2018-07-09 12:00
Montana State University scientists have found a new lineage of microbes living in Yellowstone National Park's thermal features that sheds light on the origin of life, the evolution of archa… Read More
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Pharmaceutical Microbiology Blog
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pharmaceutical microbiology,quality assurance, healthcare, cleanroom, contamination control, microbiology, tim sandle, sterility, disinfection
2018-07-08 12:30
A study published this week in Nature sheds new light on the connection between the gut and the brain, untangling the complex interplay that allows the byproducts of microorganisms living in… Read More
2018-07-07 12:30
Scientists have developed a workflow that enables large-scale, genome-wide assays of gene importance across many conditions. The study, 'Mutant Phenotypes for Thousands of Bacterial Genes of… Read More
2018-07-06 12:30
An interesting article in The Atlantic on the use of the horse-shoe crab for manufacturing endotoxin test reagents.Some extracts of interest:“Every year, more than 400,000 crabs are bl… Read More
2018-07-05 12:00
Pore-forming toxins are bacterial poisons that destroy cells by creating holes in the cell membranes. Many bacterial pathogens produce such toxins, including, for example, some strains of th… Read More
2018-07-04 12:00
At its 161st Session, which took place in Strasbourg on 19-20 June 2018, the European Pharmacopoeia (Ph. Eur.) Commission adopted 10 new monographs, 1 new chapter, 92 revised monographs and… Read More
2018-07-03 12:30
Dietary fiber increases survival in influenza-infected mice by setting the immune system at a healthy level of responsiveness, according to a preclinical study published May 15 in the journa… Read More
2018-07-02 13:00
There are different types of microorganisms associated with medicinal product recalls, as a review of recall notices indicates. One of the major reasons for recalls, aside from Gram-negative… Read More
2018-07-02 08:58
Surely, most of our habits, characteristics, and features come from our parents, but there are certain things we call upon ourselves. For instance, over-eating, smoking, alcohol addiction, l… Read More
2018-07-01 11:30
On February 28, 2018, the Health Products Compliance Directorate posted four drug good manufacturing practices (GMP) documents to the Health Canada website. These documents are:Good manufact… Read More
2018-06-30 12:00
Factsheets cleanroom isolatesStandard microbiology text books are biased to medical bacteria. These factsheets provide pharmaceutical microbiologists with details on the most common isolates… Read More
2018-06-29 13:00
Historically, our view of host defense against infection was that we must eliminate pathogens to eradicate disease. However, this perspective has recently been challenged as scientists have… Read More
2018-06-28 12:30
The latest edition of Pharmig News has been issued (edition #71). In this issue:Update on Pharmig eventsReport from PHSS conference on Annex 1Pharmig’s response to the draft Annex 1Rev… Read More
2018-06-27 12:00
The US Food and Drug Administration (FDA) on Wednesday finalized its version of the addendum to the International Council for Harmonisation's (ICH) good clinical practice (GCP) guideline.The… Read More
2018-06-26 14:51
King Midas is remembered in Greek mythology for his ability to turn objects he touched into gold. Surprisingly, his strange ability is shared in reality by a certain species of bacteria call… Read More
2018-06-25 12:00
According to the World Health Organization (WHO), it is estimated that 2.3 billion people around the world have no access to safe, clean toilets, and where there are sanitation facilities, t… Read More
2018-06-24 12:00
As part of the Certification of Suitability procedure, the EDQM runs an inspection programme for API manufacturers and is committed to optimise the inspection resources as much as possible… Read More
2018-06-23 12:30
The MHRA have recently written about the sterility assurance concerns of hydrogen peroxide, especially around the issue of hydrogen peroxide vapour not being a penetrative method.This is in… Read More
2018-06-20 22:20
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… Read More
2018-06-20 11:30
