Saturday, 30 September 2017

Fungi are key players of the deep biosphere



In addition to the life on the surface of Earth and in its oceans, ecosystems have evolved deep under us in a realm coined the "deep biosphere" which stretches several kilometers down into the bedrock. Down there, the conditions are harsh and life is forced to adjust to a lifestyle that we at the surface would call extreme. One major difference to surface conditions is the lack of oxygen; a compound we take for granted and consider to be a prerequisite for survival but which subsurface life has to cope without.

The knowledge about ancient life in this deep environment is extremely scarce and most studies so far have focused on the prokaryotes. A new study by an international team of researchers led by Dr Henrik Drake of the Linnaeus University and Dr Magnus Ivarsson of the Swedish Museum of Natural History sheds light on eukaryotes in this deep setting. They present the first in situ finding of fungi at great depth in the bedrock. This ancient life is found at 740 m below the ground surface. It represents a new piece in the deep biosphere puzzle.

High spatial resolution isotope analysis within the minerals that occur along with the fungi revealed that a variety of microbial processes had occurred in the caveat, including methane consumption and sulfate reduction. The fungi could not be dated precisely but there are proxies pointing to an age of tens of millions of years.

The study confirms a previously hypothesized consortium between fungi and sulfate reducing bacteria, a coupling that has yet been unsupported by direct evidence in nature. As fungi provide hydrogen gas that fuel prokaryotes, the findings suggest a re-evaluation of the energy cycling within the energy-poor deep continental biosphere. Eukaryotes have been neglected in the deep biosphere research. This new finding proposes that they may be key players in this globally vast realm.

Studies of subterranean life-forms have implications for early life on our planet and for life on other planets, where hostile conditions may have inhibited colonization of the surface.

See:

Henrik Drake, Magnus Ivarsson, Stefan Bengtson, Christine Heim, Sandra Siljeström, Martin J. Whitehouse, Curt Broman, Veneta Belivanova, Mats E. Åström. Anaerobic consortia of fungi and sulfate reducing bacteria in deep granite fracturesNature Communications, 2017; 8 (1) DOI: 10.1038/s41467-017-00094-6

 Posted by Dr. Tim Sandle

Friday, 29 September 2017

Study contradicts widely held belief on length of antibiotics use


A new study emerged, published in the BMJ has countered this by suggesting that this direction is not based on evidence.

The study actively argues against the “complete the course” mantra, suggesting that patients should instead stop taking the medication when they feel back to full health. The researchers suggest that the long-held belief to fully complete a course of antibiotics has been held under the presumption that this was the safest route to ensure that mutations in bacteria did not occur.

Now, they postulate that this may be the exact opposite of what would happen – with longer courses ensuring that bacteria are unnecessarily exposed to antibiotics, increasing the opportunity for them to mutate.

The researchers recommend that shorter courses should be delivered to patients and that the length of the regimen should be determined by the evidence, either on existing data or by undertaking clinical trials to better evaluate this.

At the heart of the debate is the growing threat of antibiotic resistance, as more evidence emerges from around the world of the growing inefficacy of many forms of antibiotics, including so called ‘last-resort’ antibiotics.

Professor Helen Stokes-Lampard, Chair of the RCGP, responded to the study: “We are concerned about the concept of patients stopping taking their medication mid-way through a course once they ‘feel better’, because improvement in symptoms does not necessarily mean the infection has been completely eradicated. It’s important that patients have clear messages and the mantra to always take the full course of antibiotics is well known – changing this will simply confuse people.”

For further details see: Pharma File

Posted by Dr. Tim Sandle

Thursday, 28 September 2017

Bacteria busting detergent


Advertorial:

There seems to be no shortage of ways to stay fresh and clean these days—in recent news, everything from MIT biofabrics that leverage living bacteria, to T-shirts made from coffee beans, are claiming to answer the ever-growing problem for workout warriors everywhere- Why Do My Gym Clothes Still Stink Even After I Wash Them?

But what if there was a simple solution that didn’t involve buying expensive, high tech clothing, and was as easy as getting back to basics? We’re referring of course, to your choice of detergent.

