Pharmaceutical Microbiology

Dr Rosemary Simpson

timsandle@btinternet.com (Tim Sandle) — Thu, 02 Feb 2012 15:35:26 PST

It is with great sadness that this blog reports on of the death of Dr Rosemary Simpson.

Dr Simpson was involved in a traffic accident some days ago and never regained consciousness.

Dr Simpson was an active member of the decontamination community. She was a member of many International standards bodies and was chairperson of BSI LBI/35 dealing with sterilizer and washer disinfector equipment. Along with Prof David Hurrell, Dr Simpson was a co founder of Health Care Sciences.
Posted by: Dr. Tim Sandle

Pharmig News #46 published

timsandle@btinternet.com (Tim Sandle) — Thu, 02 Feb 2012 14:51:00 PST

The new edition of the Pharmaceutical Microbiology Interest Group (Pharmig) Newsletter has been published (issue #46).

In the issue is:

Latest industry news by Tony Mayhall
An article about control charting by Tim Sandle and Jennifer Sandle
A review of the latest books for microbiologists
A review of Pharmig’s 19th annual conference, by Susan Birks of Manufacturing Chemist and Cleanroom Technology
The latest pharmaceutical and healthcare news

The newsletter is sent out to all member sites. To purchase an individual copy, contact the Pharmig office.

For those interested in my writing, the reference for the control charting article is:

Sandle, T. and Sandle, J. (2012). “Data Analysis – Shewhart Chart”, Pharmig News, Number 46, pp2-5

Posted by: Dr. Tim Sandle

Antibiotic Action

timsandle@btinternet.com (Tim Sandle) — Thu, 02 Feb 2012 06:30:00 PST

The British Society for Antimicrobial Chemotherapy has launched the campaign group Antibiotic Action to call for greater investment and interest in this area.

Antibiotic Action is a global initiative established by the British Society for Antimicrobial Chemotherapy (BSAC). The group hasserious concerns regarding the future effectiveness of currently available antibiotics and the lack of antibiotic agents in the drug pipeline. Antibiotic Action is a forum which calls upon all parties – government, health professionals, industry and charities – to identify and implement solutions within the research, regulation and economic markets to stimulate and regenerate interest in the discovery and development of antibiotic agents of the future.

For more details: Antibiotic Action
Posted by: Dr. Tim Sandle

Anti-infective drug shortages pose 'health threat'

timsandle@btinternet.com (Tim Sandle) — Wed, 01 Feb 2012 08:30:00 PST

A review in Clinical Infectious Diseases has indicated that shortages of key drugs used to fight infections represents a public health emergency in the USA, and could lead to patient's lives being put at risk. The review was undertaken by Marc Scheetz and Milena Griffith from Midwestern University Chicago College of Pharmacy and Northwestern Memorial Hospital.

The reasons for this relate to shortages of anti-infective drugs, a slowdown in the development of new anti-infective drugs and the increase of multi-drug resistant pathogens. In the report, the authors point to several supply-side issues which may account for supply issues. These include problems with procuring raw materials, processing, distributing, regulatory compliance, market shortages due to epidemics, new therapeutic indications, and perceived shortages.

The abstract to the study (Clin Infect Dis. (2012) doi: 10.1093/cid/cir954) reads:

"Anti-infective shortages pose significant logistical and clinical challenges to hospitals and may be considered a public health emergency. Anti-infectives often represent irreplaceable life-saving treatments. Furthermore, few new agents are available to treat increasingly prevalent multidrug-resistant pathogens. Frequent anti-infective shortages have substantially altered patient care and may lead to inferior patient outcomes. Because many of the shortages stem from problems with manufacturing and distribution, federal legislation has been introduced but not yet enacted to provide oversight for the adequate supply of critical medications. At the local level, hospitals should develop strategies to anticipate the impact and extent of shortages, to identify therapeutic alternatives, and to mitigate potential adverse outcomes. Here we describe the scope of recent anti-infective shortages in the United States and explore the reasons for inadequate drug supply."

For more about this issue, see Modern Medicine.

Main sources of food poisioning

timsandle@btinternet.com (Tim Sandle) — Wed, 01 Feb 2012 06:00:01 PST

Over 90% of cases of a common form of food poisoning seen this year were due to people eating undercooked chicken liver pate, often at weddings.

This is according to a news report by the BBC and based on an analysis by the Health Protection Agency (HPA), who analysed 18 outbreaks of Campylobacter in 2011 across England.

