Saturday, 29 February 2020

Changes to ISO 14644-3:2019


ISO 14644-3:2019 is the second edition of the standard devoted to cleanroom and associated controlled environment tests, and it revises the 2005 version of the same international standard. Notably, Clause B.7, “Installed filter system leakage test,” was simplified, as there previously were concerns over its complexity. Furthermore, all guidance concerning classification of air cleanliness by airborne particle concentration that was found in the 2005 edition of ISO 14644 has been reserved for ISO 14644-1.


See: https://shop.bsigroup.com/ProductDetail/?pid=000000000030326494

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

Friday, 28 February 2020

Living building materials with bacteria


University of Colorado Boulder researchers have developed a new approach to designing more sustainable buildings with help from some of the tiniest contractors out there.

Such structures could, one day, heal their own cracks, suck up dangerous toxins from the air or even glow on command, based on experiments with cyanobacteria belonging to the genus Synechococcus. Under the right conditions, these green microbes absorb carbon dioxide gas to help them grow and make calcium carbonate -- the main ingredient in limestone and, it turns out, cement.

To begin the manufacturing process, the researchers inoculate colonies of cyanobacteria into a solution of sand and gelatin. With the right tweaks, the calcium carbonate churned out by the microbes mineralize the gelatin which binds together the sand -- and, which can then produce a brick.

Such bricks would actually remove carbon dioxide from the air, not pump it back out. In the new study, the team discovered that under a range of humidity conditions, they have about the same strength as the mortar used by contractors today.

The researchers also discovered that they could make their material reproduce. Chop one of these bricks in half, and each of half is capable of growing into a new brick. Those new bricks are resilient: According to the group's calculations, roughly 9-14% of the bacterial colonies in their materials were still alive after 30 days and three different generations in brick form. Bacteria added to concrete to develop self-healing materials, in contrast, tend to have survival rates of less than 1%.


See:

Chelsea M. Heveran, Sarah L. Williams, Jishen Qiu, Juliana Artier, Mija H. Hubler, Sherri M. Cook, Jeffrey C. Cameron, Wil V. Srubar. Biomineralization and Successive Regeneration of Engineered Living Building Materials. Matter, 2020; DOI: 10.1016/j.matt.2019.11.016

 Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

Thursday, 27 February 2020

Taming electrons with bacteria parts


Electrons are tough to pin down in biology. Learning how to harness electrons is no fool's errand because, when electrons move, they are the electricity that powers life.

Electrons power the production of fuel and medicine. Electron movement is behind photosynthesis, our main source of food and combustion. Moving electrons are the definition of an electric current, which is why you can read this story.

In a new study, scientists at the MSU-DOE Plant Research Laboratory report a new synthetic system that could guide electron transfer over long distances. The new system is made up of two components plucked from nature. One is a protein from bacteria and the other a molecule found in our blood.

Nature has figured out how to tame electrons. The trick is to split up their journeys into short pit stops that are easier to manage. Electrons then hop between stops as they are guided towards some final destination.

One of these natural pit stops is the heme, a molecule that contains iron. It is what gives our blood its color and it is found in many other biological molecules.

"In nature, multiple hemes have to be closely positioned and angled precisely to allow for fast electron hops. The hemes are fixed in place by attaching to protein structures," said Jingcheng Huang, a former graduate student in the lab of Danny Ducat. "Otherwise, if the distances between hemes become too large, an electron will hop out of control. It is lost."

Since hemes are found in almost all living beings, they can associate with many types of proteins. The science team used the protein BMC-H, from bacteria, to build their artificial electron pit stops.

The team identified four possible locations the heme can dock into. Specifically, the alpha helical region was the most promising host area.

"We didn't have to modify the BMC-H protein much," Huang said. "With only three amino acid substitutions, we can get a heme binding tightly to it. Because the modification is minimal, the protein's shape and functions remain intact."

The scientists have managed to produce these larger structures with hemes attached to them. Moreover, they can produce them inside of bacteria cells, which saves resources.

