Wednesday, 28 February 2018

Advances in Science Equipment


Adoption of new tech trends can increase efficiency in laboratories. It enables researchers and scientists to obtain more reliable and accurate data than ever before. For example, communication efficiency increases the speed in which tests are completed and reduces operating costs. Below are some of the expected tech trends in the lab equipment world.

A guest post by Joe Humphries

Equipment Automation

While lab equipment automation is not a new trend, it continues to advance and spread across other fields of science. Technological advancements continue to bring more efficiency in applications and functions. Lab technicians can now use a microscope to complete several different tasks. Equipment automation has enabled lab technicians to eliminate repetitive experimental steps and reduce time wastage. It is now possible to generate results in a fraction of the time taken to complete an experiment. As such, lab technicians can now spend much of their time on data analysis rather than keeping data records. Lab technicians and scientists apply automation in areas such as genomics, screening, proteomics, and robotics. Researchers are using automation tools to meet their needs throughout the entire research process and even outside of the lab.

Cloud-Based Data Storage

The latest lab equipment is allowing scientists and lab technicians to record data and stores it in the cloud. They use the same devices to receive notification when something goes wrong. Real-time monitoring is fundamental to a controlled laboratory environment. The results of unregulated lab environment often lack reliability and accuracy. Even a slight change in temperatures can alter the entire results. Today, modern freezers notify lab technicians on their smartphone when there is an unanticipated temperature change. Scientists can also use computers or smartphones to monitor an experiment from any location. Furthermore, cloud technology allows lab technicians to share their study findings faster than ever before. Scientists in different labs can use cloud technology to upload and access research data. The ability to communicate allows scientists to work collaboratively and increase data reliability.

Proper Utilization of Resources


The field of scientific research is one of the areas affected by growing environmental concerns. The amount of energy consumed by research labs tends to be approximately five times more than that of a regular office. However, the latest lab tech trends have enabled researchers and lab technicians to utilize resources efficiently. Labs all over the world have upgraded to the most recent technology to allow researchers to share lab resources and equipment. Open labs enable scientists around the globe to access lab equipment at a reduced cost.

Over time, scientific labs have become eco-friendlier. They use recycled equipment as a way of keeping up with environment, health and safety guidelines. That has reduced the cost of equipment significantly and kept the environment safer for habitation. Furthermore, the latest technologies allow lab technicians to determine the exact amount of consumables required to complete an experiment. Consequently, costs and resource wastage have reduced significantly.

Development of Tiny Lab Equipment

Over time, tiny lab equipment is being developed to replace the old ones. As a result, lab technicians will save a lot of space in the laboratories. For example, fluidic components have replaced a series of valves and pumps that could be used to store specimen. The new technology has made it easier for scientists to use smaller amounts of sample. With the use of small valves, researchers can avoid sample contamination.

Conclusion

Increased access to the latest lab equipment has enabled greater collaboration than ever before. Researchers and lab technicians can now cut costs and streamline procedures through lab automation and adaptation of sustainable environmental practices. Tech trends are growing at a rapid rate, meaning scientists can obtain experimental results faster and efficiently.

Joe Humphries is a contributing writer and media specialist for Microbial Insights. He regularly writes for science blogs. See: http://microbe.com/

Improving sanitation


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

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

See: ISO

Posted by Dr. Tim Sandle

Tuesday, 27 February 2018

New edition of ISO/IEC 17025


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

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

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

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

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

What are the main changes in the 2017 version?
  • The scope has been revised to cover testing, calibration and sampling associated with subsequent calibration and testing.
  • The process approach now matches that of newer standards such as ISO 9001 (quality management), ISO 15189 (quality of medical laboratories) and ISO/IEC 17021-1 (requirements for audit and certification bodies).
  • The standard has now a stronger focus on information technologies and incorporates the use of computer systems, electronic records and the production of electronic results and reports.
  • A new chapter introduces the concept of risk-based thinking.
See: ISO