In a new study, researchers report new insights into the regenerative capabilities of Stentor, a single celled model organism for regeneration biology. The study used novel gene expression m… Read More
2018-06-19 22:14
The European Medicines Agency (EMA) and the European Commission have updated their guidance to help pharmaceutical companies prepare for the United Kingdom’s (UK) withdrawal from the E… Read More
2018-06-19 12:30
Northwestern microbiome project to launch June 29 for International Space Station. Studies of twin mice and twin men aim to discover effects of space on body’s microbiomeTwenty laborat… Read More
2018-06-18 17:41
USP plans to launch the new USP–NF Online product on June 18, 2018Below is an updated list of new features for the new USP–NF Online:NEW feature: Accelerated Revisions such as Er… Read More
2018-06-18 12:30
Many laboratory managers have given attention to automated, digital devices to streamline the plate counting processes. Such devices have been commonplace to the clinical laboratory for some… Read More
2018-06-16 13:00
Manufacturers of cell-culture-based therapeutics can now rely on a faster method for detecting mycoplasma contamination. The Applied Biosystems MycoSEQ Mycoplasma Detection Kit is a fully in… Read More
2018-06-15 12:30
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance entitled “Definitions of Suspect Product and Illegitimate Product for Verification O… Read More
2018-06-14 12:00
FDA has issued a new guidance of interest. This guidance is intended to assist trading partners in standardizing the data contained in the product tracing information that trading partners m… Read More
2018-06-13 22:38
Is your lifestyle costing your health? According to an article published in the Center for Science in the Public Interest, a sedentary lifestyle and unhealthy eating habits are the leading c… Read More
2018-06-13 13:00
You’ve identified an organism in your environment. Now what? If you work in a non-sterile pharmaceutical manufacturing laboratory, chances are you’ve encountered this question.Th… Read More
2018-06-12 12:30
Published in eLife, a paper presents a new mathematical model that can predict the effectiveness of microbiome therapies that manipulate the immune system through live bacteria.To the author… Read More
2018-06-11 12:00
A study by scientists at the Center for Infection and Immunity (CII) at Columbia University's Mailman School of Public Health finds New York City house mice carry bacteria responsible for mi… Read More
2018-06-10 12:30
A new study by scientists at the University of Liverpool documents, for the first time, how the ability of bacteria to swap genetic material with each other can directly affect the emergence… Read More
2018-06-09 12:00
Listeria costaricensis is the official name given to the new bacterial species described by investigators from the Costa Rican Institute of Technology (TEC) and the WHO-collaborating ce… Read More
2018-06-08 12:30
A large proportion of malaria patients in endemic countries in Africa are likely to receive doses of malaria medicine that are too low to offer effective treatment, according to new research… Read More
2018-06-07 12:00
A new study suggests that in certain areas of sub-Saharan Africa, nearly one in four blood bank supplies contain the parasites that cause malaria. Another study, focusing on the blood supply… Read More
2018-06-06 12:00
The question of calibration frequently arises with a new balance, and the answer is simple: most manufacturers recommend calibration before the first use. And if you use your balance at all… Read More
2018-06-05 13:00
The bile solubility test is used to determine the ability of bacterial cells to lyse in thepresence of bile salts, within a specified time and temperature.S. pneumoniaepossesses an autolytic… Read More
2018-06-04 22:12
Smarter pharmaceuticals and pharmacovigilance are transforming the healthcare space. But what exactly is “smart pharma” and how are these digital technologies transforming and be… Read More
2018-06-04 13:00
In the past ten years there have been several advances in single-use sterile, disposable technologies, such as bag chambers, connectors, tubing, filling needle manifolds, and filter capsule… Read More
2018-06-03 12:30
Pharmeuropa 30.2 carries a revised draft monograph for “Particle contamination (visible parties)”. This is monograph 2.9.20. The primary changes are:Clarification of: the introdu… Read More