In all, 443 people became unwell and one had to be hospitalised.

The Food Standards Agency (FSA) has reminded caterers to cook poultry livers to prevent infection.

Campylobacter is the most common cause of bacterial food poisoning in Britain - there were estimated to have been more than 600,000 cases in 2010 in England and Wales.

Symptoms include diarrhoea, stomach pains and cramps, fever, and generally feeling unwell. Most people are only ill for a few days.

In 2008 there were just three outbreaks linked to undercooked chicken liver pate, but that rose to nine in 2009 and 14 in 2010.

Poultry livers carry a particularly high risk of Campylobacter as the bacteria can be present throughout the liver, not just the surface as is the case for other poultry meat, and may remain a source of infection if they are not cooked sufficiently.

Of the 18 outbreaks, 14 occurred in catering venues, and 13 of these were linked to chicken or duck liver pate.

Seven were linked to wedding receptions at hotels, banqueting venues or public houses and six were associated with catering at other functions such as hotels, clubs and restaurants.

The HPA found that livers used to make the parfait or pate were undercooked allowing the liver to remain pink in the centre.

It said caterers can reduce the risk of their people becoming infected by ensuring that Campylobacter is killed through proper cooking and by avoiding cross-contamination to other foods.'Inadequate cooking'

Dr Christine Little, an expert in gastrointestinal infections at the HPA, said: "The increase in outbreaks which are due to the consumption of chicken liver pate has been steadily increasing over the last few years.

"Not only is this dish popular in food recipe magazines, it is being served in a variety of different catering venues.

"Illness occurs because the livers are only cooked until they are pink, and inadequate cooking will not be sufficient to kill the bacteria.

"Both the public and the catering industry need to be aware that undercooking this product can result in food poisoning."

She said anyone planning a wedding, or other special event, should be aware of the risks if they were having chicken liver pate to prevent people becoming unwell.

The FSA issued updated advice to caterers on the safe handling and cooking of livers twice in 2010, but Campylobacter outbreaks associated with the consumption of chicken liver pate have continued to occur.

Bob Martin, head of foodborne disease strategy at the FSA, said: "Unfortunately, levels of Campylobacter in most raw chicken are high, so it's really important that chefs cook livers thoroughly to kill any bacteria, even if recipes call for them to be seared and left pink in the middle.

"The only way of ensuring the pate or parfait will be safe to serve to your guests or customers is by cooking the livers the whole way through.

"Caterers should also follow good general hygiene practices when cooking and handling poultry livers, to avoid cross contamination with Campylobacter."

Posted by: Dr. Tim Sandle

Hot microbiology and pharma topics!

timsandle@btinternet.com (Tim Sandle) — Tue, 31 Jan 2012 08:00:05 PST

Listed below are the mist popular microbiology, quality assurance, pharmaceutical and healthcare related items on this blog during the past month. Please have a look through, they will probably be something of interest.

If you have any suggestions for news items or comments on this site - pharmaceutical microbiology - please contact me.

Advances in cleanroom technologies

The gorgeous molecular biology movie

UK bacteraemia reports

Quality Management #1: Quality Management Systems

Laboratory data tables

Quality Control Laboratories: An Inspector's Guide

Air Quality and Cleanrooms (free on-line paper)

Bacillus anthracis and Anthrax: history

Evaluation of contact plates for environmental monitoring

Posted by: Dr. Tim Sandle

Quality Risk Management documents

timsandle@btinternet.com (Tim Sandle) — Tue, 31 Jan 2012 11:57:47 PST

A blog reader has asked me for a list of documents pertaining to Quality Risk Management. Quality Risk Management allows process and products, and in some cases personnel, to be better protected and it can be used to help to meet regulatory expectations and to meet cost demands or to seek process efficiency.

Here are the key ones (together with some relevant links):

Posted by: Dr. Tim Sandle

Choosing Cleanroom Clothing

timsandle@btinternet.com (Tim Sandle) — Mon, 30 Jan 2012 06:30:00 PST

Cleanroom clothing is an important part of contamination control, particularly in preventing operators from shedding skin (and thereby microorganisms).

Pharmaceutical Technology Europe have an interesting interview with Jaime Cassar, cleanroom category manager at Kimberly-Clark Professional Europe, about the importance of sterile garments for cleanroom environments.

Here is an extract:

How can the protection provided by sterile clothing help to create process improvements?

