Improving sanitation

The United Nations (UN) has called on countries to “radically” increase investments in water and sanitation infrastructure, not only to protect their populations from deadly diseases but also to ensure that they are able to achieve the Sustainable Development Goals (SDGs). Goal 6 of the SDGs aims to “ensure availability and sustainable management of water and sanitation for all”. It is a comprehensive goal that addresses the entire water cycle, from access to use and efficiency, to the integrated management of water resources and water-related ecosystems.

Coinciding with the start of the United Nations International Decade for Action – “Water for Sustainable Development” (2018-2028), the current edition of ISO focus asked industry experts for their perspective on these issues and what needs to be done to tackle the toilet problem and ensure that going to the toilet is safe and sanitary – with help from the future standard ISO 30500.

See: ISO

Posted by Dr. Tim Sandle

New edition of ISO/IEC 17025

News in from the International Standards Organization: ISO/IEC 17025: 2017 has is available.

ISO/IEC 17025:2017, General requirements for the competence of testing and calibration laboratories, is the international reference for laboratories carrying out calibration and testing activities around the world.

Producing valid results that are widely trusted is at the heart of laboratory activities. ISO/IEC 17025:2017 allows laboratories to implement a sound quality system and demonstrate that they are technically competent and able to produce valid and reliable results.

ISO/IEC 17025 also helps facilitate cooperation between laboratories and other bodies by generating wider acceptance of results between countries. Test reports and certificates can be accepted from one country to another without the need for further testing, which, in turn, improves international trade.

In order to reflect the latest changes in market conditions and technology, the new edition of the standard encompasses the activities and new ways of working of laboratories today. It covers technical changes, vocabulary and developments in IT techniques and takes into consideration the latest version of ISO 9001 on quality management.

What are the main changes in the 2017 version?

• The scope has been revised to cover testing, calibration and sampling associated with subsequent calibration and testing.
• The process approach now matches that of newer standards such as ISO 9001 (quality management), ISO 15189 (quality of medical laboratories) and ISO/IEC 17021-1 (requirements for audit and certification bodies).
• The standard has now a stronger focus on information technologies and incorporates the use of computer systems, electronic records and the production of electronic results and reports.
• A new chapter introduces the concept of risk-based thinking.

See: ISO

   Posted by Dr. Tim Sandle

New EudraVigilance system

A new version of EudroVigillance, the European information system of suspected adverse reactions to medicines that are authorized or being studied in clinical trials in the European Economic Area (EEA) is available.

The new system makes it easier for marketing authorization holders and sponsors of clinical trials to report suspected adverse reactions and allows for better analysis of this information for the benefit of patient safety in Europe.

See: EudroVigillance

Posted by Dr. Tim Sandle

Microbes on the skin promote tissue healing and immunity

Beneficial bacteria on the skin of lab mice work with the animals' immune systems to defend against disease-causing microbes and accelerate wound healing, according to new research. Researchers say untangling similar mechanisms in humans may improve approaches to managing skin wounds and treating other damaged tissues.

Like humans and other mammals, mice are inhabited by large, diverse microbial populations collectively called the microbiome. While the microbiome is believed to have many beneficial functions across several organ systems, little is known about how the immune system responds to these harmless bacteria.

To investigate, NIAID scientists led by Yasmine Belkaid, Ph.D., chief of the Mucosal Immunology Section of NIAID's Laboratory of Parasitic Diseases, observed the reaction of mouse immune cells to Staphylococcus epidermidis, a bacterium regularly found on human skin that does not normally cause disease. To their surprise, immune cells recognized S. epidermidis using evolutionarily ancient molecules called non-classical MHC molecules, which led to the production of unusual T cells with genes associated with tissue healing and antimicrobial defense. In contrast, immune cells recognize disease-causing bacteria with classical MHC molecules, which lead to the production of T cells that stoke inflammation.

Researchers then took skin biopsies from two groups of mice -- one group that had been colonized by S. epidermidis and another that had not. Over five days, the group that had been exposed to the beneficial bacteria experienced more tissue repair at the wound site and less evidence of inflammation. Dr. Belkaid's team plans to next probe whether non-classical MHC molecules recognize friendly microbes on the skin of other mammals, including humans, and similarly benefit tissue repair. Eventually, mimicking the processes initiated by the microbiome may allow clinicians to accelerate wound healing and prevent dangerous infections, the researchers note.