"We'd like to optimize this system into a functional nanowire," Huang said. "Someday, it could funnel electrons to power the production of new medicines, or biofuels or electronic devices made of biogoo; the possibilities are endless."

"The exciting part is that we played with what nature has already figured out: We took a protein that self-assembles into large structures but doesn't bind hemes and functionalized it so that it hosts them," Huang said. "Otherwise, if we had created a system from scratch, we would have added extra layers of difficulty. That's the essence of synthetic biology, taking natural ingredients and re-configuring them in new, unseen ways."
Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

Wednesday, 26 February 2020

Sticky antibiotic provides glue for successful treatment


Researchers have found how an antibiotic used to treat a debilitating gut infection stays put inside the body giving it time to effectively treat the problem, a discovery that will pave the way for the development of more effective antibiotic treatments to fight superbugs.

PE (pseudomembranous colitis) is a debilitating inflammation of the colon caused by infection with the microbe Clostridium difficile (and sometimes Staphylococcus aureus). The sugar- or carbohydrate-containing antibiotic known as vancomycin is taken by mouth to kill the infecting microbe.

To be effective, vancomycin needs to stay in the GI tract (gut) close to where it is needed and not be diluted away or lost through the lining of the gut and into the bloodstream. A multi-disciplinary team of scientists at the Universities of Nottingham and Leeds have now shown this 'staying put' mechanism is precisely what happens and that it can occur in an unexpected way.

Forming a formidable barrier

The research, published today in Scientific Reports shows that protein-carbohydrate molecules of the gut called mucins provide a formidable barrier helping to prevent the drug escaping using a unique mechanism of formation of large molecular complexes or clumps. The antibiotic and mucins join together to form a mucoadhesive complex, likely trapping the antibiotic within large complexes. It is the trapped vancomycin which the scientists believe may lead to delayed transit of the antibiotic leading to prolonged exposure of the antibiotic to the infectious C. difficile.

Dr Mary Phillips-Jones, Associate Professor in Polymer & Microbial Biophysics at the University of Nottingham led the research, she said: "Vancomycin is a precious 'last-line' antibiotic in the clinician's arsenal of therapies to fight several important pathogens including MRSA, pneumonia, as well as C. difficile. The clumping effect with gut mucins revealed in our study not only gives new information about what may happen when the antibiotic is given orally, but might also provide new insights into its behaviour when infused into patients suffering from other life-threatening infections."

The findings also fit with other studies which show that oral vancomycin produces high levels of vancomycin resistance amongst some gut bacteria (VRE), contributing to the generation of antimicrobial resistance (a serious concern); the clumping/ complexation phenomenon may therefore provide the first explanation of a mechanism by which this VRE generation occurs. But the benefits of taking oral vancomycin at the right time and when appropriate still outweigh any negative generation of antimicrobial resistance, and the study highlights that it is wise to take vancomycin when your GP advises it is good to do so.

Dr Stephen Harding, Professor of Applied Biochemistry at the University of Nottingham added: "The antibiotic vancomycin is a truly remarkable molecule -- a drug with its own mucoadhesive or sticky property which slows its transit through the gut right down giving maximum therapeutic effect and minimizing unused vancomycin being returned to the environment. If scientists are going to win the fight against anti-microbial resistance, joint institutional and interdisciplinary approaches like this successful one are going to prove crucial."

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

Tuesday, 25 February 2020

A new treatment strategy against MERS


    First identified in 2012, the MERS-coronavirus is capable of causing severe and often fatal pneumonia. There are no effective treatments for MERS. Researchers from the German Center for Infection Research (DZIF) at Charité -- Universitätsmedizin Berlin recently identified a cellular recycling process known as autophagy as a potential target in the fight against MERS. Autophagy-inducing substances -- including certain licensed drugs -- were shown to be capable of drastically reducing the rate at which the virus replicates.