   Posted by Dr. Tim Sandle

Monday, 26 February 2018

Pharmaceutical Water Systems: Temperatures of Operation and Maintaining Control


Pharmaceutical water systems can be divided, amongst other criteria, into hot and cold systems. Many purified water systems are cold systems, subject to periodic chemical or ozone sanitization; whereas the water of highest (and thus greatest criticality) - Water-for-Injections (WFI) - tends to be a hot system. WFI is produced by either distillation (Vapor Compression Distillation or Multiple Effect Distillation), or by reverse osmosis. WFI is used for the preparation of parenteral medicines, dialysis and irrigation solutions. Large volumes are also consumed by the biotechnology industry for the preparation of cell culture media. The objectives of water purification are three fold:

To reduce the levels of the chemical components in the water to prevent interactions with the drug substance, and to prevent toxicity to the patient. Toxicity is possible when large volumes are either infused or used in conjunction with dialysis.
To reduce the microbial bioburden to the specified levels and to prevent further proliferation.
To remove endotoxins and to prevent their future accumulation.

On this subject Tim Sandle has written a paper. The reference is:

Sandle, T. (2017) Pharmaceutical Water Systems: Temperatures of Operation and Maintaining Control, Journal of GXP Compliance, 21 (6), 11-20: http://www.ivtnetwork.com/article/pharmaceutical-water-systems-temperatures-operation-and-maintaining-control

For further details see: IVT

Posted by Dr. Tim Sandle

Sunday, 25 February 2018

Tracing the evolution of E. coli


A team from the University of Delaware and University of California, San Diego recently uncovered new insights about how E. coli bacteria mutate in response to a life-threatening challenge.

To do this, the team brought together two experimental methods that aren't typically used in tandem: whole-genome sequencing and metabolic flux analysis.

At UC-San Diego, Adam Feist, an associate project scientist in bioengineering, and Bernhard Palsson, the Galletti Professor of Bioengineering, modified and then evolved ten strains of E. coli bacteria. They knocked out the bacterial cells' ability to utilize phosphoglucose isomerase, an enzyme that plays a critical role in the metabolism of glucose, a sugar. Robbing E. coli cells of the phosphoglucose isomerase enzyme is akin to starving them, stunting their growth by 80 percent.

However, as these E. coli cells evolved and multiplied, they eventually recovered between 46 and 71 percent of their growth rate.

The research team then used genomic analysis and flux analysis to figure out how the cells mutated and adapted to recover.

See:

Christopher P. Long, Jacqueline E. Gonzalez, Adam M. Feist, Bernhard O. Palsson, Maciek R. Antoniewicz. Dissecting the genetic and metabolic mechanisms of adaptation to the knockout of a major metabolic enzyme inEscherichia coli. Proceedings of the National Academy of Sciences, 2018; 115 (1): 222 DOI: 10.1073/pnas.1716056115

Posted by Dr. Tim Sandle

Saturday, 24 February 2018

New EudraVigilance system


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

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

See: EudroVigillance

Posted by Dr. Tim Sandle

Friday, 23 February 2018

Microbes on the skin promote tissue healing and immunity


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

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

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

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

See:

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

Posted by Dr. Tim Sandle

Thursday, 22 February 2018

Some flu virus mutations compensate for fitness costs of other mutations


Seasonal flu viruses continually undergo mutations that help them evade the human immune system, but some of these mutations can reduce a virus's potency. According to new research, certain mutations in the genome of influenza A may help counteract the weakening effects of other mutations.

nfluenza A causes tens of thousands of deaths in the U.S. every year, despite vaccination efforts. It persists, in large part, due to continual changes in the sequence of amino acid "building blocks" that make up the viral protein hemagglutinin, enabling it to avoid recognition and removal by immune system antibodies. Many of these mutations can reduce a virus's fitness -- its ability to make more copies of itself -- raising the question of how viruses compensate to recover their mojo.

