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EMA and the European Directorate for the Quality of Medicines & Healthcare (EDQM) have reviewed EMA’s sampling and testing programme for centrally authorised medicines on the EU/EEA market, which has been organised yearly since 1998.

The number of centrally authorised medicines tested every year has steadily increased from nine in the 1997-1998 pilot project to 58 in 2017, totalling over 700 products. Most of the issues identified during the testing resulted in EMA requiring companies to amend the registered manufacturer’s control methods for their medicines. In a small number of cases, the tested samples were not compliant with the authorised quality specifications for the medicine and required other regulatory actions such as re-testing, inspections, recalls or suspension of supply. These are some of the key findings in a report summarising the sampling and testing activities and main achievements over the past 20 years.


The programme is an important part of the supervision of the quality of centrally authorised products (CAPs) for human and veterinary use in all parts of the distribution chain. The tests are aimed at verifying the compliance of medicines with their authorised specifications and ensuring that the manufacturer’s control methods are satisfactory.

To access the report, see: https://www.ema.europa.eu/documents/report/20-years-sampling-testing-centrally-authorised-products-1998-2017_en.pdf

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology
Pharmaceutical Microbiology (c) Dr Tim Sandle http://www.pharmamicroresources.com
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Scientists report on a new method that takes advantage of engineered bacteria to produce spider silk and other difficult-to-make proteins that could be useful during future space missions.

If produced in sufficient quantities, spider silk could be used for a variety of applications, ranging from bullet-proof fabric to surgical sutures. But spider silk isn't easy to farm -- spiders produce tiny quantities, and some species turn cannibalistic when kept in groups. Therefore, scientists have tried engineering bacteria, yeast, plants and even goats to produce spider silk, but they haven't yet been able to fully replicate the natural fiber's mechanical properties.

Part of the problem is that spider silk proteins are encoded by very long, highly repetitive sequences of DNA. Spiders have evolved ways to keep these sequences in their genome. But when scientists put this type of DNA into other organisms, the genes are very unstable, often getting snipped or otherwise altered by the host's cellular machinery. Zhang and colleagues at Washington University in St. Louis wondered if they could break the long, repetitive sequences into shorter blocks that bacteria could handle and make into proteins. Then, the researchers could assemble the shorter proteins into the longer spider silk fiber.

READ MORE: ISS is not causing bacteria to mutate into dangerous, antibiotic-resistant superbugs

The team introduced genes to bacteria that encoded two pieces of the spider silk protein, each flanked by a sequence called a split intein. Split inteins are naturally occurring protein sequences with enzymatic activity: Two split inteins on different protein fragments can join and then cut themselves out to yield an intact protein. After introducing the genes, the researchers broke open the bacteria and purified the short pieces of spider silk protein. Mixing the fragments caused them to join together through the "glue" of the split intein sequence, which then cut itself out to yield the full-length protein. When spun into fibers, the microbially produced spider silk had all of the properties of natural spider silk, including exceptional strength, toughness and stretchability. The researchers obtained more silk with this method than they could from spiders (as much as two grams of silk per liter of bacterial culture), and they are currently trying to increase the yield even more.

The researchers can make various repetitive proteins simply by swapping out the spider silk DNA and putting other sequences into bacteria. For example, the researchers used the technique to make a protein from mussels that adheres strongly to surfaces. The protein could someday be applied as an underwater adhesive. Now, the researchers are working on streamlining the process so that the protein-joining reaction can occur inside bacterial cells. This would improve the efficiency and potential automation of the system because researchers wouldn't have to purify the two pieces of the protein and then incubate them together.

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology
Pharmaceutical Microbiology (c) Dr Tim Sandle http://www.pharmamicroresources.com
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A highly drug-resistant bacteria common in hospitals, Klebsiella pneumoniae, represents a significant antimicrobial resistance threat and should be monitored globally, say researchers. The warning follows new genetic analyses revealing how K. pneumoniae are able to quickly evolve to change their genetic makeup. This has implications for understanding how several species of bacteria -- called Enterobacteriaceae -- can rapidly adapt to essentially any antibiotic currently used in treatment.

By genetically analysing 100 strains of K. pneumoniae bacteria sampled from infected patients, carriers without symptoms and the hospital ward environment over a 14-month period, they found that the bacteria were highly transmissible and able to genetically adapt to any available antibiotic within very short periods of time.


The hospital outbreak strains of K. pneumoniae were found to be very highly drug-resistant, with all isolates analysed showing resistance to multiple drug classes, including to Carbapenems -- antibiotics used as a last resort in the treatment of severe infections.

