infection

Because there is not yet an effective treatment for the disease, it is particularly important for affected communities to take protective measures to reduce the risk of infection. Information plays a crucial role in the battle against EVD. People must understand the importance of avoiding close physical contact with infected patients, and this includes the burial of the dead.

In addition, strict rules must be observed in healthcare settings. For example, because the early symptoms of the disease may be non-specific, it is vital that personnel apply standard precautions with all patients, regardless of their initial diagnoses. These measures include basic hand hygiene, respiratory hygiene and the use of personal protective equipment.

As well as these standard precautions, healthcare workers should adhere to more specific infection control measures to avoid exposure to bodily fluids, as well as to any environments that may be contaminated. For example, such personnel should wear face shields or medical masks and goggles. They should also wear a clean, non-sterile long-sleeved gown and gloves.

Meanwhile, samples taken from suspected human and animal EVD cases for diagnoses in laboratories should only be handled by trained staff and they should be processed in suitably equipped environments.

Of course, all environments that are exposed to suspected and confirmed EVD patients must be thoroughly cleaned and disinfected on a continual basis. This is fundamental in the fight against the disease.

Strict hygiene control

Strict hygiene control measures can prove highly effective in preventing EVD cases, but in order to achieve the best results, people need all the relevant information and supplies.

The disease belongs to the virus family Filoviridae, which are filamentous enveloped viruses. These viruses can be rendered inactive by agents that target their lipid envelopes. This means that surface active biocides like the quaternary biocides found in Clinell Universal, as well as highly oxidative biocides such as the peracetic acid found in Clinell Sporicidal, can be effective in targeting EVD. It is now simple to access these infection control products. Firms such as Steroplast stock a selection of supplies, including Clinell Universal Wipes and Spray. These products can be used for the disinfection of surfaces, skin and equipment.

Such wipes and sprays are quick and easy to use and they can help to stop the spread of the disease. Other useful infection control products include surgical gloves, aprons, clinical waste bags and hand gels.



 Posted by Tim Sandle

Growing microbes from the human microbiome

By employing the use of a specially designed glass chip with tiny compartments, Caltech researchers have provided a way to target and grow specific microbes from the human gut. This is a key step in understanding which bacteria are helpful to human health and which are harmful.

Researchers started looking for bacterial species that contained a set of specific genetic sequences. To grow these microbes, the researchers turned to SlipChip, a microfluidic device. SlipChip is made up of two glass slides, each the size of a credit card, that have tiny etched grooves which become channels when the grooved surfaces are stacked atop one another. When a sample is added to the interconnected channels of the SlipChip, a single "slip" of the top chip will turn the channels into individual wells, with each well ideally holding a single microbe. Once sequestered in an isolated well, each individual bacterium can divide and grow without having to compete for resources with other types of faster-growing microbes.

The researchers then grew a compartment full of his target microbe in the SlipChip, and then they split the compartment in half. One half contains the live organism and the other half is sacrificed for its DNA to confirm that the sequence is that of the target microbe.

For further details, refer to the following paper:

L. Ma, J. Kim, R. Hatzenpichler, M. A. Karymov, N. Hubert, I. M. Hanan, E. B. Chang, R. F. Ismagilov. Gene-targeted microfluidic cultivation validated by isolation of a gut bacterium listed in Human Microbiome Project's Most Wanted taxa. Proceedings of the National Academy of Sciences, 2014; DOI: 10.1073/pnas.1404753111

Posted by Tim Sandle

Tuesday, 19 August 2014

Antibiotic Resistance Among Foodborne-Illness Germs a Mixed Bag: CDC

Report found reduced resistance to treatments with some bugs, more resistance among others

"Our latest data show some progress in reducing resistance among some germs that make people sick, but unfortunately we're also seeing greater resistance in some pathogens, like certain types of salmonella," Dr. Robert Tauxe, deputy director of the division of foodborne, waterborne and environmental diseases at the U.S. Centers for Disease Control and Prevention, said in an agency news release.TUESDAY, July 1, 2014 (HealthDay News) -- There's good news and bad news about antibiotic resistance among the germs that cause foodborne illnesses, a new U.S. government report released Tuesday shows.

Each year, antibiotic-resistant infections from foodborne germs cause about 430,000 illnesses in the United States, according to the CDC.

The agency's latest data, from 2012, show that multidrug-resistant salmonella, which causes about 100,000 illnesses a year, decreased during the past 10 years and resistance to two important types of antibiotics -- cephalosporins and fluoroquinolones -- remained low.

However, the rate of resistance to quinolone drugs in Salmonella typhi -- which causes typhoid fever -- rose to 68 percent in 2012. This means that this class of drugs, one of the most common treatments for typhoid fever, may no longer be effective.

The CDC also said that about 20 percent of Salmonella Heidelberg infections were resistant to the cephalosporin drug ceftriaxone. S. Heidelberg has been linked to recent outbreaks of illness associated with poultry.

Ceftriaxone resistance makes severe salmonella infections harder to treat, especially in children, the CDC noted.