See:

Jonathan L. Linehan, Oliver J. Harrison, Seong-Ji Han, Allyson L. Byrd, Ivan Vujkovic-Cvijin, Alejandro V. Villarino, Shurjo K. Sen, Jahangheer Shaik, Margery Smelkinson, Samira Tamoutounour, Nicholas Collins, Nicolas Bouladoux, Amiran Dzutsev, Stephan P. Rosshart, Jesse H. Arbuckle, Chyung-Ru Wang, Thomas M. Kristie, Barbara Rehermann, Giorgio Trinchieri, Jason M. Brenchley, John J. O’Shea, Yasmine Belkaid. Non-classical Immunity Controls Microbiota Impact on Skin Immunity and Tissue Repair. Cell, 2018; DOI: 10.1016/j.cell.2017.12.033

Posted by Dr. Tim Sandle

First stem cells created using CRISPR genome activation

Researchers have turned skin cells from mice into stem cells by activating a specific gene in the cells using CRISPR technology. The innovative approach offers a potentially simpler technique to produce the valuable cell type and provides important insights into the cellular reprogramming process.

Pluripotent stem cells can be turned into virtually any cell type in the body. As a result, they are a key therapeutic resource for currently incurable conditions, such as heart failure, Parkinson's disease, and blindness. They also provide excellent models to study diseases and important tools to test new drugs in human cells.

In 2006, Gladstone Senior Investigator Shinya Yamanaka, MD, PhD, discovered he could make stem cells -- dubbed induced pluripotent stem cells (iPSCs) -- by treating ordinary skin cells with four key proteins. These proteins, called transcription factors, work by changing which genes are expressed in the cell, turning off genes associated with skin cells and turning on genes associated with stem cells.

Building on this work, Dr. Sheng Ding and others previously created iPSCs not with transcription factors, but by adding a cocktail of chemicals to the cells. The latest study, published in Cell Stem Cell, offers a third way to turn skin cells into stem cells by directly manipulating the cells' genome using CRISPR gene regulation techniques.

See:

Peng Liu, Meng Chen, Yanxia Liu, Lei S. Qi, Sheng Ding. CRISPR-Based Chromatin Remodeling of the Endogenous Oct4 or Sox2 Locus Enables Reprogramming to Pluripotency. Cell Stem Cell, 2018; DOI: 10.1016/j.stem.2017.12.001

Posted by Dr. Tim Sandle

MHRA on Brexit

MHRA update to pharmaceutical companies on exit preparations. MHRA is aware that companies who market pharmaceuticals in the EU and UK will need to plan and make decisions in advance of the UK’s departure from the EU in March 2019.

The UK’s intention remains to secure an implementation period based on the existing structure of EU rules and regulations as quickly as possible, and to agree a deep and special future partnership. MHRA will continue to advise businesses on the basis of the UK position and will continue to work with the EMA in planning for the UK’s withdrawal from the EU and future relationship.

Companies have been asking for detail about UK legislative requirements in different scenarios. MHRA has been working closely with industry associations and other stakeholders and further details on all these issues and more – both Day One and longerterm proposals – will be published when appropriate.

The UK intends to agree a time-limited implementation period with the EU, and both parties have recognised its importance. Should however there be no implementation period,

MHRA’s approach would be in line with the following principles:

The European Union (Withdrawal) Bill will convert the existing EU legislative framework into UK law at the moment of exit, so there would be no sudden changes to the UK regulatory framework.

MHRA would be pragmatic in establishing UK regulatory requirements. We would give adequate notice and ensure that companies had sufficient time to implement any changed requirements.

Where possible, MHRA would be making use of the information it already has to complete administrative tasks for continuity of work and licences.

MHRA would ensure the minimum disruption and burden on companies as the UK exits the EU, while building on the existing relationship between MHRA and firms.