Ivan Kosik of the National Institute of Allergy and Infectious Diseases, Maryland, and colleagues investigated hemagglutinin mutations to better understand the mechanisms by which influenza A viruses maintain fitness despite continual mutation. They focused on influenza A variants with mutations that enabled them to escape antibodies from mice, guinea pigs, or chickens.

To identify the accumulated mutations that restored viral fitness, the researchers sequenced the viral RNA using a supersensitive method called PrimerID sequencing, which enables tracking of all individual viral genomes so that any relevant mutations can be spotted. They found several mutations of particular interest that add a new sugar molecule to the hemagglutinin, thus creating a novel "N-linked glycan" site.

How does this help the virus to replicate? It turns out, that the new sugar allows the virus to regain "Goldilocks" binding to the host cell: not too weak, but not too tight either. In escaping the immune system, the new mutations can inadvertently disrupt this golden binding point, which can be remedied by adding a sugar molecules in the just the part of the hemagglutinin.

See:

Ivan Kosik, William L. Ince, Lauren E. Gentles, Andrew J. Oler, Martina Kosikova, Matthew Angel, Javier G. Magad├ín, Hang Xie, Christopher B. Brooke, Jonathan W. Yewdell. Influenza A virus hemagglutinin glycosylation compensates for antibody escape fitness costsPLOS Pathogens, 2018; 14 (1): e1006796 DOI: 10.1371/journal.ppat.1006796

Posted by Dr. Tim Sandle

Wednesday, 21 February 2018

First stem cells created using CRISPR genome activation


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

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

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

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

See:

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

Posted by Dr. Tim Sandle

Tuesday, 20 February 2018

MHRA on Brexit



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

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

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

The UK intends to agree a time-limited implementation period with the EU, and both parties have recognised its importance. Should however there be no implementation period,
MHRA’s approach would be in line with the following principles:

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

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

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

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



Posted by Dr. Tim Sandle

Monday, 19 February 2018

Distribution of Particles Within the Cleanroom: A Review of Contamination Control Considerations


The most important contamination control issue within cleanrooms is air, given that air can distribute contamination around the cleanroom, as well as the way that particles behave in air in relation to a tendency to settle. With this regard particles should not be thought of as 'passive' contaminants. Hence the essential part of cleanroom design is through established principles designed to control airborne particles.

On this basis Tim Sandle has written a paper:

“While the mechanisms of particle control are, with reference to cleanroom design, well described and limits are in place for the permitted maximum concentration of particles in a defined volume of air (a cubic meter), the distribution of particles within a cleanroom and the likelihood of particles settling is not so well described. Moreover, measuring the concentration of particles in the air and calculating these as the cumulative number does not inform the cleanroom user as to what proportion of these particles are likely to settle out from the air onto a surface. In discussing particles, this paper is not so much concerned with sources of particle generation; instead the focus is on a less discussed subject: particle distribution within the cleanroom environment and the risks of particles settling onto surfaces.”

The reference is:

Sandle, T. (2017) Distribution of Particles Within the Cleanroom: A Review of Contamination Control Considerations, Journal of GXP Compliance, 21 (6), 1-10: http://www.ivtnetwork.com/article/distribution-particles-within-cleanroom-review-contamination-control-considerations

For details see: IVT

Posted by Dr. Tim Sandle

Sunday, 18 February 2018

Systemic antibacterial and antifungal drugs: susceptibility test interpretive criteria


A new document from the U.S. Food and Drug Administration (FDA):   The guidance describes FDA’s recommendations on (1) how to make these labeling changes for antimicrobial drugs with approved new drug applications (NDAs) or abbreviated new drug applications (ANDAs), (2) language to remove from the labeling of such drugs, and (3) labeling language to use for all antimicrobial drugs to reference the FDA’s Susceptibility Test Interpretive Criteria web page. 