The cleanliness of sterile clothing is important to consider in order to prevent the clothing from itself becoming a source of contamination. For example, sterile gloves that have been washed in di-ionised water, cleanroom packed, sterile validated and specified for low endotoxin levels can help lower the risk of particle, microbiological and endotoxin contamination. Sterile apparel that is laundered, cleanroom packed in individual vacuum packaging, double-bagged and provided with periodic sterile validation will also contribute to lower contamination risks. Sterile gloves made from synthetic materials are beneficial because they can eliminate the risk of contaminating the final product with rubber latex proteins, which can be a problem for patients with latex allergies.

Another crucial point is the barrier performance of the clothing. Continuous improvement can come from better control or elimination of variability in attributes that impact barrier performance. For example, disposable apparel eliminates the risk of variability in filtration efficiency and material strength that may come from re-wearing, re-washing and re-sterilising apparel many times and over a long period of time. Sterile apparel made from stronger materials and sterile gloves with a higher quality film formation will be more resistant to breakage and are more likely to be free from any pinhole type defects.

As well as protecting the process from contamination, sterile clothing should also protect the wearer from the health and safety risks presented by chemicals and APIs. Sterile gloves tested to show longer resistance times to permeation by cytotoxic chemicals and sterile clothing certified to provide protection against chemical splashes can contribute to better protection for the wearer. In Europe, sterile gloves and apparel should be Category III certified under the personal protective equipment (PPE) directive 89/686/EEC, if there is risk of exposure to chemicals and APIs. There are also other ways to protect wearers from health and safety risks. For example, sterile clothing that is biocompatible can mitigate the risk of the clothing causing irritation to the wearer, and sterile gloves that are free from natural rubber latex will eliminate the risk of latex allergies.

Posted by: Dr. Tim Sandle

Sustainable water-treatment process using tree seeds

timsandle@btinternet.com (Tim Sandle) — Sun, 29 Jan 2012 15:18:51 PST

A material derived from seeds of a tree, sometimes called the "miracle tree", could purify and clarify water inexpensively and sustainably in the developing world, where many millions of people lack access to clean drinking water. Research, led by Stephanie Velegol, on the potential of a sustainable water-treatment process requiring only tree seeds and sand has been reported in the journal Langmuir.

Velegol looked to Moringa oleifera, also called the "miracle tree," a plant grown in equatorial regions for food, traditional medicine and biofuel. Past research showed that a protein in Moringa seeds can clean water, but using the approach was too expensive and complicated. So Velegol's team sought to develop a simpler and less expensive method.

To achieve this, the researchers added an extract of the seed containing the positively charged Moringa protein, which binds to sediment and kills many microorganisms, to negatively charged sand. The resulting "functionalized," or "f-sand," proved effective in killing harmful E. coli bacteria and removing sediment from water samples. The results could lead to applications using f-sand to provide a simple, locally sustainable process for producing storable drinking water.

The moringa tree is grown mainly in semi-arid, tropical, and subtropical areas, corresponding in the United States to USDA hardiness zones 9 and 10. While it grows best in dry sandy soil, it tolerates poor soil, including coastal areas. It is a fast-growing, drought-resistant tree that is native to the southern foothills of the Himalayas in northwestern India.

The journal reference is: Huda A. Jerri, Kristin J. Adolfsen, Lauren R. McCullough, Darrell Velegol, Stephanie B. Velegol. Antimicrobial Sand via Adsorption of Cationic Moringa oleifera Protein. Langmuir, 2011
Posted by: Dr. Tim Sandle

Cleanroom cleanliness classes

timsandle@btinternet.com (Tim Sandle) — Sat, 28 Jan 2012 18:30:00 PST

Here is a table showing the comparison between EU GMP cleanroom grades and ISO 14644 cleanroom classes.

	At Rest
	0.5 µm				5.0 µm
Grade	Annex 1		ISO 14644-1 (Class) Count		Annex 1		ISO 14644-1 (Class) Count
A	3,520		(5) 3,520		20		(4.8) 20
B	3,520		(5) 3,520		29		(5) 29
C	352,000		(7) 352,000		2,900		(7) 2,930
D	3,520,00		(8) 3,520,000		29,000		(8) 29, 300
		Operational
		0.5 µm				5.0 µm
Grade		Annex 1		ISO 14644-1 (Class) Count		Annex 1		ISO 14644-1 (Class) Count
A		3,520		(5) 3,520		20		(4.8) 20
B		352,000		(7) 352,000		2,900		(7) 2,930
C		3,520,000		(8) 3,520,000		29,000		(8) 29,300
D		Not Defined				Not Defined

Posted by: Dr. Tim Sandle

Can intestinal bacteria influence mood?

timsandle@btinternet.com (Tim Sandle) — Sat, 28 Jan 2012 06:27:35 PST

Many of the bacteria which reside in the human gut, are beneficial, helping people with digestion and keeping the intestines in good working order. This is fairly well established in scientific research.