    The MERS pathogen is capable of causing a flu-like illness (Middle East Respiratory Syndrome) which is often associated with pneumonia. Since its appearance in 2012, approximately 2,500 cases have been reported to the WHO across a total of 27 countries. Approximately one third of infections have resulted in death. A team co-led by PD Dr. Marcel Müller of the Institute of Virology on Campus Charité Mitte recently discovered that the MERS virus can only replicate efficiently if it inhibits a cellular process known as autophagy. Based on this initial discovery, the researchers went on to identify substances which are capable of inducing autophagy and can thus be used to limit viral infection.

    The term autophagy refers to a type of cellular recycling process which enables cells to dispose of damaged materials and waste products, while retaining intact components for incorporation into new cellular structures. This autophagic degradation, or 'auto-digestion', is also capable of identifying pathogen-derived components, such as the building blocks of viruses, which are treated as waste products and eliminated. A range of viruses are known to have developed strategies to dysregulate or inhibit autophagy. PD Dr. Müller and his colleagues therefore set out to determine whether the MERS virus is capable of modulating autophagic degradation. As a first step, and using stringent biosafety conditions, the researchers infected cells with the MERS virus. Subsequent observations revealed a disruption to the cellular recycling process in cells infected with the virus. "This result clearly indicated that the MERS pathogen benefits from an attenuation of the cellular recycling process," explains PD Dr. Müller.

    The researchers also succeeded in identifying a previously unknown molecular switch which regulates the process of autophagic degradation: the SKP2 protein. The researchers discovered that the MERS virus activates this molecular switch in order to slow down the cell's recycling processes and avoid degradation. Using these new insights, the researchers treated MERS-infected cells with various SKP2 inhibitors in order to stimulate the degradation process. This strategy proved successful, the autophagy-inhibiting substances reducing viral replication by a factor of 28,000. Among the substances used to elicit this effect were licensed drugs such as niclosamide, a treatment for tapeworms which had previously been identified as an SKP2 inhibitor. Importantly, niclosamide was shown to be capable of drastically reducing the replication of the MERS virus in cell culture.

    "Our results reveal SKP2 to be a promising starting point for the development of new substances capable of fighting the MERS virus, and potentially even other autophagy-dependent viruses," says PD Dr. Müller. SKP2 inhibitors do not target the virus directly. For this reason, the research group leader expects their use to be associated with a reduced risk of resistance. "However, SKP2 inhibitors will need to be tested in vivo before they can be used as drugs. Furthermore, one has to properly evaluate the risks and benefits for their in vivo use, since even drugs that have already been approved can have side effects," says the virologist. The researchers will also test whether SKP2 inhibitors could be effective against other coronaviruses such as SARS or the novel coronavirus (2019-nCoV) which is currently emerging in China.


    See:

    Nils C. Gassen, Daniela Niemeyer, Doreen Muth, Victor M. Corman, Silvia Martinelli, Alwine Gassen, Kathrin Hafner, Jan Papies, Kirstin Mösbauer, Andreas Zellner, Anthony S. Zannas, Alexander Herrmann, Florian Holsboer, Ruth Brack-Werner, Michael Boshart, Bertram Müller-Myhsok, Christian Drosten, Marcel A. Müller, Theo Rein. SKP2 attenuates autophagy through Beclin1-ubiquitination and its inhibition reduces MERS-Coronavirus infection. Nature Communications,2019; 10 (1) DOI: 10.1038/s41467-019-13659-4

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

Monday, 24 February 2020

Bacteria-shredding tech fights drug-resistant superbugs


Researchers have used liquid metals to develop new bacteria-destroying technology that could be the answer to the deadly problem of antibiotic resistance. The technology uses nano-sized particles of magnetic liquid metal to shred bacteria and bacterial biofilm -- the protective "house" that bacteria thrive in -- without harming good cells.

Antibiotic resistance is a major global health threat, causing at least 700,000 deaths a year. Without action, the death toll could rise to 10 million people a year by 2050, overtaking cancer as a cause of death.