HEX Advanced Performance Detergent, founded by a professional lacrosse player Drew Westervelt, targets a big challenge for traditional household legacy detergent brands- today, over 60% of clothing contains synthetic fibers (including and especially athleisure). Mainstream detergents simply weren’t designed to properly clean synthetic fibers- they were created at a time when most clothes were made from cotton.

The result: bacteria from your sweat never fully goes away, even after washing. So it continues to pick up odor over time, and before you know it your $100 pair of Lululemon leggings is ruined!
Case in point: in a test conducted by the International Antimicrobial Council, Lululemon yoga pants were sent to be laundered with 187,000 bacteria on them. After five washes with traditional detergent, they came out of the dryer with a whopping 747,000 bacteria!

And the problem doesn’t just apply to gym clothes. Anything that isn’t cotton is at risk for not being properly washed by traditional brands, meaning you’re literally wasting hundreds of dollars a year (and possibly thousands when you factor in the cost of your clothes) by choosing the wrong detergent.

Hex Performance is sold in over 4,000 stores nationwide, at major retailers like Target, and is available on Amazon.

Wednesday, 27 September 2017

Yeast helps hunt for new medicines


Scientists have developed a new way to predict potentially useful drugs from a pool of undefined chemicals. They were able to more quickly identify leads that could be used to treat a range of diseases, from infections, to cancer to Alzheimer's. The finding will also help better match drugs to a disease to maximize the benefit and reduce side-effects.

The study, published in the journal Nature Chemical Biology, tested how nearly 14,000 compounds, hundreds of which were previously unexplored, affect basic cellular processes, to alert drug makers towards chemicals that are most likely to target a particular disease. The data pointed to ~1000 chemicals, many of which are natural products derived from soil microbes, as a rich source of potential medicines against a many diseases, including infections, Alzheimer's and cancer.

Despite modern technology, drug discovery still largely rests on guesswork. To find a drug that, say, kills cancer cells, scientists sift through libraries containing thousands of chemical compounds, the majority of which will have no effect at all.

Yeasts are currently the only living organism in which scientists have a good handle on the basic cellular processes, such as DNA replication and repair, energy production, and transport of cargo molecules, allowing them to link a drug to a particular bioprocess. Because natural compounds were shaped by evolution to act on living organisms, they are better candidates for future medicines than synthetic compounds that often do not even get into the cells.

For further details see:

Jeff S Piotrowski, Sheena C Li, Raamesh Deshpande, Scott W Simpkins, Justin Nelson, Yoko Yashiroda, Jacqueline M Barber, Hamid Safizadeh, Erin Wilson, Hiroki Okada, Abraham A Gebre, Karen Kubo, Nikko P Torres, Marissa A LeBlanc, Kerry Andrusiak, Reika Okamoto, Mami Yoshimura, Eva DeRango-Adem, Jolanda van Leeuwen, Katsuhiko Shirahige, Anastasia Baryshnikova, Grant W Brown, Hiroyuki Hirano, Michael Costanzo, Brenda Andrews, Yoshikazu Ohya, Hiroyuki Osada, Minoru Yoshida, Chad L Myers, Charles Boone. Functional annotation of chemical libraries across diverse biological processesNature Chemical Biology, 2017; DOI: 10.1038/nchembio.2436

Posted by Dr. Tim Sandle

Tuesday, 26 September 2017

Written procedures for new applicants for Wholesale Dealer Authorisations


The MHRA blog contains an article of interest for those involved with regulatory activities. The blog is titled “Creating written procedures for new applicants for Wholesale Dealer Authorisations (WDA)”, and it is written by Steve Todd.

The blog is aimed at new applicants who are establishing a small wholesale dealers’ operation. This subject is referred to as Quality Management in the EU GDP Guidelines 2013 and is covered in Chapter 1.

The blog can be accessed here.



Posted by Dr. Tim Sandle

Monday, 25 September 2017

Community acquired pneumonia in children


Pneumonia in children of all age groups has a strong association with morbidity. This highlights the importance of studying the clinical and diagnostic aspects of community-acquired pneumonia. For those suffering from pneumonia, general biological patterns, in some cases, outstrip morphological changes in tissues and therefore biological changes can be considered as early signs of the development of the disease. Through this research, we looked at the possibility of using proinflammatory cytokines in the urine, by a non-invasive method, to assess the prognosis of community-acquired pneumonia in children.