From this starting point, there is a small, but steadily growing, body of evidence which suggests that bacteria dwelling in the gut can affect the brain, too, and thereby influence an individual’s mood and behaviour. A recent paper on the topic was recently published in the Proceedings of the National Academy of Sciences. The study reports on results in mice.

The researchers, led by Javier Bravo of University College, Cork, split their rodent subjects into two groups. One lot were fed a special broth containing Lactobacillus rhamnosus, a gut-dwelling bacterium often found in yogurt and other dairy products. The others were fed an ordinary diet, not fortified with microbes.

The team then subjected the mice to a battery of tests that are used routinely to measure the emotional states of rodents. Most (though not all) of these tests showed significant differences between the two groups of animals.

One test featured a maze that had both enclosed and open tunnels. The researchers found that the bacterially boosted mice ventured out into the open twice as often as the control mice, which they interpreted to mean that these rodents were more confident and less anxious than those not fed Lactobacillus.

In another test the animals were made to swim in a container from which they could not escape. Bacteria-fed mice attempted to swim for longer than the others before they gave up and had to be rescued. Such persistence is usually interpreted by students of rodent behaviour as evidence of a more positive mood.

Direct measurements of the animals’ brains supported the behavioural results. Levels of corticosterone, a stress hormone, were markedly lower in the bacteria-fed mice than they were in the control group when both groups were exposed to stressful situations. The number of receptors for gamma-aminobutyric acid, a natural chemical messenger that helps dampen the activity of certain nerve cells, varied in statistically significant ways between the brains of the two groups, with more in some parts of the treated animals’ brains and fewer in others. Most intriguing of all, when Dr Bravo cut the animals’ vagus nerves—which transmit signals between the gut and the brain—the differences between the groups vanished.

Some doubts, however, remain. Dr Bravo and his colleagues do not yet know the precise mechanisms at work. The key question which emerges from the research is whether a similar effect occurs in people. Studies which use bacterial treatments to help with mental symptoms of illnesses such as irritable-bowel syndrome would suggest so.

All this is forcing a reassessment of people’s relationship with the bacteria that live on and in them, which have long been regarded mainly as a potential source of infections.

Reference: Bravo, Forsythe, Chew, Escaravage, Savignac, Dinan, Bienenstock & Cryan. 2011. Ingestion of Lactobacillus strain regulates emotional behavior and central GABA receptor expression in a mouse via the vagus nerve. PNAS http://dx.doi.org/10.1073/pnas.1102999108

For further information: University of Cork

Posted by: Dr. Tim Sandle

Hepatitis drug developments

timsandle@btinternet.com (Tim Sandle) — Sat, 28 Jan 2012 01:55:37 PST

Two new drugs have recently been approved to help those suffering from the virus hepatitis C. The FDA have approved Incivek (telaprevir) from Vertex Pharmaceuticals and Merck’s Victrelis (boceprevir). Both pills are protease inhibitors that interfere with the liver-infecting virus's ability to replicate, and each drug can be combined with existing treatment to make the life of the patient easier and closer to 'normal'. The development was reported in The New York Times.

Further in relation to hepatitis treatment, the pharmaceutical company Gilead recently purchased the biotech company Pharmasset and its hepatitis C development program for $11 billion. Also on the subject of acquisitions, Johnson & Johnson and Bristol-Myers Squibb are jointly working on a hepatitis C drug combination, which is set to begin Phase III clinical trials in 2012

Read more: see a special report on the Digital Journal site

Posted by: Dr. Tim Sandle

WHO HVAC Document (revised edition)

timsandle@btinternet.com (Tim Sandle) — Fri, 27 Jan 2012 06:00:05 PST

The World Health Organization has revised their guidance on Heating Ventilation and Air Conditioning (HVAC) systems. This forms part of Technical Report 961, as Annex 5.