When exposed to a low-intensity magnetic field, nano-sized droplets change shape and develop sharp edges When the droplets are placed in contact with a bacterial biofilm, their movements and nano-sharp edges break down the biofilm and physically rupture the bacterial cells.


In the new study, the scientists tested the effectiveness of the technology against two types of bacterial biofilms (Gram-positive and Gram-negative). After 90 minutes of exposure to the liquid metal nanoparticles, both biofilms were destroyed and 99% of the bacteria were dead. Importantly, laboratory tests showed the bacteria-destroying droplets did not affect human cells.

See:

Aaron Elbourne, Samuel Cheeseman, Paul Atkin, Nghia P. Truong, Nitu Syed, Ali Zavabeti, Md Mohiuddin, Dorna Esrafilzadeh, Daniel Cozzolino, Chris F. McConville, Michael D. Dickey, Russell J. Crawford, Kourosh Kalantar-Zadeh, James Chapman, Torben Daeneke, Vi Khanh Truong. Antibacterial Liquid Metals: Biofilm Treatment via Magnetic Activation. ACS Nano, 2020; DOI: 10.1021/acsnano.9b07861

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

Sunday, 23 February 2020

Role of Lactobacillus in Human Reproduction


The discovery of microbial communities inhabiting the whole female reproductive tract has challenged the traditional view of human fetal development in a sterile environment. Technical advances have facilitated the study of the bacterial microbiome in the upper and lower genital tract, as well as the role of such bacteria in women’s health and fertility.

Lactobacillus is a genus of Gram-positive, facultative anaerobic or microaerophilic, rod-shaped, non-spore-forming bacteria.

They are a major part of the lactic acid bacteria group (i.e., they convert sugars to lactic acid). In humans, they constitute a significant component of the microbiota at a number of body sites, such as the digestive system, urinary system, and genital system. In women of European ancestry, Lactobacillus species are normally a major part of the vaginal microbiota. Lactobacillus forms biofilms in the vaginal and gut microbiota, allowing them to persist during harsh environmental conditions and maintain ample populations. Lactobacillus exhibits a mutualistic relationship with the human body, as it protects the host against potential invasions by pathogens, and in turn, the host provides a source of nutrients. Lactobacillus is the most common probiotic found in food such as yogurt, and it is diverse in its application to maintain human well-being, as it can help treat diarrhea, vaginal infections, and skin disorders such as eczema.

The microbiota in the urogenital tract of healthy reproductive age women is mainly composed of bacteria from the Lactobacillus genus; however, structural or compositional variations of this microbiota, that could occur throughout a women’s life in response to intrinsic and extrinsic factors may impact the function of reproductive organs leading to infertility or other pathological conditions.

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

Saturday, 22 February 2020

Controlled phage therapy can target drug-resistant bacteria


Scientists are seeking alternatives to antibiotics, in a growing effort to head off the tide of incurable bacterial infections. In their work, the group has turned to bacteriophages, a naturally occurring group of viruses that colonize on bacteria.

By taking advantage of the bacteriophages' ability to home in on specific bacteria without damaging the rest of the microbiome, the researchers were able to use a combination of gold nanorods and near-infrared light to destroy even multidrug-resistant bacteria without antibiotics.

A bacteriophage, also known informally as a phage (/feɪdʒ/), is a virus that infects and replicates within bacteria and archaea. The term was derived from "bacteria" and the Greek φαγεῖν (phagein), meaning "to devour".


Among the unresolved issues of phage therapy is the incomplete characterization of the phages' biology -- a biology that could allow for unintended consequences due to the phages' own rapid evolution and reproduction, as well as potential toxins the viruses may carry. Another issue is the all-or-nothing aspect of phage therapy.

To surmount these challenges, a science team developed a method of controlled phage therapy using heat. The heat is enough to kill the bacteria, and it also kills the phages, preventing any unwanted further evolutions. The result is a guided missile of targeted phage therapy that also allows for dosage control.