See: https://www.gov.uk/government/news/mhra-update-to-pharmaceutical-companies-on-exit-preparations

Posted by Dr. Tim Sandle

Monoclonal antibody therapies for veterinary use

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Veterinary Use (CVMP) has approved the first ever guidance at European Union (EU) level for monoclonal antibody therapies for veterinary use. The guidance was prepared by the CVMP’s Ad Hoc Expert Group on Veterinary Novel Therapies (ADVENT) in the form of a question-and-answer document.

The guidance relates to particularities of monoclonal antibodies for veterinary use, quality control for potential contaminants, stability testing, reproductive safety studies and data to address potential for indirect adverse effects.

Monoclonal antibodies are immune proteins that recognise and bind to a specific target protein, and have not been used in veterinary medicines until recently. In human medicine, these therapies have been authorised for many years for use against cancer and diseases affecting the immune system, such as rheumatoid arthritis. Therapies that are new to veterinary medicine face particular challenges due to a lack of regulatory guidance.

To access the guidance, see EMA.

Posted by Dr. Tim Sandle

Annual report of the Good Manufacturing and Distribution Practice Inspectors Working Group

A new document from the European Medicines Agency.

The document is the annual report of the GMP/GDP Inspectors Working Group (GMDP IWG) for the year 2016. This group was established at EMA in 1996.

The GMDP IWG provides input and recommendations on all matters relating directly or indirectly to Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP).

The GMDP IWG focuses on harmonisation and co-ordination of GMP and GDP related activities at EU level. The group's role and activities are described in more detail in its mandate, which was revised in 2013.

This annual report is set out in line with the format and objectives of the 2016 work plan.

To access the document, see EMA.



Posted by Dr. Tim Sandle

Ocean Transport is Gaining Momentum in Pharmaceutical Logistics

One of the biggest challenges in the pharmaceutical industry has nothing to do with the drugs themselves — it’s in getting the drugs, medications and equipment from their factories to hospitals and pharmacies around the world in a timely and cost-effective manner. Trucks work for domestic transportation but run into trouble when it comes to international transport. Planes can easily cross oceans, but the cost of loading up a cargo plane with pharmaceuticals is astronomical — a cost that is often passed along to the consumer.

A special report by Megan Ray Nichols
For these reasons, ocean transportation is growing in popularity among pharmaceutical companies around the globe. What are the pros and cons of ocean transport, and is it something that you should consider for your own logistical needs?

The Speed of Ocean Transit

One of the things that has discouraged pharmaceutical companies from utilizing ocean transport in the past is the fact that it takes a while for a cargo ship to traverse the oceans between destinations. Items that required refrigeration often couldn’t be transported by sea because of a lack of refrigeration technology in the enormous cargo containers.

While speed hasn’t changed in recent years, storage technology has advanced dramatically. Specifically, it has become easier to obtain the equipment needed to create refrigerated cargo containers, allowing even temperature-sensitive pharmaceuticals to be shipped by sea without impacting the efficacy of the products.

Changes in shipping technology have enabled more and more companies to shift their shipping logistics from air to sea transport while maintaining their timelines.

Changes in Packaging and Shipping

Potential exposure to sea water and salt air is necessitating one major change — a shift from traditional wooden pallets to plastic ones.

Wooden pallets are probably the most common type of pallet used for shipping pharmaceuticals, foodstuffs and the majority of other products packed and shipped around the world. They’re popular because they’re cheap and sturdy, and they can be recycled when they start to break down. Add sea air and salt water to the mix, and these wooden pallets can become a liability, potentially breaking down faster. In addition, the humid air can encourage mold or mildew growth on the pallets themselves, creating a potential for contamination.

In the United States alone, more than two billion pallets are used every day to transport goods — and between 90 and 95 percent of them are made of wood. It stands to reason that the majority of pallets being used to ship pharmaceuticals are likely wood. If sea transit becomes the norm for pharmaceutical shipment, the use of wooden pallets could become a problem. Transitioning to molded plastic pallets, which are resistant to both weather and mold/mildew growth could help prevent this issue before it has a chance to manifest.

The Problem of Security

The pharmaceutical industry is a massive one — it’s estimated that pharmaceuticals alone make up more than $1.1 trillion in the world economy, with the number expected to grow by 2020 by 41 percent. It makes sense that this multi-billion dollar industry could potentially become the target for thieves and pirates.