Antimicrobial susceptibility testing is used to determine if certain microorganisms isolated from a patient with an infection are likely to be killed or inhibited by a particular antimicrobial drug.  Historically, susceptibility test interpretive criteria have been contained in the Microbiology subsection of antimicrobial drug labeling.  There have been significant challenges associated with ensuring that this information is up to date in antimicrobial drug labeling

See FDA

Posted by Dr. Tim Sandle

Saturday, 17 February 2018

Novel framework to infer microbial interactions


Inferring the underlying ecological networks of microbial communities is important to understanding their structure and responses to external stimuli. But it can be very challenging to make accurate network inferences. Scientists now detail a method to make the network inference easier by utilizing steady-state data without altering microbial communities.

"Existing methods require assuming a particular population dynamics model, which is not known beforehand," said Yang-Yu Liu, PhD, of the Channing Division of Network Medicine. "Moreover, those methods require fitting temporal abundance data, which are often not informative enough for reliable inference."

To obtain more informative temporal data, researchers have to introduce large perturbations to alter the microbial communities, which are not only difficult in practice but also potentially ethically questionable, especially for human-associated microbial communities. The new method developed by BWH investigators avoids this dilemma.

"The basic idea is very simple. If one steady-state sample differs from another only by addition of one species X, and adding X brings down the absolute abundance of Y, then we can conclude X inhibits the growth of Y," said Liu. The team showed that this simple idea can be extended to more complicated cases where steady-state samples differ from each other by more than one species. They verified that, if enough independent steady state data were collected from the microbial communities, then the microbial interaction types (positive, negative and neutral interactions) and the structure of the network could be inferred without requiring any population dynamics modeling. 

The method proposed by the team resembles other network reconstruction methods based on steady-state data, but unlike the previous methods, no perturbations are required to be applied to the system. Furthermore, a rigorous criterion was established by the team to check if any given steady-state data was consistent with the Generalized Lotka-Volterra (GLV) model -- a classical population dynamics model in ecology that mathematically describes the relationships between species. The team found that if the microbial community followed the GLV model, then the steady-state data could also be used to deduce the model parameters -- interspecies interaction strengths and growth rates.

The method was systematically validated using simulated data generated from different classic population dynamics models with various levels of complexity. Then it was applied to real data collected from four different synthetic microbial communities, finding that the inferred ecological networks either agree well with the ground truth or can predict the response of systems to perturbations.


Additional insights into microbial ecosystems will emerge from a better understanding of their underlying ecological networks. Inferring ecological networks of human-associated microbial communities using the method developed here will facilitate the design of personalized microbe-based "cocktails," as the authors write, to treat diseases related to microbial dysbiosis.

"I am quite excited about this method, because it may pave the way to mapping more complex microbial communities such as the human gut microbiota, which in turn will help us design better microbiome-based therapies," said Liu.

See:

Yandong Xiao, Marco Tulio Angulo, Jonathan Friedman, Matthew K. Waldor, Scott T. Weiss, Yang-Yu Liu. Mapping the ecological networks of microbial communitiesNature Communications, 2017; 8 (1) DOI: 10.1038/s41467-017-02090-2

Posted by Dr. Tim Sandle

Friday, 16 February 2018

Good Distribution Practice deficiency data


The UK MHRA has published its latest review on Good Distribution Practice (GDP) deficiency data.

The GDP Inspectorate has reviewed the GDP inspection deficiency data for 2016 to allow identification of:

·         Severity and frequency of deficiencies associated with EU GDP references;
·         High impact and high frequency issues.

The purpose of publishing the inspection deficiency data is to allow industry to perform its own assessment against the deficiency findings as part of self-inspection and continuous improvement activity.

See:MHRA



Posted by Dr. Tim Sandle

Thursday, 15 February 2018

Monoclonal antibody therapies for veterinary use


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

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

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

To access the guidance, see EMA.

Posted by Dr. Tim Sandle

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