The document covers the following topics: products and personnel, air filtration, unidirectional airflow, infiltration, cross-contamination, displacement concept (low pressure differential, high airflow), pressure differential concept (high pressure differential, low airflow), physical barrier concept, temperature and relative humidity, protection of the environment, design of HVAC systems and components and commissioning, qualification and maintenance.

The introduction to the document reads:

“This document aims to give guidance to pharmaceutical manufacturers and inspectors of pharmaceutical manufacturing facilities on the design, installation, qualification and maintenance of the HVAC systems. These guidelines are intended to complement those provided in Good manufacturing practices for pharmaceutical products and should be read in conjunction with the parent guide. The additional standards addressed by the present guidelines should, therefore, be considered supplementary to the general requirements set out in the parent guide”

The document can be found at: WHO HVAC

Posted by: Dr. Tim Sandle

UK invests £1m in infectious agents projects

timsandle@btinternet.com (Tim Sandle) — Thu, 26 Jan 2012 12:24:58 PST

The UK government (via the Technology Strategy Board) has announced that it will invest £1 million into three major projects to enable them to develop new and improved health-economics tools or products that will assist and improve the design and evaluation of diagnostic clinical trials for infectious agents.

One of the stated aims of the project is to reduce the economic burden, death and illness due to infectious agents.

Iain Gray, Chief Executive of the Technology Strategy Board, says on the wesbite:

“Supporting innovation in healthcare is a priority for the Technology Strategy Board. Through these contracts we look forward to seeing the development of new and improved health- economics modelling tools that will help companies and organisations design and evaluate diagnostic clinical trials. We hope these new tools will lead to better adoption of diagnostic products by providing assessors and decision-makers with high-quality data on their impact.”

Two of the projects, to be undertaken by Diagnostics for the Real World and the Health Protection Agency, will focus on sexually transmitted infections, while the Integrated Medicines Ltd project will focus on sepsis

Posted by: Dr. Tim Sandle

Real-time counting of airborne particles and microorganisms

timsandle@btinternet.com (Tim Sandle) — Sat, 28 Jan 2012 01:56:43 PST

One of the recent and exciting new technologies to emerge are those which measure particles from samples of air and distinguish between non-viable an viable particles. Although the technology remains in its infancy, the potential applications are substantial.

In order to provide an overview, Tim Sandle has written an article for the latest edition of Clean Air and Containment Review. Here is an extract:

"Over the past few years some new technologies for air-sampling have been developed (bio-air systems). The instruments are real-time optical spectroscopy counting instruments designed to simultaneously detect the number and size of particles from a volume of air. This is much like the way a conventional particle counter estimate particles by measuring light scattering. The difference is that the instruments are capable of determining if the detected particles are biological. Thus the key innovation is that such devices can differentiate between non-viable particles and biological material, which may indicate if microorganisms are present in the sample of air.

The implementation of such technologies is in keeping with the industry and regulatory drive, particularly from the US Food and Drug Administration, for rapid methods and for pharmaceutical manufacturers to utilise the concept of process analytical technology (PAT). PAT is a set of mechanisms to design, analyse, and control pharmaceutical manufacturing processes through the measurement of critical process parameters. With the PAT philosophy the ideal is to male such assessments in ‘real-time’, so that quality issues can be addressed during batch manufacture."

The reference is:

Sandle, T. (2012). "Real-time counting of airborne particles and microorganisms: a new technologcal wave?", Clean Air and Containment Review, Issue 9, pp4-6

Posted by: Dr. Tim Sandle

EMA - Revising Annex 16 of the Guide to Good Manufacturing Practice

timsandle@btinternet.com (Tim Sandle) — Thu, 26 Jan 2012 06:30:00 PST

The European Medicines Agency (EMA) has published a discussion document entitled “Concept paper on Revising Annex 16 of the Guide to Good Manufacturing Practice: Certification by a Qualified Person and Batch Release”

The introduction to the paper reads:

“Annex 16 of the Guide to Good Manufacturing Practice for Medicinal Products gives guidance on the certification and batch release of medicinal products within the European Union and European Economic Area. Since introduction of the Annex in 2002, the pharmaceutical business environment has changed and new technologies have developed. The supply chains have become quite complicated through globalisation, and new falsified medicines legislation has been approved. Modern control techniques such as Process Analytical Technology, Real Time Release Testing and implementation of ICH Q8, Q9 and Q10 documents, as well as progress in biotechnology and advanced therapy medicinal products, are examples of developments which call for a thorough review of the Annex. In addition there are a number of areas where clarification is required, including the documentation (or equivalent system) to verify that batches moving between Member States have undergone certification, the sampling and testing of batches produced in third countries and dealing with minor deviations from marketing authorisations.”