See:

Huan Peng, Raymond E. Borg, Liam P. Dow, Beth L. Pruitt, Irene A. Chen. Controlled phage therapy by photothermal ablation of specific bacterial species using gold nanorods targeted by chimeric phages. Proceedings of the National Academy of Sciences, 2020; 201913234 DOI: 10.1073/pnas.1913234117

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

Friday, 21 February 2020

New strategy in the fight against antibiotic resistance


Bioscience engineers from KU Leuven in Belgium have developed a new antibacterial strategy that weakens bacteria by preventing them from cooperating. Unlike with antibiotics, there is no resistance to this strategy, because the non-resistant bacteria outnumber resistant ones.
Traditional antibiotics kill or reduce the activity of individual bacteria. Some bacteria become resistant to these antibiotics, allowing them to grow further and take over from non-resistant ones. The use of antibiotics therefore causes more and more bacteria to become resistant to antibiotics.

Bacteria, however, also exhibit group behaviour: for example, they can make a protective slime layer or biofilm that envelops their entire bacterial community. Dental plaque is an example of such a biofilm. Biofilms are often the source of bacterial infections. The social behaviour of bacteria is an interesting new target for antibacterial therapy.

The researchers showed that blocking slime production of salmonella bacteria weakens the bacterial community, making it easier to remove. They used a chemical, antibacterial substance that was previously developed at KU Leuven.

The scientists then compared the development of bacterial resistance to the new substance with that of classical antibiotics in a so-called evolution experiment. Evolution experiments are used to see how microorganisms adapt to a certain situation. "


There are several applications possible in agriculture, industry, and even our households. To this end, the researchers collaborate with experts in various applications, and with producers of animal feeds and cleaning products and disinfectants. The researchers are also investigating whether they can reproduce the phenomenon in other forms of microbial collaboration next to biofilms, and with other bacteria. 

See:

Lise Dieltjens, Kenny Appermans, Maries Lissens, Bram Lories, Wook Kim, Erik V. Van der Eycken, Kevin R. Foster, Hans P. Steenackers. Inhibiting bacterial cooperation is an evolutionarily robust anti-biofilm strategy. Nature Communications, 2020; 11 (1) DOI: 10.1038/s41467-019-13660-x

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

Thursday, 20 February 2020

Anticipating zoonotic virus outbreaks


The EU and Israeli Government (The Israeli Institute of Biological Research (IIBR))anticipated such Zoonotic Virus outbreaks and what they and we at Dyadic are doing to be better prepared for such pandemic and epidemics when they occur.

European Union Zoonotic Anticipation And Preparedness Initiative (ZAPI) Project,

The Problem Being Addressed:

Many infectious diseases, including influenza and Ebola, can be transmitted to humans from animals (and vice-versa). Known as zoonoses, these diseases represent a serious threat to both human and animal health.

The Solution Being Developed:

ZAPI brings together experts in human and animal health to create new platforms and technologies that will facilitate a fast, coordinated, and practical response to new infectious diseases as soon as they emerge.

Successful Developments

C1: How the C1 platform will change the production approach for recombinant vaccines

Expansion of ZAPI Program


Dyadic International, Inc. (Nasdaq:DYAI) received positive preliminary results from the ZAPI animal studies and expanded its research collaboration with ZAPI to express two additional proteins.

The C1 expressed ZAPI antigen was produced at 17 times the initial targeted expression level (1780 mg/l) and 35 times higher than the second-place cell line (insect cells/baculovirus) which failed to meet the ZAPI minimum required productivity level.

Animal studies with the C1 produced ZAPI antigen indicated that Dyadic\s C1 antigen demonstrated very strong performance in protecting both cattle and mice from the Schmallenberg virus (SBV).

As a result, ZAPI expanded the scope of Dyadic\s involvement in the program and Dyadic expects to receive additional funding from the ZAPI consortium in support of production of the two additional targets.

In addition to ZAPI Dyadic has collaborations with two of the top four animal health companies.

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

Wednesday, 19 February 2020

ISO 14971:2019 (medical devices)


The standard ISO 14971:2019 Medical devices — Application of risk management to medical devices has recently been issued.