A new publication of interest:

“To study the possibility of using IL-6 content in biological fluids in order to predict the severity of community-acquired pneumonia in children.”

The reference is:

Akhayeva, A., Azizov, I., Kenzhetayeva, T., Zhupenova, D., Sandle, T., Gyurka, A. G., Pestrea, S.A. and Chesca, A. (2017) Diagnostic value of IL-6 for community acquired pneumonia in children, Archives of the Balkan Medical Union, 52 (2): 11-14

For further details, contact Tim Sandle

Posted by Dr. Tim Sandle

Sunday, 24 September 2017

How bacteria maintain and recover their shape


Bacteria have an extraordinary ability to maintain and recover their morphology even after being twisted out of shape. Shape plays an important role in how bacteria infiltrate and attack cells in the body. The helical shape of Helicobacter pylori, a species of bacteria which can cause ulcers, may help it penetrate tissues.

Researchers know that shape is determined by the cell wall, yet little is known about how bacteria monitor and control it. Since the cell wall is the target of most antibiotics, understanding how bacteria grow their cell walls may provide insight into more effective medicines. Now, a team of researchers has found that Escherichia coli may use mechanical cues to keep their shape.

In the new research, Harvard John A. Paulson School of Engineering and Applied Sciences researchers explored whether coupling wall growth to mechanical strain -- how the bacterium was compressed or stretched -- could explain the snapback and predict how fast the bacteria would straighten when released.

See:

Felix Wong, Lars D. Renner, Gizem Özbaykal, Jayson Paulose, Douglas B. Weibel, Sven van Teeffelen, Ariel Amir. Mechanical strain sensing implicated in cell shape recovery in Escherichia coliNature Microbiology, 2017; 2: 17115 DOI: 10.1038/nmicrobiol.2017.115
Posted by Dr. Tim Sandle

Saturday, 23 September 2017

How S. aureus spreads resistance to antibiotics



Infection by S. aureus is a serious threat in hospitals worldwide. Now, scientists have identified a key component of the machinery that allows Staphylococcus aureus to transfer genes that confer antibiotic resistance. Halting the spread of resistant bacterial strains is one of the strategies available to tackle hospital infections.

Antibiotic resistance of the bacterium Staphylococcus aureus is responsible for 11,300 deaths a year in the United States alone -- a figure that corresponds to half of all deaths caused by gram-positive resistant bacteria in that country. Such high mortality is related to the speed at which the bacterium acquires resistance to antibiotics. A study performed at the Institute for Research in Biomedicine (IRB Barcelona) and involving the collaboration of the Centro de Investigaciones Biológicas (CIB-CSIC) in Madrid has identified the key component of the machinery that S. aureus uses to acquire and transfer genes that confer resistance to antibiotics.

Horizontal gene transfer involves machinery in which the relaxase, an enzymatic protein, is a key component. Thanks to the 3D resolution of the structure of the complex formed by the relaxase with a fragment of the plasmid DNA, the researchers have identified that an amino acid histidine is a pivotal element in the DNA processing and thus in the transfer and the spread of resistance.

"What we have discovered is that the relaxase of diverse strains of S. aureus differs because it uses an amino acid that is not used by any other relaxase that we know of," explains the first author of the study, Radoslaw Pluta, former "la Caixa" PhD student at IRB Barcelona, and currently a postdoctoral researcher at the International Institute of Molecular and Cell Biology in Warsaw, Poland.

Histidine is the catalytic residue that allows the relaxase to cut DNA, bind to it, and stretch one of the two strands and take it into the receptor bacterium, where the strand replicates to form a double strand of the plasmid again. This new plasmid now holds the resistance genes and the machinery to transfer them to another bacterium. The scientists indicate that this catalytic histidine is present in the relaxases of 85% of the strains of Staphylococcus aureus.

To test whether histidine is decisive in horizontal gene transfer,, researchers in Manuel Espinosa's group at the CIB-CSIC, who participated in the study, replaced it by a different amino acid and confirmed that it prevents transfer in culture dishes.

The mutation of histidine does not kill that bacterium but rather prevents gene transfer. How could this mechanism be exploited to fight infections? This requires further study.