Among the other findings:
  • Campylobacter resistance to the antibiotic ciprofloxacin remained at 25 percent, despite a 2005 ban on the use of the antibiotic enrofloxacin in poultry. Ciprofloxacin and enrofloxacin are both fluoroquinolone antibiotics.
  • Shigella resistance to ciprofloxacin (2 percent) and azithromycin (4 percent) increased, but no strains were resistant to both drugs.
  • Resistance to fluoroquinolones remained low. However, 50 percent of infections resistant to the fluoroquinolone drug nalidixic acid were caused by Salmonella enteritidis, the most common salmonella type.

Resistance to nalidixic acid -- used in laboratory testing for resistance -- is related to decreased susceptibility to a widely used fluoroquinolone drug ciprofloxacin, the CDC said in its release.

Many of the nalidixic acid-resistant Salmonella enteritidis infections among Americans are acquired when they travel to other countries.

SOURCE: U.S. Centers for Disease Control and Prevention, news release, July 1, 2014 (thanks to Brian Mathews for the story tip)

Posted by Tim Sandle

Monday, 18 August 2014

Advances in GC-MS Analysis of Pesticides

A new e-book of interest has been released. In the book, authors from the US Department of Agriculture, academia, and a European Union Reference Laboratory discuss advances in the analysis of pesticide residues using gas chromatography–mass spectrometry (GC–MS) methods.

Articles include discussions of:
  • How to improve detection limits and reduce matrix interferences to extend the range of pesticides that can be analyzed with GC
  • The advantages of negative chemical ionization (NCI) instead of electron ionization (ESI)
  • Using tandem mass spectrometry in SRM mode to improve selectivity
  • Lowering detection limits through large-volume injection (LVI) using cold on-column injection or a programmable-temperature vaporizer
  • The benefits of using an accurate-mass database for screening pesticides by GC-TOF-MS
  • A comparison of qualitative and quantitative results obtained using GC­–TOF-MS and GC-triple-quadrupole MS
  • Sample preparation using QuEChERS with acetonitrile extraction and dispersive solid-phase extraction (dSPE)
  • An evaluation and comparison of three dSPE sorbent combinations, comparing cleanup efficiency and contaminant recovery

For details see: Advanstar

Posted by Tim Sandle

Emergence of new antibiotics


Resistance also increases the cost of health care with lengthier stays in hospital and more intensive care required. This one aspect has seen a step-forward in relation to the unveiling of two new antibiotics. The first of the new antibiotics is called Dalvance. This is an intravenous drug that can treat skin and soft tissue infections. The second drug is called Oritavancin. Oritavancin is a lipoglycopeptide with bactericidal activity against Gram-positive bacteria. The drug was the subject of a clinical trial study led by G. Ralph Corey of Duke University, and the success was announced in the June 2014 edition of the journal The New England Journal of Medicine.

Although the emergence of two new antibiotics is promising, and will no doubt save many lives, their emergence represents also highlights the lack of progress in relation to other fields of medicine and how far there is still to go in the battle against bacterial ‘superbugs’.

A review of two new classes of antibiotics to treat skin infections forms the basis of a paper by Tim Sandle for the journal Clinical Journal of Microbiology and Pathology.

The reference is:

Sandle, T. (2014) Emergence of New Antibiotics. J Micro Patho Volume 1, Issue 1: 001

The paper can be accessed here.

Posted by Tim Sandle

Sunday, 17 August 2014

Clean Air and Containment Review



A new edition of Clean Air and Containment Review is available (issue 19). The features in the new edition include:


Main features
Isolators and the User Requirement Specification (URS):
How to avoid making your solicitors rich and your company poor
Tim Coles
Abstract →
A history of isolator and containment technology
Part 2: Flexible film isolators
Doug Thorogood
Abstract →
The HEPA filter installation leak test:
Factors influencing the test result and assessing the risk of a pass
Stephen Ryan
Abstract →
Regulatory reflections
Non-sterile pharmaceutical manufacturing:
USP chapter in development
Tim Sandle
Book review
Review of 'Pharmaceutical Regulatory Inspections' edited by Madhu Raju Saghee
James H Filer

For further details see CACR.

Posted by Tim Sandle

Oldest ever parasite egg found



The discovery of a schistosomiasis parasite egg in a 6200-year-old grave could provide the first evidence that agricultural irrigation systems in the Middle East contributed to disease burden.
The egg has been found in a grave at a prehistoric town by the Euphrates river in Syria. The egg was found in the pelvic area of the burial where the intestines and bladder would have been during life.
Schistosomiasis is a disease caused by several species of flatworm parasites that live in the blood vessels of the bladder and intestines. The parasite spends part of its life cycle in snails that live in warm fresh water, before leaving the snail to burrow through the skin of people wading or swimming in the water. Today it is estimated that over 200 million people around the world are infected.
The research suggests that the parasite may have been spread by the introduction of crop irrigation in ancient Mesopotamia, the region along the Tigris-Euphrates river system that covers parts of modern-day Iraq, Iran, Kuwait, Syria, and Turkey. Irrigation systems were starting to be introduced in Mesopotamia around 7,500 years ago. It is possible that these irrigation systems, that distributed water to crops, may have triggered the beginning of the disease burden of schistosomiasis some 6,000 years ago.
The finding also means that the parasite infected humans there at least a thousand years earlier than previously thought.
The finding has been published in the journal The Lancet Infectious Diseases. The paper is titled “Prehistoric schistosomiasis parasite found in the Middle East.”

Posted by Tim Sandle