The consultation ends on 31^st January 2012.

The document can be found at: EMA document

Posted by: Dr. Tim Sandle

Book Feature: Laboratory Design

timsandle@btinternet.com (Tim Sandle) — Wed, 25 Jan 2012 09:00:00 PST

Laboratory Design: Establishing the Facility and Management Structure, Scott V. W. Sutton (Editor)

This book is highly recommended.

This book focuses on the design procedures that minimize the likelihood of error. It also explains how to design the laboratory facility to maximize the ability of staff to get their work done in an efficient and effective manner by describing the best practices available for design planning, technical proficiency and careful data analysis. The book organized by three main topics: Microbiology in the Company; Quality Systems for Microbiology; Microbiology Lab Design and Layout. The goal of the book is to provide help to those who are interested in learning the perspectives of industry leaders, to better organize the microbiology lab, to meet the corporate needs as well as reflect the organization not only in the facility but in the laboratory procedures and training. This book is unique in looking at the question of lab design from a purely microbiological perspective and offers concrete direction to setting up your systems and facilities to minimize errors and data variability.

The book is available from Amazon (US) here:

Posted by: Dr. Tim Sandle

Horseshoe crabs

timsandle@btinternet.com (Tim Sandle) — Wed, 25 Jan 2012 06:00:09 PST

Two different species of horseshoe crab are permitted to be used by the pharmacopoeias for the pharmacopoeial endotoxin test (the ‘LAL’ test).

These are:

Tachypleus tridentatus

Limulus polyphemus

Tachypleus tridentatus is a species of horseshoe crab found in China, Indonesia, Japan, Malaysia, the Philippines, Taiwan, and Vietnam.

Limulus polyphemus is a marine chelicerate arthropod. They are most commonly found in the Gulf of Mexico and along the northern Atlantic coast of North America.

There are two other species of horseshoe crab: Tachypleus gigas and Carcinoscorpius rotundicauda. These two other species occur along the east coast of India. Although the four species in the family Limulidae are of similar form and behaviour, T. gigas and C. rotundicauda are not listed in the pharmacopoeia for use in the endotoxin test.

Of the two permitted crabs: Tachypleus tridentatus and Limulus polyphemus, both crabs are used to produce an amebocyte lysate which is used for the pharmacopoeial endotoxin test (the LAL: Limulus amebocyte lysate test or the TAL: Tachypleus amebocyte lysate test). This is an in vitro test for the detection of Gram-negative bacterial endotoxins.

Endotoxins from Gram-negative bacteria are the most common cause of toxic reactions resulting from contamination of pharmaceutical products with pyrogens; their pyrogenic activity is much higher than that of most other pyrogenic substances. These endotoxins are lipopolysaccharides.

The principle of the test is based on the physiological affect whereby the blood of horseshoe crabs contains one type of blood cell, the amebocytes (sometimes called hemocytes). These play an important role in the defence against pathogens. Amebocytes contain granules with a clotting factor known as coagulogen; this is released outside the cell when bacterial endotoxin is encountered. The resulting coagulation is thought to contain bacterial infections in the animal's semi-closed circulatory system.

Biochemical studies on the principle of Limulus test indicate that the amebocytes

contain several serine protease zymogens, which constitute a coagulation cascade triggered by endotoxins, and that there is a (1,3)-β-D-glucan-mediated coagulation pathway which also results in the formation of gel.

With the LAL / TAL test, this is based on the use of a lysate of amoebocytes from the horseshoe crab where the addition of endotoxin to this lysate may result in gelation, precipitation or turbidity.

Posted by: Dr. Tim Sandle

Emerging Talent in Pharmaceutical Microbiology (Thermo Fisher Scientific Award)

timsandle@btinternet.com (Tim Sandle) — Tue, 24 Jan 2012 08:00:04 PST

(a picture of my garden)

Thermo Fisher have announced the Oxoid Prize for the Best Project in Microbiology (2011), at the University of Brighton School of Pharmacy and Biomolecular Sciences. This has been awarded has been awarded to final year student, Christopher Lee.

The award acknowledges Christopher’s investigations into the in vitro interactions between fluoroquinolone and aminoglycoside antibiotics, with a particular interest in any synergistic effect.

To read more about the award and the recipient, go to: Thermo Fisher.