2018-06-02 12:30
Pharmeuropa 30.2 carries a revised draft monograph for “Microbiological examination of cell based preparations”. This is monograph 2.6.27. In terms of scope: “The approache… Read More
2018-06-01 11:00
News from EDQM: Since the adoption of the first version of the “Validation of Computerised Systems” guideline in May 2009, most of the Network members have introduced computerise… Read More
2018-05-31 13:00
Cleanrooms have meticulous levels of contamination (ISO Class) specified by the number of particles per cubic meter at a specified particle size. Air entering a cleanroom from the outside mu… Read More
2018-05-30 13:00
The catalase test is used to detect the presence of catalase enzyme by the decomposition of hydrogen peroxide to release oxygen and water as shown by the following reaction:2 H2O2 → 2H2… Read More
2018-05-29 13:00
A comparison of several sterile processing techniques, including aseptic isolators, restricted access barrier systems and aseptic Split Butterfly Valve technology has been undertaken by Chri… Read More
2018-05-28 12:30
The December 2017 draft of EU GMP Annex 1 carries implications for cleanrooms. In a new article, Tim Sandle assesses the impact on cleanrooms and controlled environments. The article appears… Read More
2018-05-27 13:00
The test is used primarily as a supplementary presumptive test to distinguish pathogenic staphylococci which produce large quantities of extracellular DNase. The DNase reacts with media cont… Read More
2018-05-26 12:30
Coagulase is a protein enzyme produced by several microorganisms that enables the conversion of fibrinogen to fibrin. Coagulase binds plasma fibrinogen, causing the organisms to agglutinate… Read More
2018-05-25 12:30
Consumers have high concerns about what they buy and environmental labels and declarations can help them identify those products or services proven “environmentally preferable”.N… Read More
2018-05-24 22:44
Pyrogen Detection: Want to stop using animal based methods and get higher sensitivity? Ready-to-use PyroMAT™ in vitro system We are glad to inform you that our new in vitro s… Read More
2018-05-24 13:00
Nosopharm, a company dedicated to the research and development of new anti-infective drugs, and the University of Illinois at Chicago (UIC) today announce the publication of a study in Molec… Read More
2018-05-23 12:00
Researchers have developed a process for creating ultrathin, self-assembling sheets of synthetic materials that can function like designer flypaper in selectively binding with viruses, bacte… Read More
2018-05-21 13:00
Tim Sandle has written an article for the website sterilize.it, the article covers:This article considers some of the risk considerations that need to be accounted for when replacing a steam… Read More
2018-05-20 12:00
Researchers at RMIT University have developed a new artificial enzyme that uses light to kill bacteria. The artificial enzymes could one day be used in the fight against infections, and to k… Read More
2018-05-19 12:00
One of the biggest threats comes from carbapenemases, molecules that can make microbes impervious to carbapenems, which are some of the most potent antibiotics. The Enterobacteriaceae family… Read More
2018-05-18 12:00
To learn about the past, paleontologists turn to the fossil record. The occurrence, abundance and diversity of fossils provides a window into the evolutionary history of animal and plant gro… Read More
2018-05-17 11:30
Bioengineers have figured out a way to make noscapine, a non-narcotic cough suppressant that occurs naturally in opium poppies, in brewer's yeast. The researchers inserted 25 foreign genes i… Read More
2018-05-16 13:00
Infection prevention and control (IPC) and antibiotic stewardship (AS) programs are inextricably linked, according to a joint position paper published today by the Association for Profession… Read More
2018-05-15 12:30
Scientific recipes have been developed to successfully grow and study gut bacteria in the lab Researchers report on the nutritional preferences and growth characteristics of 96 diverse gut b… Read More
2018-05-14 12:00
The PDA has published a new e-book series on risk assessment and risk manageement. Tim Sandle has authored the fourth volume is the series.The reference is:Sandle, T. (2018) Risk Management… Read More