ISO 14971, Medical devices – Application of risk management to medical devices, specifies the terminology, principles and process for managing the risks associated with medical devices, including software as a medical device (SaMD) and in vitro diagnostic (IVD) medical products.

The ISO standard promotes the safety of devices and equipment used for medical purposes. It covers the risks of injury related to the health of patients, the operator and other persons, as well as potential damage to property, equipment and the environment. The standard was updated to better align with changes in medical device regulations around the world.



Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

Tuesday, 18 February 2020

Whooping cough evolving into a superbug


Researchers have revealed the rise of evolving strains of the bacterium that causes whooping cough, a strain that is able to evade vaccine-generated immunity.


It appears the evolving strains make additional changes to better survive in their host, regardless of that person's vaccination status. The Australian researchers who ran the study also identified new antigens as potential vaccine targets.

See:

Laurence Don Wai Luu, Sophie Octavia, Chelsea Aitken, Ling Zhong, Mark J. Raftery, Vitali Sintchenko, Ruiting Lan. Surfaceome analysis of Australian epidemic Bordetella pertussis reveals potential vaccine antigens. Vaccine, 2020; 38 (3): 539 DOI: 10.1016/j.vaccine.2019.10.062

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

Monday, 17 February 2020

New development with antimicrobial dressings


Biomimetic hydrogels with "built-in" antimicrobial properties can significantly decrease the infection risks posed by wounds.

Hydrogels are molecule networks that hold water within their grid. Antimicrobial hydrogels can be produced by mixing with or attaching antimicrobial components to a polymer gel. Researchers at the Hebei University of Technology, Tianjin (China), Radboud University, Nijmegen (the Netherlands), and the University of Queensland, Brisbane (Australia) chose an alternative route and used photodynamic antimicrobial chemotherapy as their model. In this technique, photosensitizers enter an excited state when irradiated with light. Through a non-radiative transition, the photosensitizer enters a different, long-lived excited state. The transition can transfer energy to oxygen molecules, forming highly reactive oxygen species that kill microbes.

To date, synthetic gels with photodynamic antimicrobial activity have been neither biocompatible nor biodegradable. Products from biological sources, in contrast, harbor the risk of contamination or immune reactions and deliver results that are difficult to reproduce.

The team overcame this challenge by using fully synthetic hydrogels with biomimetic properties, which are properties that mimic biological systems. They selected a polymer with a helical backbone (polyisocyanide with grafted ethylene glycol chains) that forms porous, highly biocompatible hydrogels with a thread-like architecture that resembles the structures and mechanical properties of biogels based on collagen and fibrin.

The researchers combined this type of hydrogel with a photosensitizer based on a polythiophene. In solution it forms disordered clumps and absorbs violet light. Incorporation into the spiral-shaped regions of the hydrogel forces the polythiophenes into a straight, linear configuration. In this form, the absorption is significantly stronger and shifted into the red region of the spectrum. This is preferable because red light can penetrate deeper and causes less bleaching of the pigment.


The researchers thus obtained a gel with outstanding antimicrobial power against bacteria, such as Escherichia coli and Bacillus subtilis, as well as fungi like Candida albicans. This could be a starting point for making wound dressings with "built-in infection stoppers." The advantages of this method of fighting pathogens: it is non-invasive and its effect is controllable both in location and duration. Even antibiotic-resistant bacteria can be killed and the risk of causing new resistances is much lower.

See:

Hongbo Yuan, Yong Zhan, Alan E. Rowan, Chengfen Xing, Paul H. J. Kouwer. Biomimetic Networks with Enhanced Photodynamic Antimicrobial Activity from Conjugated Polythiophene/Polyisocyanide Hybrid Hydrogels. Angewandte Chemie International Edition, 2020; DOI: 10.1002/anie.201910979

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

Sunday, 16 February 2020

International collaboration on GMP inspections – manufacturers of sterile medicines.