With the number of deaths from drug-resistant infections predicted to rise from 700,000 to 10 million per year by 2050, Carbapenem-resistant Enterobacteriaceae are listed as one of three urgent threats by the Centers for Disease Control and Prevention and a key global 'critical-priority' by the World Health Organization.

READ MORE: Potential antibody treatment for multidrug-resistant K. pneumoniae

The team used whole genome DNA sequence data to reconstruct the evolution of the highly drug-resistant bacteria, including tracking their transmission within the hospital, spanning three campuses, 19 wards and two intensive care units. By using genome-wide genetic data the researchers could clearly follow their spread around the hospital. It's remarkable to see how easily these bacteria were moving between patients, particularly those in intensive care units, but we also found that they were transmitting across different hospital sites via ward equipment, including ward bed rails and medical devices.

The researchers found the bacteria were carrying many resistance plasmids, and in some cases these plasmids were present in multiple copies. We demonstrated that the number of copies helped to predict how successfully treatment was evaded by the bacteria. This means it isn't just the presence of a gene conferring resistance that is important, but also its abundance in an infecting strain.

Journal reference:

Lucy van Dorp, Qi Wang, Liam P. Shaw, Mislav Acman, Ola B. Brynildsrud, Vegard Eldholm, Ruobing Wang, Hua Gao, Yuyao Yin, Hongbin Chen, Chuling Ding, Rhys A. Farrer, Xavier Didelot, Francois Balloux, Hui Wang. Rapid phenotypic evolution in multidrug-resistant Klebsiella pneumoniae hospital outbreak strains. Microbial Genomics, 2019; DOI: 10.1099/mgen.0.000263
Posted by Dr. Tim Sandle, Pharmaceutical Microbiology
Pharmaceutical Microbiology (c) Dr Tim Sandle http://www.pharmamicroresources.com
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Patients with colorectal cancer have the same consistent changes in the gut bacteria across continents, cultures, and diets -- a team of international researchers find in a new study. The hope is the results in the future can be used to develop a new method of diagnosing colorectal cancer. This is based on research from the University of Copenhagen The Faculty of Health and Medical Sciences.

Cancers have long been known to arise due to environmental exposures such as unhealthy diet or smoking. Lately, the microbes living in and on our body have entered the stage as key players. But the role that gut microbes play in the development of colorectal cancer -- the third most common cancer worldwide -- is unclear. To determine their influence, association studies have aimed to map how the microbes colonizing the gut of colorectal cancer patients are different from those that inhabit healthy subjects.

Now, researchers have analysed multiple existing microbiome association studies of colorectal cancer together with newly generated data. Their meta-analyses establish disease-specific microbiome changes, which are globally robust -- consistent across seven countries on three continents -- despite differences in environment, diet and life style.


READ MORE: Killer immune cells that halt malaria could hold key to new vaccines

The study led by UCPH and EMBL scientists focuses on a process in which certain gut bacteria turn bile acids that are part of our digestive juices into metabolites that can be carcinogenic. A related study from the University of Trento shows how certain classes of bacteria degrade choline, an essential nutrient contained in meat and other foods, and turn it into a potentially dangerous metabolite. This metabolite has previously been shown to increase cardiovascular disease risk, and can now also be linked to colorectal cancer.

One of the challenges of metagenomic studies, which are based on genetic material from microbes in environmental samples such as stool, is to link genetic fragments to the various microbial organisms they belong to. The goal of this so-called taxonomic profiling task is to identify and quantify the bacterial species present in the sample.

The role of gut microbes in colorectal cancer still needs to be established. If the changes in the microbiome play a role in developing the cancer, they could also be a therapeutic target. Therefore, Manimozhiyan Arumugam hopes that there will be more focus on the role of microbiome in diseases and that researchers will recognize the advantages of collecting microbiome samples, for example, in large cohorts.

Journal reference:

Meta-analysis of fecal metagenomes reveals global microbial signatures that are specific for colorectal cancer. Nature Medicine, 2019; DOI: 10.1038/s41591-019-0406-6
Posted by Dr. Tim Sandle, Pharmaceutical Microbiology
Pharmaceutical Microbiology (c) Dr Tim Sandle http://www.pharmamicroresources.com
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New work is helping develop a better understanding of the growing threat posed by antifungal drug resistance. Invasive aspergillosis is a devastating disease caused by breathing in small airborne spores of the fungus Aspergillus fumigatus and it is a condition where drug resistance has been encountered. They have just released a paper revealing how they have been able to identify a previously uncharacterized genetic mutation in clinical isolates that leads to resistance.