Cargo theft is not a new concept — as long as there has been cargo to be transported, there have been people trying to steal it. In the past, it was on horseback and from the decks of pirate ships. Today, it’s in cars…and on the decks of more advanced pirate ships.

Keeping cargo manifests and shipping schedules secure for sea transport can help to reduce the chance of theft on the high seas, but it’s not a perfect solution. High tech solutions, such as biometric locks on shipping containers, can help make your shipments less desirable. While they can be circumvented, it takes a lot of extra steps, and it’s often not worth the effort to the potential thieves.

Tracking your shipments with technology can also help you thwart potential crime, either by discouraging thieves from committing their crime in the first place or allowing you to recover stolen goods.

Taking to the high seas isn’t just for pirates anymore. It is a fantastic way to reduce costs and keep up with your deadlines while ensuring that your products are delivered to the places that need them most.

Validation Requirements for Gaseous Sterilization Using Ethylene Oxide

Gaseous sterilization is long-established but it is increasingly being reassessed and adopted due to the growth in the markets for medical devices and for single-use sterile disposable technologies for pharmaceuticals. Gaseous sterilization is not an exact term and there are different types of gaseous sterilization (and a further distinction between gases and vapors). The first division is with the agents and here sterilizing gases include: formaldehyde, ethylene oxide, propylene oxide, ozone, and chlorine dioxide. A second division is with vapors, such as peracetic acid and hydrogen peroxide. In drawing out the gas-vapor distinction, a gas is a substance that has a single defined thermodynamic state at room temperature; in contrast, a vapor is a substance that is a mixture of two phases at room temperature, namely gaseous and liquid phase.

A new article of interest.

Of these sterilants, the most commonly applied substances to sterile manufacturing are ethylene oxide and vapor phase Hydrogen peroxide. Ethylene oxide is used to sterilize many plastics; vapor phase hydrogen peroxide is typically used to decontaminate barrier systems (such as isolators).  

In relation to sterilization, gases are more penetrating, more uniform in concentration and less subject to variations in temperature and relative humidity than vapors. In contrast, vapors have different concentrations in each phase. Furthermore, the kill rates in the gas and liquid phase appear to be substantially different reflecting the different concentrations and available water in each phase. Thus, conventionally, gas and vapor are considered to be separate sterilization processes.in a separate chapter (gaseous sterilization is distinct from vapor sterilization because with gas, the condensation of the agent is not a consideration in the execution of these processes).

Reference:

Sandle, T. (2017) Validation Requirements for Gaseous Sterilization Using Ethylene Oxide, Journal of Validation Technology, 23 (5): 1-10

See: http://www.ivtnetwork.com/article/validation-requirements-gaseous-sterilization-using-ethylene-oxide

Posted by Dr. Tim Sandle

Pharmaceutical Microbiology - Provides Remedial Ways to Help People

Microbiology is commonly known as the study of those organisms that cannot be seen with the naked eyes. Such organisms are termed as microorganisms as they are too small to be seen. Some of the very famous examples of microorganisms are Fungus, protists, and prokaryotes. Viruses normally are not properly known as living beings; however, they are also tested properly when it comes to microbiology. In reality, microbiology is actually a wide thing encircling virology, parasitology, bacteriology, over and above usually comprise of the investigation into the body's defense system or just immunology.

Guest post by Dr. Amol Bamane

Pharmaceutical microbiology is a further extension of microbiology. Every hospital and research labs generally includes a medical microbiology division, where one can frequently find several sorts of clinical samples, for instance, swabs, feces, urine, blood, sputum, cerebrospinal fluid, synovial fluid, and contaminated tissues etc. over here the process primarily searches for alleged pathogens and considering them, together with estimating to find out whether your identified pathogen is absolutely extremely perceptive or resistant in front of an extremely suggested drug. The result is a report identifying the infection-causing microorganism along with the type and in addition to the number of drugs that have to be given to the affected individual.