In December 2019, EMA and its European and international partners launched a pilot programme to share information on GMP inspections of manufacturers of sterile medicines located outside the participating countries and to organise joint inspections of manufacturing sites of common interest. The products in scope include sterile medicines for human use of chemical origin and certain therapeutic biotechnology -derived products, such as monoclonal antibodies and recombinant proteins. Vaccines, cell and gene therapies and plasma derived pharmaceuticals are currently out of the scope of this pilot. For the terms of reference, objectives and full scope.


This initiative builds on the success and experience with the API inspection programme.

See: https://www.ema.europa.eu/en/human-regulatory/research-development/compliance/good-manufacturing-practice/international-collaboration-gmp-inspections

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

Saturday, 15 February 2020

1 in Every 5 Deaths Worldwide Associated With Sepsis, the Lancet Study Reveals


The Lancet published a groundbreaking study on sepsis yesterday – the results are concerning:
  • Twice as many people are dying from sepsis worldwide than previously estimated, with 48.9 million cases and 11 million deaths in 2017 alone
  • 1 in every 5 deaths worldwide are associated with sepsis
  • 2 out of every 5 cases are in children under 5
  • 85 % occur in low- or middle-income countries, and much more...
The full study, including a comment and press releases, are available on the World Sepsis Day website.

Although the number of cases are much higher than previously estimated, it is important to note that great international and collaborative work has been done worldwide in the past decades to fight sepsis. These efforts are conveyed in the study which examined annual sepsis incidence and mortality trends from 1990 to 2017. The study found that rates are actually decreasing.

Sepsis is a potentially life-threatening condition caused by the body's response to an infection. The body normally releases chemicals into the bloodstream to fight an infection. Sepsis occurs when the body's response to these chemicals is out of balance, triggering changes that can damage multiple organ systems.

In 1990, there were an estimated 60.2 million sepsis cases and 15.7 million deaths, compared to the 48.9 million cases and 11 million deaths in 2017. However, the study highlights we still have a long way to go in the global fight against sepsis and we need to continue to build upon the work being done worldwide.

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

Friday, 14 February 2020

Scientists develop electrochemical platform for cell-free synthetic biology



Scientists at the University of Toronto (U of T) and Arizona State University (ASU) have developed the first direct gene circuit to electrode interface by combining cell-free synthetic biology with state-of-the-art nanostructured electrodes.

Long inspired by concepts from the field of electronics, with its circuits and logic gates, synthetic biologists have sought to reprogram biological systems to carry out artificial functions for medical, environmental, and pharmaceutical applications. This new work moves the field of synthetic biology toward biohybrid systems that can take advantage of benefits from each discipline.

Bringing the capacity to detect the Zika virus outside of the clinic and to the point-of-need was a crucial step forward, but the approach relied on conventional optical signaling -- a change in colour to indicate that the virus had been detected. This posed a challenge for practical implementation in countries like Brazil where viruses with similar symptoms require health care providers to screen for several different pathogens in order to correctly identify the cause of a patient's infection.

This highlighted the need for a portable system that could accommodate many sensors in the same diagnostic test, a capability known as multiplexing. The challenge was that multiplexing with colour-based signaling is not practical.


The new biohybrid system uses non-optical reporter enzymes contained within 16 microlitres of liquid which pair specifically with micropatterned electrodes hosted on a small chip no more than one inch in length. Within this chip, gene-circuit-based sensors monitor the presence of specific nucleic acid sequences, which, when activated, trigger the production of one of a panel of the reporter enzymes. The enzymes then react with reporter DNA sequences that set off an electrochemical response on the electrode sensor chip.

See:

Peivand Sadat Mousavi, Sarah J. Smith, Jenise B. Chen, Margot Karlikow, Aidan Tinafar, Clare Robinson, Wenhan Liu, Duo Ma, Alexander A. Green, Shana O. Kelley, Keith Pardee. A multiplexed, electrochemical interface for gene-circuit-based sensors. Nature Chemistry, 2019; DOI: 10.1038/s41557-019-0366-y

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

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