Invasive aspergillosis is a devastating disease caused by breathing in small airborne spores of the fungus Aspergillus fumigatus and it is a condition where drug resistance has been encountered.

In a healthy person these spores are destroyed by the body's immune system but in those with a weakened immune system -- such as following organ transplantation or in someone with a lung condition such as asthma or cystic fibrosis -- they can trigger a range of problems including infections.

READ MORE: Fungal spore 'death clouds' key in gypsy moth fight

Every year aspergillosis leads to more than 200,000 life-threatening infections and increasingly resistance to vital antifungal drug treatments makes those infections harder to treat.

National Institutes of Health (USA) funding supported a collaboration between the University of Tennessee, the University of Texas and Swansea University as part of a $2 million, five-year research programme. This support enabled investigation of resistance to the triazole class of antifungal drugs used for treating the disease

A new paper shows how researchers have been able to identify a previously uncharacterised genetic mutation in clinical isolates that leads to resistance.

Journal reference:

Jeffrey M. Rybak, Wenbo Ge, Nathan P. Wiederhold, Josie E. Parker, Steven L. Kelly, P. David Rogers, Jarrod R. Fortwendel. Mutations in hmg1, Challenging the Paradigm of Clinical Triazole Resistance in Aspergillus fumigatus. mBio, 2019; 10 (2) DOI: 10.1128/mBio.00437-19
Posted by Dr. Tim Sandle, Pharmaceutical Microbiology
Pharmaceutical Microbiology (c) Dr Tim Sandle http://www.pharmamicroresources.com
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Testing for Endotoxins and Pyrogens?

Take a short survey (10 minutes) to help us understand your endotoxin and pyrogen testing needs.

For the first 100 respondents, a donation of 10 € per respondent will be given to the Seeding Labs charity organization.

To take the survey, please go to: https://millipore.az1.qualtrics.com/jfe/preview/SV_bkqFjZGNXaCUqvX 

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology
Pharmaceutical Microbiology (c) Dr Tim Sandle http://www.pharmamicroresources.com
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A probiotic has been found to help weaken stubborn microbial biofilm communities in the gut that can worsen symptoms. Researchers from Case Western Reserve University report.

Probiotics typically aim to rebalance bacteria populations in the gut, but new research suggests they may also help break apart stubborn biofilms. Biofilms are living microbial communities -- they provide a haven for microbes and are often resistant to antibiotics. A new study describes a specific probiotic mix that could help patients with gastrointestinal diseases avoid harmful biofilms that can worsen their symptoms.

The study evaluated the ability of a novel probiotic to prevent and treat biofilms containing yeast and bacteria -- in particular, species that thrive in damaged guts. Biofilms can contain an infectious polymicrobial mix of bacteria and fungi all living together underneath a thick protective slime. These polymicrobial communities are resistant to antibiotics, but can be antagonized by other microbes. Other microbes living in the gut -- or administered via probiotics -- can help break apart biofilms, according to the new study.

READ MORE: Probiotics Shown to Dramatically Improve IBS Gut Symptom

In a series of experiments researchers grew yeast (Candida species) and bacteria (Escherichia coli and Serratia marcescens) into biofilms. They then exposed the biofilms to a promising probiotic mix identified in a previous study -- one part yeast, three parts bacteria, and a small amount of amylase (an enzyme found in saliva). Microscope images showed biofilms exposed to the mix were looser-knit communities that were overall thinner and weaker than untreated biofilms.

The researchers found the probiotic worked in part by weakening yeast living in young biofilms. The yeast inside the biofilms were stunted in growth and did not form reproductive structures that help seed new biofilm growth and expansion. The researchers concluded their novel probiotic mix might help prevent harmful biofilms in people with inflammatory bowel disease or other gastrointestinal conditions.

Journal reference:

Christopher L. Hager, Nancy Isham, Kory P. Schrom, Jyotsna Chandra, Thomas McCormick, Masaru Miyagi, Mahmoud A. Ghannoum. Effects of a Novel Probiotic Combination on Pathogenic Bacterial-Fungal Polymicrobial Biofilms. mBio, 2019; DOI: 10.1128/mBio.00338-19
Posted by Dr. Tim Sandle, Pharmaceutical Microbiology
Pharmaceutical Microbiology (c) Dr Tim Sandle http://www.pharmamicroresources.com
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This new finding, from the Tokyo Institute of Technology, highlights the importance of microorganisms in the geochemistry of natural gas and petroleum.