Ever since the evolution of mankind, erectile dysfunction causes and symptoms have become an indispensable part of our lives. Health problems are on the rise and with it, the pharmaceutical business. Pharmaceutical companies provide drugs or medicines that are required for medical treatments. Earlier in India, these medicines were provided by various multinational companies. However, this monopoly ended with the Indian pharmaceutical industry taking a revolutionary turn in the 1970s with the enactment of the Indian Patent Act that allowed local development of pharmaceutical industry.

The microbiology laboratory in any of the hospitals or clinics may probably also come across parasitic living beings as well as viruses. Work related to blood is frequently furthermore carried out in the laboratories, where, utilizing entire blood samples, entire blood calculations in addition to blood evaluations are completed and the conclusion is drawn based on all such things. On event, blood specimens likely to be citrated to evaluate blood clotting moments as well as coagulation factors.

• Sub-divisions of Microbiology:
• Microbiology is divided into many sub-disciplines as follows.
• Cellular microbiology (combination of microbiology and cell biology)
• Medical microbiology (study of pathogenic microbes related to diseases)
• Environmental microbiology (study of function of microbes in natural environments)
• Veterinary microbiology (study of microbes in veterinary medicines)
• Evolutionary microbiology (study of evolution of microbes)
• Industrial Microbiology ( usage of microbes for industrial purposes)

Apart from these, there are many other fields of microbial physiology, aero microbiology, microbial genetics, food microbiology, agricultural microbiology and many sub-disciplines as well.

Benefits of Microbiology:

No doubt microbes are related to human illnesses, but there are many microbes which are advantageous to human beings. Industrial fermentation which involves the production of alcohol, dairy products, and vinegar is one of the most popular ways wherein microbes are utilized. The antibiotic production also involves microbes.

Scientists and researchers have been able to produce enzymes for their usage in genetic systems. Enzymes which are biotechnologically important include Taq polymerase and even reporter genes. Microorganisms produce biopolymers which are extensively used. Microorganisms are also used for erectile dysfunction cure and medicine.

With only 1 percent of all microbes' related species being studied, the scope of microbiology is huge and its study and research are leading the field to new horizons.

Pharmaceutical Microbiology contains numerous important purposes, that are not only restricted to the hospitals but are also required in clinics. Nowadays one can easily search such associations that proffer erectile dysfunction treatment concerning remedial procedure to manufacture the product that fulfills all the fundamentals that also along with authenticated product or service assurance. Examinations cover facility validation, unprocessed materials examinations, sterilization and wrapping supports, biocompatibility, studies related to the devices that can be used again in addition to planned quality control evaluations. Such sort of tests will assist the producers of remedial mechanisms to administer to get their products to sell faster and reduce the risk.

A number of microbiologists are working in the medication industry. The medicines, other medical aids, and certain health supplements are manufactured and researched carefully in the concerned microbiology laboratories.

The businesses that are engaged in the business of supplying food include a group of microbiologists that are highly skilled and help the industry in proffering such product to the people that are properly made by adopting various quality control measures. The Foods product that will spoil speedily can be difficult to endorse, that is why microbiologists are usually there to provide the essential guidance in order to increase the production by good packaging techniques to reduce spoilage and also amplify freshness of the foodstuff.

How good bacteria control your genes

Scientists have discovered a way that bacteria in the gut can control genes in our cells. Their work shows that chemical messages from bacteria can alter chemical markers throughout the human genome. The signal chemicals are made when bacteria digest fruits and vegetables. By communicating in this way, the bacteria may help to fight infections and to prevent cancer.

This new research shows that the short chain fatty acids increase the number of chemical markers on our genes. These markers, called crotonylations, were only discovered recently and are a new addition to the chemical annotations in the genome that are collectively called epigenetic markers. The team showed that short chain fatty acids increase the number of crotonylations by shutting down a protein called HDAC2. Scientists think that changes in crotonylation can alter gene activity by turning genes on or off.

The team studied mice that had lost most of the bacteria in their gut and showed that their cells contained more of the HDAC2 protein than normal. Other research has shown that an increase in HDAC2 can be linked to an increased risk of colorectal cancer (here and here). This could mean that regulating crotonylation in the genome of gut cells is important for preventing cancer. It also highlights the important role of good bacteria and a healthy diet in this process.