See:

Radoslaw Pluta, D. Roeland Boer, Fabián Lorenzo-Díaz, Silvia Russi, Hansel Gómez, Cris Fernández-López, Rosa Pérez-Luque, Modesto Orozco, Manuel Espinosa and Miquel Coll. Structural basis of a novel histidine-DNA nicking/joining mechanism for gene transfer and promiscuous spread of antibiotic resistanceProceedings of the National Academic of Sciences, July 2017 DOI: 10.1073/pnas.1702971114

Posted by Dr. Tim Sandle

Friday, 22 September 2017

Key Factors for Producing Error Free Pharma Packaging


The pharmaceutical industry stands for one of the fastest growing and the most profitable industries in the world. An increase in sales and growth of the work amount, apart from the high profit, can bring some unwanted problems and challenges for the pharmaceutical manufacturers when it comes to packaging.

This is a guest post by John Alex.
Although in the last several years we have witnessed a great revolution of automation tools for packaging quality control, a great number of manufacturers are still not up to the task with the technological advancements which can help with packaging issues.

Specifics of the pharmaceutical industry

The pharmaceutical industry represents one of the most demanding industries in the world and as such has a developed set of packaging quality control rules and regulations under the authority of FDA.

The specific regulations relate to a whole range of necessary activities in the production, research, creation of the products, product protection, and market placement.

Because of the global nature of the pharmaceutical industry, companies have to deal with different regulations worldwide which have the consequence that companies need to be adept in interpreting the different requirements of local regulations.

Such a variety of numerous and special legal regulations are the culprit factor of production and packaging mistakes.

Pharmaceutical manufacturers on the global market are often under pressure to deliver safer superior packaging, more effective medications affordable in less time and at a lower cost.

“Markets and Markets” are estimating that the global pharmaceutical market will grow at a CAGR of 6.7% from 2013 to 2018, reaching a value of $78,8 billion.

This value includes medications delivery systems that are also considered to be product packaging. This sector of the packaging market is growing at an even faster CAGR of 9.1% due to increasing demand for delivery/packaging solutions as many medications come off-patent in the coming years. (1) The Rx medicine packaging and OTC medicine packaging

There are two types of products in the pharmaceutical industry that significantly determine a packaging process approach.

First are the medicines that are only given through physician prescription, so-called Rx medicines. The second are medicines that can be purchased in retail, so-called over the counter ie. OTC medication.

For a long time, Rx medicines products were not given much artwork packaging importance because these medicines are intended for a very narrow circle of professionals- pharmacist and doctors. Because of that, the packaging artwork of Rx products has been focused solely on the basic elements necessary for correct use of medical products.

This lack of packaging attractiveness, of course, does not exclude the importance of up-to-date and accurate information on the medication package. This includes information about ingredients, dosage, and mode of application.

A medication package should not be similar to any other form of packaging in order to avoid confusion with other types of products.

There is a general rule that non-pharmaceutical products should not be packed in packaging which resembles a blister pack (e.g. chewing gum) so that children do not get used to opening such packaging, which could endanger their safety.

The appearance of OTC medications is nowadays approached as a form of promotion by which the pharmaceutical industry has finally reached a mass media access point in advertising, thus more direct access to consumers without the intermediary of doctors.

The packaging of these products allows much greater freedom for creativity in creating attractive product packaging. But, this also leaves plenty of room for errors usually caused by human factor. That often leads to complete products recalls, which represents the worst-case scenario for the manufacturers.

According to Esko's market research, it is estimated that more than 50% of product recalls are related to the labeling or packaging artwork, and more than 60% of recalls are caused by human error. (2)

Factors determining the attractiveness of packaging include imaginative and innovative packaging artwork.

Since quality should not suffer due to packaging design, it is equally important to ensure that the product keeps its credibility as well as providing the sense of responsibility and security, to inform the consumer of the benefits of using the product and to provide the information on proper use and warnings in case of improper use.

Besides protecting the product from external influences, the packaging must make it easier to consume products, protect products, and prevent abuse while ensuring the entire process of delivering the product to the end user.

Smart and intelligent packaging labels as a response to the demanding modern market

Lately, there is an increasing demand for smart and intelligent packaging labels, with the goal of maximum product protection and achieving clearer communication with the consumers.