Posted by: Dr. Tim Sandle

Science and the social media

timsandle@btinternet.com (Tim Sandle) — Tue, 24 Jan 2012 04:30:01 PST

Some useful 'social media' websites for scientists.

PLoS

“Since 2000, PLoS’s mission has been to make ‘the world’s scientific and medical literature a freely available public resource.’”

A repository for papers and for gaining access to articles.

Faculty of 1,000

A free article site and one which allows peer-reviewing, making it one of the most active open-access platforms. Scientists rank articles and journals too.

Scholarpedia

This is built with the same software as Wikipedia, but each article is attributed to an author who is an expert in their field. This gives more credibility to Scholarpedia with the scientific community. Scholarpedia still uses the power of crowdsourcing because people can submit edits to articles which are approved by the article moderator. This allows another principle of science, debate!

Vimeo

This is a video site alternative to Youtube, which scientists seem to prefer. The videos are typically better quality and the channels are more targeted. It’s easier to search videos by topic with less “junk” than on Youtube. Videos are more educational and scientists like to upload their own videos.

Mendeley

Mendeley allows scientists to organize their papers in relation to research topics, and to collaborate other researchers. All papers can be stored as PDFs and the used across different media, (like your iPad, laptop, desktop, tablet). It automatically organizes papers, and allows groups to be created in order to share the papers.

Mekontosj

An alternative to Mendeley, without the social networking angle.

Protocolpedia

Focuses on scientific protocols. An all user submitted site, which allows for multiple format submissions (including video).

This feature was based on, and edited, from the Science Advisory Board.

Posted by: Dr. Tim Sandle

Pomegrantes and superbugs

timsandle@btinternet.com (Tim Sandle) — Mon, 23 Jan 2012 09:00:06 PST

Extracts from fruit may act as a potential new weapon in the fight against hospital superbugs like MRSA. Scientists at the University of Kingston, in Surrey, have shown that pomegranate can be used to create an ointment with the power to tackle the drug-resistant infections.

The researchers, led by Professor Naughton, have found that mixing the fruit's rind with two other natural products – metal salts and vitamin C – greatly enhanced its infection-fighting properties. The discovery could pave the way for a lotion to be developed for patients or perhaps, in time, a new antibiotic.

The research was published in:

Anti-microbial pomegranate rind extracts: enhancement by Cu(II) and vitamin C combinations against clinical isolates of Pseudomonas aeruginosa" by Simon W J Gould, Mark D Fielder, Alison F Kelly, Waffa El Sankary, Declan Naughton. British Journal of Biomedical Science. (2009) 66, 129-132.

The abstract to the article reads:

"Recently, natural products have been further evaluated as sources of antimicrobial agents with efficacies against a variety of microorganisms. This study reports the antimicrobial activities of pomegranate rind extract (PRE) in combination with Fe(II) and Cu(II) salts against extended-spectrum multidrug-resistant Pseudomonas aeruginosa. Antimicrobial suspension assays were carried out using aqueous extract of pomegranate alone or in combination with metals salts against P. aeruginosa. The extract:metal salt combination was also enhanced with the addition of vitamin C. Marked activities were observed for the aqueous PRE/Cu(II) preparations, which were greatly enhanced by the addition of the reductant vitamin C. In contrast, the aqueous PRE/Fe(II) preparations were inactive, regardless of addition of vitamin C. The combination of PRE and Cu(II) salts and vitamin C showed the greatest activity against clinical isolates of P. aeruginosa. These results warrant further investigation of PRE as a potential source of new antimicrobial agents."

Will this lead to a new development?

Posted by: Dr. Tim Sandle

PMF newsletter includes European GMP update

timsandle@btinternet.com (Tim Sandle) — Mon, 23 Jan 2012 12:50:27 PST

The latest issues of the essential Pharmaceutical Microbiology Forum Newsletter has been issued (Vol. 18, No.1). In the newsletter there is a review of the use of wildtype / environmental isolates by Bob Westney and a review of recent European regulations, with a particular focus on microbiology, by Tim Sandle.

The introduction to the regulatory review reads:

"This paper surveys some of the recent developments in European Regulatory Requirements that have taken place in 2011. By ‘regulatory developments’ I am referring to the wider definition in terms of pharmacopoeial changes and inspectorate guidelines. Reference is also made to documents issued by influential organisations like the World Health Organisation. The review of regulatory changes is divided into different sections, depending upon the body which issued the change or proposed change."