See:

Rachel Fellows, Jérémy Denizot, Claudia Stellato, Alessandro Cuomo, Payal Jain, Elena Stoyanova, Szabina Balázsi, Zoltán Hajnády, Anke Liebert, Juri Kazakevych, Hector Blackburn, Renan Oliveira Corrêa, José Luís Fachi, Fabio Takeo Sato, Willian R. Ribeiro, Caroline Marcantonio Ferreira, Hélène Perée, Mariangela Spagnuolo, Raphaël Mattiuz, Csaba Matolcsi, Joana Guedes, Jonathan Clark, Marc Veldhoen, Tiziana Bonaldi, Marco Aurélio Ramirez Vinolo, Patrick Varga-Weisz. Microbiota derived short chain fatty acids promote histone crotonylation in the colon through histone deacetylases. Nature Communications, 2018; 9 (1) DOI: 10.1038/s41467-017-02651-5

Posted by Dr. Tim Sandle

Monocyte Activation Test (MAT) - The in vitro test for pyrogen detection – White paper

Monocyte Activation Test (MAT)

The in vitro test for pyrogen detection

Pyrogens…a hot story

Adverse reactions to parenteral preparations have been described as early as the late 19th century, frequently termed “injection fever”. The first fever causing agents, “pyrogens”, were identified in 1912 by Hort and Penfold, who were also the first to design a pyrogen test based on injection of material into rabbits. At that time, the pyrogenic agent was identified as endotoxins included in preparations of gram-negative bacteria. Interestingly, it was shown that live and dead microorganisms presented the same pyrogenic potential.

In the following years, it became more and more clear that sterility is not necessarily equal to apyrogenicity, which led to the inclusion of a pyrogen test in the 12th edition of the United States Pharmacopoeia (USP) in 1942.

Due to their stability, endotoxins can be very difficult to remove by classical bactericidal procedures such as heating or filtration. This made control of the whole production process necessary, especially for the water used, as this water was frequently found as source of pyrogenic contaminations.

The high number of pyrogen tests on rabbits and the variable sensitivity of that test system (e.g. by development of pyrogen tolerance in rabbits after repeated injections) made development of alternative tests necessary. The first and most successful of these new tests was the bacterial endotoxin test based on the lysate of amoebocytes from the blood of horseshoe crabs, which became commercially available in the 1970s and has been widely used as a replacement for the rabbit pyrogen test.

Today's qualified water systems no longer present such a high risk of endotoxin contamination, with more than 99% of our tests for various production sites showing contamination of much less than the specification of 0.25 EU/mL.

On the other hand, quality control for the presence of pyrogens is getting more and more complicated, as production processes (e.g. biotechnology and cell therapy products) bring new risks of various contaminants (i.e Non-Endotoxin Pyrogens) entering the final product, like viruses from animal-based raw materials or gram-negative bacteria from contaminations. Non-Endotoxin Pyrogens (NEPs) are undetectable by the bacterial endotoxin test,

and there is therefore a risk of overlooking a NEP contamination.

In 2016, due to the increase in production of more and more complex products, the general chapter for bacterial endotoxins testing in the European Pharmacopoeia (chapter 5.1.10) introduced the necessity for an evaluation of the product, production process and raw materials with respect to the risk for pyrogens that are non-detectable by the bacterial endotoxin test (ie Non-Endotoxin Pyrogens).

In this context, the in vitro pyrogen test based on human cells offers a valuable alternative to the rabbit pyrogen test. Since2010, the Monocyte Activation Test has been described as a compendial method for Pyrogen Detection in the European Pharmacopeia (chapter 2.6.30).

Test comparison

Both RPT and LAL tests are animal-based methods. LAL cannot can adequately detect the full spectrum of Pyrogens. Moreover, such tests cannot be used on several pharmaceutical products or for the testing of solid materials such as medical devices.

Click here to download our 12-page White paper.

White-nose syndrome fungus may have an Achilles' heel

In the course of genomic analyses of the fungus behind white-nose-syndrome, a devastating disease that has killed millions of bats in North America, US Forest Service scientists discovered something very surprising: brief exposure to UV-light kills Pseudogymnoascus destructans.