As smart packaging labels, we consider the packaging labels which contain the crucial data, information, and solutions regarding the product process, distribution, and sales.

A newer technology advancement is the use of packaging labels that observe temperature oscillations, possible growth of microorganisms, labels that have moisture-absorbing properties, indicators that show products freshness, light protection etc.

The greatest thing about smart packaging labels is the fact they can serve as a means for feedback from the product consumers themselves which manufacturers can find very [1] [2] useful.

Packaging against counterfeiting

The pharmaceutical industry permanently continues to face challenges with an increased number of counterfeit medicines and medical products.

One of the reasons for this is certainly high medication prices but also an opportunity for the black market to take up the part of pharmaceutical “market cake”. The challenge of protecting pharmaceuticals from counterfeiting continues to be one of the greatest issues in less developed countries.

The pharmaceutical industry is very sensitive to any kind of counterfeiting and misuse of the product. This is because every counterfeiting means a direct threat to the health and life of consumers. The riskiest group being children and elderly.

Taking into account the fact that as many as 10% of the worldwide medicines are falsified, it is easy to conclude why the pharmaceutical industry invests so much effort and money into the contemporary forms of protecting its products.

One of the possible ways to combat medicines counterfeit is packaging with protective elements. Among these elements is Braille text. Most legitimate pharmaceutical manufacturers take care of special user categories, so most of the pharmaceutical packaging also contains Braille.
Implementation of Braille to the medication product packaging is a sensitive and technically demanding process. Important information has to translate to Braille clearly and accurately.

Braille text itself, is not a great protection. But, its presence on the packaging in combination with other protection elements makes it much more difficult to counterfeit the original medication's packaging.

Another way of counterfeit protection is the amendment to the Falsified Medicines Directive (FMD), among which are serialization and the tamper seal.

Manual VS Automation packaging process

The use of automation technology for both, primary and secondary pharmaceutical packaging can help manufacturers save time, minimise errors, reduce costs and ensure an aseptic manufacturing process.

Primary packaging includes aseptic fill-finish and capping equipment, non-aseptic fill-finishing and capping equipment, unit dose fill-seal, blow/fill/seal, inspection systems, containment solutions, and product assembly lines.

Secondary packaging includes cartooning equipment, overwrappers and stretches banners, bulk packaging equipment, check weighers, serialization equipment, tamper-evident solutions and end packaging. (3)

It is evident that such a complex manufacturing process requires strict and efficient control in order to protect consumers themselves as well as manufacturers.

Since packaging of pharmaceuticals often contains small and complex details, much of the product information is often printed in small dots, barcodes, and graphics.

Because of its technical nature, manual inspection of these products is highly inadvisable, so packaging printing inspection automation technology should be introduced into the production process.

A good packaging quality control software platform should adhere to the rules and regulations of the pharmaceutical quality control standards.

Beside the individual packaging quality control segments which can be automated - Braille text, spelling, artwork label, text inspection, data integrity, pixel proof, graphics inspection, packaging print, discount, quality control inspection, preprint and print; it is possible to integrate an all in one quality control platform into the workflow and producing process.(4)

A packaging quality control platform which offers an all in one solution and is also integrable with other systems and hardware encompasses most pharmaceutical packaging challenges and provides the best value of ROI which is also an important business segment and goal of every manufacturer.

References:

1.(Markets and Markets. Pharmaceutical packaging market by packaging type (plastic bottles, blister packs, caps & closures, ampoules, vials and others) raw material (plastics, paper & paperboard, glass, aluminum foils), and drug delivery type–global trends & forecast to 2018.

http://www.marketsandmarkets.com/Market-Reports/pharmaceutical-packaging-market-890.html.

2. Philippe Adam, Global Marketing, Esko Best Practices:- How to Avoid the Five Common Pharma Packaging and Labelling Artwork Hurdles

http://www.pharmtech.com/best-practices-how-avoid-five-common-pharma-packaging-and-labelling-artwork-hurdles

3. KshitiJ (TJ) Ladage, Market Research Manager, Nice Insight, Nice Insight Pharmaceutical Equipment 2016 Annual Study

https://www.pharmasalmanac.com/articles/q2-ni-nice-insight-pharmaceutical-equipment-2016-annual-study

4. Mike Spooner, Integrating Quality Control Tools Into Print Workflow Automation Solutions

http://www.globalvisioninc.com/blog/saas/integrating-qc-tools-into-print-workflow-automation-solutions/

Author Bio: John Alex is a freelance writer, experienced blogger, and a professional social media coach. Currently, He’s working with globalvisioninc.com. Furthermore, John assists in the business creation and control social media content planning.