2018-05-13 12:30
Working with light and genetically engineered bacteria, researchers from Stanford University are able to shape the growth of bacterial communities. From polka dots to stripes to circuits, th… Read More
2018-05-12 12:30
Bacteria produce proteins to take out specific competitors. One of these proteins can kill the hospital bacterium Pseudomonas aeruginosa. Microbial geneticists have unraveled how this protei… Read More
2018-05-11 12:00
Bacteria can grow on stainless steel surfaces, contaminating food. Current coatings available on the market are pricey and potentially harmful, so scientists have now developed an affordable… Read More
2018-05-10 12:00
A new Journal of Internal Medicine article proposes that artificial intelligence tools, such as machine learning algorithms, have the potential for building predictive models for the diagnos… Read More
2018-05-09 12:30
Chapter is arguably one of the most comprehensive informational chapters from the USP, and it is particularly challenging due to its proposal regarding measurement of microbial contaminatio… Read More
2018-05-08 13:00
Outsourcing to contract manufacturers can be a valuable, even critical, option allowing companies to focus their resources and talents on their primary objectives. In many cases, having othe… Read More
2018-05-07 12:30
This article examines the different characteristics between apoptosis and necrosis, two morphologically distinct manifestations of cell death. Necrosis is non-genetic and triggered by extern… Read More
2018-05-06 12:30
Researchers have used a combination of light and genetic engineering to controlling the metabolism, or basic chemical process, of a living cell. Building on techniques that already have tran… Read More
2018-05-05 12:30
Ahead of World TB Day 2018, the Foundation for Innovative New Diagnostics (FIND) has made two announcements: Jointly with the South African Medical Research Council (SAMRC), FIND announced a… Read More
2018-05-04 12:00
Bacteria embedded in the biofilm are more difficult and expensive to eliminate, than free-floating planktonic bacteria. Their presence in manufacturing pipelines can be responsible for a wid… Read More
2018-05-03 18:25
A recording of Pharmig's response to draft EU GMP Annex 1, hosted by Tim SandleSee: Annex 1 overviewPosted by Dr. Tim SandlePharmaceutical Microbiology (c) Dr Tim Sandle
http://www.pharmamic… Read More
2018-05-03 12:30
PVDF (PVF2 or Polyvinylidene fluoride or polyvinylidene difluoride) is a semi-crystalline, high purity thermoplastic fluoropolymer.News from Omnexus.With service temperatures up to 150°C… Read More
2018-05-02 12:30
Researchers made an important step toward deeper understanding of how malaria blood stage parasites turn the switch to become transmissible to other humans. This knowledge is fundamental for… Read More
2018-05-01 12:30
Fungi forming mold on food are hazardous. Fungi supplying antibiotics are beneficial. Fungi may be harmful pathogens. On the other hand, they are used for the production of food or medicine… Read More
2018-04-30 12:30
A new book of interest: "Phase Appropriate GMP for Biological Processes: Pre-clinical to Commercial Production", edited by Trevor Deeks.The book provides succinct and practical guidanc… Read More
2018-04-29 13:00
Researchers are developing a promising alternative to antibiotic treatment for infections caused by Klebsiella pneumoniae bacteria resistant to carbapenem antibiotics. The approach uses anti… Read More
2018-04-28 13:00
Standard practices for the infectious diagnostics require up to 72 hours to allow for a reliable result. This is due to the fact, that the number of pathogens in a patients sample is too sma… Read More
2018-04-27 13:00
Bacteria have developed resistance to most of the drug compounds we use today. Examples of multi-drug resistant bacteria include organisms that are part of our normal microbiome and thus har… Read More
2018-04-26 12:30
A new research paper of interest - "Matrix-assisted laser desorption ionization–time of flight mass spectrometry for identification of bacteria isolated from pharmaceutical clean rooms… Read More
2018-04-25 19:56
Preemptive Steps Taken by FDA Seen As Disrupting Kratom Supplies and Forcing Reliance on “Substandard” Product; Salmonella Issue Shows Need for Properly Regulated Marketplace, No… Read More
2018-04-25 12:00