In the course of genomic analyses of P. destructans, a team of scientists from the U.S. Forest Service, U.S. Department of Agriculture and the University of New Hampshire found that the fungus is highly sensitive to UV light. P. destructans can only infect bats during hibernation because it has a strict temperature growth range of about 39-68 degrees Fahrenheit. However, treating bats for the disease during hibernation is challenging, so any weakness of the fungus may be good news to managers trying to develop treatment strategies.

In a study published on Jan. 2 in the journal Nature Communications titled "Extreme sensitivity to ultra-violet light in the fungal pathogen causing white-nose syndrome of bats," the research team suggests that P. destructans is likely a true fungal pathogen of bats that evolved alongside bat species in Europe and Asia for millions of years, allowing Eurasian bats to develop defenses against it. In the course of comparing P. destructans to six closely related non-pathogenic fungi, researchers discovered that P. destructans is unable to repair DNA damage caused by UV light, which could lead to novel treatments for the disease. The study was funded by the U.S. Fish and Wildlife Service.

See:

Jonathan M. Palmer, Kevin P. Drees, Jeffrey T. Foster, Daniel L. Lindner. Extreme sensitivity to ultraviolet light in the fungal pathogen causing white-nose syndrome of bats. Nature Communications, 2018; 9 (1) DOI: 10.1038/s41467-017-02441-z

Posted by Dr. Tim Sandle

Pharmig News #70

The 70^th edition of Pharmig News has been published.

In the new issue:

• Report from the Royal Society of Microbiology, by Julie Roberts.
• Report of the Pharmig 25^th Anniversary Conference, including reviews of the different presentations.
• Hot topics in pharmaceutical microbiology.
• Review of Pharmig’s Adriatic Region conference.
• Pharmig’s round-up of regulatory news.
• And more….

Copies have been sent to Pharmig member companies. If you are interested in reading a copy or finding out more about Pharmig, please contact Pharmig at: info@pharmig.org.uk

Posted by Dr. Tim Sandle

Revisions made to European Pharmacopoeia sterilisation chapters

Methods of sterilisation and the assessment of sterilisation using biological indicators represent important areas of regulatory concern. The two applicable guidance chapters in the European Pharmacopeia have undergone revisions. This article assesses the main changes. Notably these include reference to the production of sterile products through aseptic processing for the first time; and changes to the assessment of the suitability of biological indicators, including a new recommendation for supplier auditing.

Tim Sandle has written a new article for Clean Air and Containment Review. The reference is:

Sandle, T. (2017) Revisions made to European Pharmacopoeia sterilisation chapters, Clean Air and Containment Review, Issue 32, pp18-20

Posted by Dr. Tim Sandle

'Forgotten' antibiotic offers hope against superbugs

An antibiotic overlooked since its discovery 40 years ago could help develop new drugs against life-threatening infections caused by some of the world's most dangerous superbugs.

University of Queensland Institute for Molecular Bioscience (IMB) researchers synthesised the antibiotic, and increased its effectiveness against extensively drug-resistant bacteria, then collaborated with Monash University to evaluate the drug using animal models of infection.

Professor Matt Cooper, Director of IMB's Centre for Superbug Solutions, said the study was prompted by the urgent need for new drugs to counter widespread resistance to last-resort treatments.

"Octapeptins were discovered in the late 1970s but were not selected for development at the time, as there was an abundance of new antibiotics with thousands of people working in antibiotic research and development," Professor Cooper said.

"Given the very few researchers left in this field now, and the sparse pipeline for new antibiotics, we've used modern drug discovery procedures to re-evaluate its effectiveness against superbugs."

Professor Cooper said there were no new classes of antibiotics available for Gram-negative bacteria, with increasing incidence of extensive drug resistance around the world.

See:

Tony Velkov, Alejandra Gallardo-Godoy, James D. Swarbrick et al Structure, Function, and Biosynthetic Origin of Octapeptin Antibiotics Active against Extensively Drug-Resistant Gram-Negative Bacteria. Cell Chemical Biology, 2018; DOI: 10.1016/j.chembiol.2018.01.005



Posted by Dr. Tim Sandle