Thursday, 21 September 2017

Analysis Of FDA Warning Letters

Failures in data governance and data integrity have been more prominent in health authority enforcement actions in the past few years. This is the focus of a review of FDA warning letters and data integrity concerns, conducted by Barbara Unger, Unger Consulting Inc., for Pharmaceutical Online.

Here is an extract:

Failures in data governance and data integrity continue to be addressed in approximately 80 percent of FDA warning letters issued to both domestic and foreign sites. Requirements in this area apply to both paper records and electronic records. Warning letters continue to cite similar deficiencies to those identified between 1999 and 2006, including computer systems not validated for their intended purpose, lack of controls over computerized systems to prevent access by unauthorized users, and failure to evaluate all original data (including audit trails) generated in testing and to consider the results as part of the lot release decisions.

To access the article, see Pharmaceutical Online.



Posted by Dr. Tim Sandle

Wednesday, 20 September 2017

Cases of superbug Clostridium difficile increase


The most troubling cases of C. difficile infection, termed multiple recurring C. difficile infections (mrCDI), are becoming more common, according to a new university research study.

The study comes from the University of Pennsylvania School of Medicine and it highlights a concern within the U.S. healthcare network (made up of 40 million patient records). The data was drawn from a large, nationwide health insurance database. The big data analysis not only informs about the general Clostridium difficile rate (which affects over half a million U.S. citizens each year), it shows the extent of recurrent infections.

Clostridium difficile infection refers to a symptomatic infection due to the spore-forming bacterium. By being spore forming the organism is hard to kill. Symptoms of infection can include watery diarrhea, fever, nausea, and abdominal pain. Further complications can include pseudomembranous colitis, toxic megacolon, perforation of the colon, and sepsis.

Multiple recurring C. difficile infections raise concerns because recurrent infections increase the risk of death for already vulnerable patients. Reoccurrence also signals that attempts at eradication of this infection are failing. Furthermore recurrent cases also tend to involve more virulent strains of the bacterium. These risks have been described in an article for the journal Anaerobe headed “A case of multiple recurrence of Clostridium difficile infection with severe hematochezia in an immunocompromised host.”

The propensity of recurrence occurs in 15 to 35 percent of patients who initially respond to antimicrobial therapy. Due to the need to switch to different antibiotics, and the added complication of antibiotic resistance, the recurrent cases are especially difficult to treat and they contribute to significant morbidity and mortality and increased health care expenditures. Antibiotics called metronidazole, vancomycin, and fidoxamicin are often used to treat infections, but resistance can arise.

According to the new analysis, the reason for the sharp rise in mrCDI's incidence is uncertain; what is clear is that the cases are growing (rising by 43 percent over a recent ten year period). What the report does highlight is need for new approaches to treatment. An example of this is with fecal microbiota transplantation, where beneficial intestinal bacteria from one patient are infused into another to help out-compete the infective C. difficile. This needs more study, however, according to Professor James D. Lewis from the University of Pennsylvania: “While we know that fecal microbiota transplantation is generally safe and effective in the short term, we need to establish the long term safety of this procedure."



Posted by Dr. Tim Sandle

Tuesday, 19 September 2017

GLP Inspections metrics reflections


An MHRA blog post by Martin Reed looks at collation of the 2015 inspection metrics data.

According to Reed, these data have "highlighted some common themes which I am going to illustrate by sharing some examples with you. All of the situations below have been observed within the past 12 months and have resulted in deficiencies (some major) being raised. The aim of sharing these examples is for organisations to identify if these issues could occur at their own facilities and allow them to pro-actively improve compliance."

The report can be accessed here: MHRA



Posted by Dr. Tim Sandle

Monday, 18 September 2017

Design and control of pharmaceutical water systems


Water-borne microorganisms are ubiquitous and varied in their ability to survive and grow under different conditions. Therefore, an out-of-control water system can cause harm to the patient or adulterate pharmaceutical products. Purification of water is required to prevent interaction with drug substances or other ingredients in the product formulation. Water must also be microbiologically controlled and monitored.