The PMF newsletter can be viewed here: PMF 18:1

Posted by: Dr. Tim Sandle

Falsified medicinal products

timsandle@btinternet.com (Tim Sandle) — Mon, 23 Jan 2012 06:30:00 PST

The European Medicines Agency (EMA) has responded positively to a new directive published in the Official Journal of the European Union addressing concerns over increases in falsified medicines in the supply chain. The directive became effective during 2011, and EMA is working closely with its partners and the European Commission (EC) on implementation during 2012 and all member states will have to begin applying the measures beginning January 2013.

First of all, the new directive properly defines "falsified medicinal products" to distinguish them from other illegal medicinal products or from those that infringe on intellectual property rights. It also notes that medicinal products with unintentional quality defects should not be confused with falsified medicinal products. A falsified medicinal product is now defined as any medicinal product with a false representation of:

its identity, including its packaging and labelling, its name, or its composition as regards to any of the ingredients including excipients and the strength of those ingredients
its source, including its manufacturer, its country of manufacturing, its country of origin, or its marketing authorization holder
its history, including the records, and documents relating to the distribution channels used.

A primary focus is on the increasing complexity of the supply chain. Legislation is extended for nontraditional distribution network participants, such as brokers, who are not considered wholesale distributors and so previously were unaccountable. To ensure transparency, a database of wholesale distributors, which have passed member state-inspection, should be established at the European Union (EU) level.

Posted by: Dr. Tim Sandle

Controversial airborne bird flu research postponed

timsandle@btinternet.com (Tim Sandle) — Sun, 22 Jan 2012 05:16:13 PST

As was widely reported in the general media and scientific press (such as American Scientist), two scientific research teams based at Erasmus University in the Netherlands and the University of Wisconsin, Madison, managed to covert the bird flu virus (H5N1) into a form that can be transmitted through the air (based on a study conducted on ferrets, apparently a good model for predicting what flu viruses will do in people). The announcement about the results was made by the Dutch team. The New York Times noted the dangers when it stated that the scientists had taken one of the most dangerous flu viruses ever known and made it even more dangerous — by tweaking it genetically to make it more contagious."

Fox News reports that due to the controversy surrounding the research and due to the associated risks the research project has been suspended. Global Toronto adds further detail, indicating that the research has only been suspended for 60-days, pending a review. The idea is that the two months will the two months allow interested parties: governments, international organizations and the scientific community time to determine whether the research is worthwhile and if it can be conducted safely and securely.

Read more in a special report by Tim Sandle on the Digital Journal.

Posted by: Dr. Tim Sandle

Sterile product manufacture

timsandle@btinternet.com (Tim Sandle) — Sun, 22 Jan 2012 07:47:49 PST

PICS released a document PI 032-1 on 1 December 2009 GMP ANNEX 1 REVISION 2008, INTERPRETATION OF MOST IMPORTANT CHANGES FOR THE MANUFACTURE OF STERILE MEDICINAL PRODUCTS.

A blog reader (Dr. N. Halls) has sent in the following post.

With respect to sampling prior to final sterile filtration, the document provides quite good advice on sampling before sterile filtration that says that sampling should take place "prior to the last filtration step, if technically possible". With respect to redundant sterile filtration, the document says that "sampling should be performed upstream of these filters in order not to compromise the filtration step."

Part of the comments from Dr Halls raise one of the issues with validation and that is the reference to "filters "in series". From a filtration perspective redundant filtration is an subset of filtration "in series". If a system is referred to as one "in series", then the first filter could be a bioburden reduction filter and the second filter would be the sterilising filter. In a redundant filtration system EITHER of the filters in series is the sterilizing filter.

PDA Technical Report 26 "Sterilizing Filtration of Liquids" has good advice on both nomenclature and integrity testing / operational issues. The filter that is the closest to the point of use is the primary filter and the filter that is there as a backup is called the secondary filter.

Posted by: Dr. Tim Sandle

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Mon, 05 Sep 2011 00:00:00 PDT

Pharmaceutical Microbiology: Is an edible vaccine in our near future?
Immunizations taken with food? Sounds more pleasant than a jab in the arm, but could it be a reality? Scientists in Australia are getting ever closer to this revolutionary method that could protect people from many common diseases without the trauma and at a fraction of the cost.
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Gordon Brown's final years leading the Labour government were permanently in "chaos and crisis", says former chancellor Alistair Darling in his memoirs.