Hydrocarbons play key roles in atmospheric and biogeochemistry, the energy economy, and climate change. Most hydrocarbons form in anaerobic environments through high temperature or microbial decomposition of organic matter. Subsurface microorganisms can also 'eat' hydrocarbons, preventing them from reaching the atmosphere. Using a new technique, scientists show that biological hydrocarbon degradation gives a unique biological signature. These findings could help detect subsurface biology and understand the carbon cycle and its impact on climate.

The researchers fed propane to microorganisms in the lab to measure the specific 12C/13C signature produced these organisms, and measured the non-biological changes that occurred when propane is broken down at high temperatures, a process known as "cracking." They then used these baseline measurements to interpret natural gas samples from the US, Canada and Australia, allowing them to detect the presence of microorganisms using propane as "food" in natural gas reservoirs, and to quantify the amount of hydrocarbons eaten by microorganisms.

READ MORE: Carbon monoxide improves effectiveness of antibiotic

When the researchers began analyzing samples from the bacterial simulation experiments, they matched perfectly what we observed in the field, suggesting the presence of propane degrading bacteria in the natural gas reservoirs.
Thus, this study revealed the presence of microorganisms that would have been difficult to detect using conventional methods, and opens a new window to understanding global hydrocarbon cycling.

Journal reference:

Intramolecular isotopic evidence for bacterial oxidation of propane in subsurface natural gas reservoirs. Proceedings of the National Academy of Sciences, 2019; 116 (14): 6653 DOI: 10.1073/pnas.1817784116

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology
Pharmaceutical Microbiology (c) Dr Tim Sandle http://www.pharmamicroresources.com
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The take-up of digital pathology technology is expected to increase during the next decade and the main adopters of this technology will be healthcare organizations, such as hospitals and diagnostic laboratories, according to a new report.

As well as digital technologies in general, the healthcare sector will be enhancing digital images with artificial intelligence to help pathologists to detect key signs earlier or to help with greater accuracy.

Other advantages that will arise from such technology are centered on decreasing turnaround time, prioritizing critical cases, and improving overall patient outcomes. To do so will involve innovating and developing tools for primary and secondary analysis.

These are key highlights from a new report issued by Frost & Sullivan. The report is titled “Digital Pathology: Roadmap to the Future of Medical Diagnosis.” The types of technologies within this space are digital whole slide scanning, digital imaging solutions, and offering a digital data repository, which can be subject to big data analysis.
Many of these technologies will enable researchers to access databases from the cloud and for hospitals to collaborate together, in terms of sharing images. It is also possible to send an image around the world so that a second opinion can be given from a specialist consultant.

The report charts how the regulatory landscape has shifted and there is proven method qualification to show that digital systems are very effective, resulting in the barriers to technology take-up and implementation being lower.

As an example, the digital pathology system, and artificial intelligence platform, OsteoDetect has gained approval from the U.S. Food and Drug Administration (FDA). The technology is used for the detection of distal radius fracture.

Commenting on the report, Deepak Jayakumar, Senior Research Analyst, TechVision states: “Artificial intelligence has the potential to analyze big data and find patterns and insights that could enhance patient outcomes in the field of pathology. It can serve as a supplementary or a validation tool in imaging analytics for pathologists, and help process more slides in a shorter duration."

He goes on to assess how these technologies will appeal strongest to hospitals and diagnostic laboratories. A driver for this will be seeking cost optimization for end users. This can be realized via pay-per-use or Software-as-a-Service (SaaS) models. A side effect of this will be to disrupt traditional models within the healthcare system.

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology
Pharmaceutical Microbiology (c) Dr Tim Sandle http://www.pharmamicroresources.com
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When a drone is used for the first time to deliver an organ to a transplant recipient, you know big things are afoot in the pharmaceutical cold chain.

So what else drives growth in this field? And which technologies are coming to the forefront to make this critical industry safer and more efficient? Let's take a look at some answers.

A guest post from Megan Ray Nichols

1. Personalized Medicines

One of the greatest disruptions to medicine in recent memory — and the cold chain that powers the pharma industry — is personalized medicine. Also called "precision medicine," this is the practice of specifically tailoring (and even 3D-printing) medications and gene and cell therapies for use by smaller, more specific sets of patients. According to a 2017 report by the Personalized Medicine Coalition, the next five years will see a 69% increase in the number of precision drugs coming to market.

This is a huge opportunity for cold chain and logistics companies — but it also presents some roadblocks. These are small-batch medications that must be delivered within very tight deadlines. Compared with larger shipments and uniform temperature control requirements, the challenges speak for themselves. Some of these bespoke medications, including monoclonal antibodies, are more fragile than others and more susceptible to environmental hazards. Supply chain and logistics companies must stand ready with more efficient business models and more advanced thermal packaging. 