In relation to this, Tim Sandle has written an article for Pharmaceutical Engineering. The abstract reads:

This article assesses some of the requirements for good design, together with the control measures necessary to maintain effective microbiological control in pharmaceutical facility water systems.

The reference is:

Sandle, T. (2017) Design and control of pharmaceutical water systems to minimize microbial contamination, Pharmaceutical Engineering, 37 (4): 44-48

For further details, contact Tim Sandle

Posted by Dr. Tim Sandle

Sunday, 17 September 2017

Magnetized viruses attack harmful bacteria



Antibacterial phages combined with magnetic nanoparticle clusters effectively kill infectious bacteria found in water treatment systems. A weak magnetic field draws the clusters into biofilms that protect the bacteria and break them up so the phages can reach them.

The nanoclusters developed through Rice's Nanotechnology-Enabled Water Treatment (NEWT) Engineering Research Center carry bacteriophages -- viruses that infect and propagate in bacteria -- and deliver them to targets that generally resist chemical disinfection. Without the pull of a magnetic host, these "phages" disperse in solution, largely fail to penetrate biofilms and allow bacteria to grow in solution and even corrode metal, a costly problem for water distribution systems.

The Rice lab of environmental engineer Pedro Alvarez and colleagues in China developed and tested clusters that immobilize the phages. A weak magnetic field draws them into biofilms to their targets. Biofilms can be beneficial in some wastewater treatment or industrial fermentation reactors owing to their enhanced reaction rates and resistance to exogenous stresses, said Rice graduate student and co-lead author Pingfeng Yu. "However, biofilms can be very harmful in water distribution and storage systems since they can shelter pathogenic microorganisms that pose significant public health concerns and may also contribute to corrosion and associated economic losses," he said.

The lab used phages that are polyvalent -- able to attack more than one type of bacteria -- to target lab-grown films that contained strains of Escherichia coli associated with infectious diseases and Pseudomonas aeruginosa, which is prone to antibiotic resistance.

The phages were combined with nanoclusters of carbon, sulfur and iron oxide that were further modified with amino groups. The amino coating prompted the phages to bond with the clusters head-first, which left their infectious tails exposed and able to infect bacteria.

The researchers used a relatively weak magnetic field to push the nanoclusters into the film and disrupt it. Images showed they effectively killed E. coli and P. aeruginosa over around 90 percent of the film in a test 96-well plate versus less than 40 percent in a plate with phages alone.

The researchers noted bacteria may still develop resistance to phages, but the ability to quickly disrupt biofilms would make that more difficult. Alvarez said the lab is working on phage "cocktails" that would combine multiple types of phages and/or antibiotics with the particles to inhibit resistance.

See:

Ling-Li Li, Pingfeng Yu, Xifan Wang, Sheng-Song Yu, Jacques Mathieu, Han-Qing Yu, Pedro J. J. Alvarez. Enhanced biofilm penetration for microbial control by polyvalent phages conjugated with magnetic colloidal nanoparticle clusters (CNCs)Environ. Sci.: Nano, 2017; DOI: 10.1039/C7EN00414A

Posted by Dr. Tim Sandle

Saturday, 16 September 2017

Plan for the introduction of the safety features on medicinal packaging


The European Medicines Agency (EMA) has issued a new guidance document titled “Implementation plan for the introduction of the safety features on the packaging of centrally authorized medicinal products for human use.”

Certain aspects of the implementation of the Falsified Medicines Directive (Directive 2011/62/EU) and the new delegated act on the safety features (Commission Delegated Regulation (EU) 2016/161 - "the Delegated Regulation") may impact on the product information and the marketing authorization dossier; in particular the placing of safety features, a unique identifier (UI) carried by a 2-D barcode and an anti-tampering device (ATD), on the packaging of prescription medicines and certain nonprescription medicines for the purposes of authentication and identification.

The European Medicines Agency and the European Commission have prepared this implementation plan to guide applicants and Marketing Authorisation Holders (MAHs) through the regulatory changes necessary to accommodate the new legislative requirements.

The document can be accessed here.



Posted by Dr. Tim Sandle