During its 159th plenary session, the European Pharmacopoeia Commission endorsed the complete suppression of the test for abnormal toxicity from the European Pharmacopoeia (Ph. Eur.).As part… Read More
2018-04-24 19:28
Each year, the World Health Organization (WHO) uses World Immunization Week, celebrated during the last week of April, to promote awareness of the countless benefits of vaccines, which are u… Read More
2018-04-24 13:00
Researchers have designed sugar molecules that block E. coli bacteria from binding to urinary tissues, allowing the bacteria to be washed out of the urinary tract. The compounds represent a… Read More
2018-04-23 12:30
Microbial control of pharmaceutical water systems is not only about numbers of microorganisms estimated to be present, as recovered through bioburden testing of a given volume of sampled wat… Read More
2018-04-22 13:00
Bacteria found in the small intestines of mice and humans can travel to other organs and trigger an autoimmune response, according to a new study.The findings suggest promising new approache… Read More
2018-04-21 13:00
The U.K. Government’s new Office for Product Safety and Standards has teamed up with BSI to launch the first Government-backed Code of Practice (PAS 7100) for product safety related re… Read More
2018-04-20 13:00
In 1854, John Snow's work on cholera in London immortalised the power of mapping as a tool for disease prevention and control. Over 160 years later, a more ambitious effort to map cholera ha… Read More
2018-04-19 12:30
British Standards Instiutte (BSI) has consulted its members and stakeholders about the possible implications of Brexit for standards. The BSI Brexit Position Statement sets out the eight key… Read More
2018-04-19 10:00
Over the past decade, the number of pharmaceutical product recalls due to fungi has increased significantly, with many different product groups affected. Data suggests a link between product… Read More
2018-04-18 13:00
Bacterial spores store information about the individual growth history of their progenitor cells, thus retaining a "memory" that links the different stages of the bacterial life cycle. This… Read More
2018-04-17 13:00
Exposure to psychological stress in the form of social conflict alters gut bacteria in Syrian hamsters, according to a new study by Georgia State University. It has long been said that human… Read More
2018-04-16 13:00
The larva of the sleeping chironomid, Polypedilum vanderplanki -- a mosquito-like insect that inhabits semi-arid areas of Africa -- is well known for being able to come back to life after be… Read More
2018-04-15 20:04
The CDC, the FDA, several states, and U.S. Department of Agriculture’s Food Safety and Inspection Service are investigating a multistate outbreak of Shiga toxin-producing E. coli O157… Read More
2018-04-15 17:25
The European Pharmacopeia intends to assess the following during 2018:2.6.40. Monocyte-activation test for vaccines containing inherently pyrogenic components5.26. Implementation of pharmaco… Read More
2018-04-14 12:00
A new FDA guidance document of interest has been issued. The title is “Microbiology Data for Systemic Antibacterial Drugs — Development, Analysis, and Presentation Guidance for I… Read More
2018-04-13 12:30
The European Medicines Agency has published its work plan for 2018:“The activities outlined in the work plan for 2018 have been agreed in view of preparation for the Agency’s rel… Read More
2018-04-12 12:31
Bacteria could be programmed to efficiently produce drugs, thanks to breakthrough research into synthetic biology using engineering principles, from the University of Warwick and the Univers… Read More
2018-04-11 12:00
Scientists have developed a new therapy to combat deadly bacteria that is infecting hospital patients worldwide.The new therapy—a biocide that is able to target antibiotic-defiant bact… Read More
2018-04-10 12:30
The framework guides complex bioengineering tasks between multiple cell populations.Researchers have created a framework for helping bioengineers determine when to use multiple lines of cell… Read More
2018-04-09 19:01
Researchers have constructed a textile-based, bacteria-powered biobattery. The aim of the flexible battery is for incorporation into wearable electronic devices. The invention of the battery… Read More
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