2. Blockchain and Traceability Requirements

Visibility and transparency are even more important in cold chain logistics than in any other supply chain. Various countries and emerging markets have different track-and-trace requirements, but technology can help cut through the noise and provide a standardized approach to supply chain transparency.

Blockchain presents a way for pharmaceutical companies to comply with increasingly and appropriately stringent government regulations concerning the transportation of pharmaceutical products. For example, the FDA's Drug Supply Chain Security Act lays out expectations for "electronic, interoperable systems" for recording and reporting information on drug shipments, with the goal of rooting out counterfeit products and streamlining the auditing and reporting processes. But these electronic systems require accurate and timely data to be of any use.

With that in mind, it will likely become the norm for logistics companies to employ blockchain and attach a cryptographically unique identifier to pharmaceutical shipments. This blockchain "token" collects information from origin to destination and cannot be altered once recorded. As a result, logistics companies can visualize their entire supply chain in the name of safety and authenticity. 

3. Data Everywhere and the IoT

Adoption of the Internet of Things is ramping up across the medical landscape. According to a DHL report entitled "The Future of Life Sciences and Healthcare Logistics," the health care IoT market will grow to $646 million in value by 2020. Cold chain and logistics companies drive a great deal of this growth.

As the demand for traditional and personalized medicine alike grows, companies must be more vigilant than ever about optimizing their manufacturing processes, insulating themselves against disruptions and forecasting demand. The IoT and Big Data are key allies in these challenges:

As an example, Bayer plans out its antihistamine supply chain roughly nine months in advance using analytics that incorporate information about climate patterns, customer demand and historical and geographical trends for conditions like hay fever. This ensures their products get to where they're needed most and stores don't run out during peak demand.

IoT-enabled manufacturing equipment can collect data all the way from production through to distribution and provide insights that lead to process optimizations. If there's a department creating a bottleneck, an inefficient vendor, or a not-quite-optimally-placed distribution hub, companies can find out about it and make timelier decisions and operational changes.

Pharmaceutical products must be kept at stable temperatures during storage and transit, or risk spoilage. Remote monitoring using the IoT and cloud-based intelligence platforms can track critical metrics for every shipment and every variable-temperature, ambient and freezer storage space, and alert personnel if conditions drop below or rise above optimal levels. It's not just about the 32- to 37-degree model anymore — facilities must be more flexible and we need technologies to support that flexibility.

Predicting demand, ironing out the kinks in manufacturing and having "eyes on" every shipment at every moment brings greater efficiency and safety to the cold chain than was ever possible before the IoT came to the fore. 

4. Mergers, Partnerships and Acquisitions


If there's an overriding mission across just about every industry, it's to reduce the time it takes for a customer to receive their order after they click "buy." The "on-demand" and "same-day" business models have already changed entertainment and eCommerce for good — and they're about to do the same for health care.

In 2018, Amazon, J.P. Morgan and Berkshire Hathaway announced a partnership called "Haven" and declared their intention to disrupt the health care industry. Immediately afterward, CVS, Walmart, Express Scripts and Cardinal Health stocks all plummeted. They lost billions of dollars in value overnight.

This isn't Amazon's only move that looks ready to shake up the cold chain industry. The retail giant also owns Whole Foods and more recently acquired PillPack — an online pharmacy — for a reported $1 billion.

Amazon doesn't have a monopoly on eCommerce, but they do enjoy a huge share of the pie. Just as importantly, their business model ushered in huge changes in customer expectations and omnichannel sales strategies when it comes to online selection and speed of delivery. All of the clues we mentioned seem to suggest that Amazon wants to use its influence to make significant changes to how pharmaceutical products are distributed, too.

When we try to catch a glimpse of the future of the pharmaceutical supply chain, it looks more and more like direct-to-patient and direct-to-hospital delivery will be the order of the day, for diagnostic tools and medical devices as well as for more time-sensitive medication purchases. Supply chain companies aren't going anywhere — indeed, the explosion in popularity of online pharmacies and even subscription-based business models likely means they'll be busier than ever — but wholesalers might slowly be squeezed out of the equation as tech giants like Amazon and others consolidate industry resources and reinvent consumer expectations.

No matter what, the cold chain will keep doing what it does best — getting pharmaceutical products into the hands of people who need them. But how it does so, and the tools it uses, are shaking up before our eyes.
Pharmaceutical Microbiology (c) Dr Tim Sandle http://www.pharmamicroresources.com
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