Melvyn Bragg and guests discuss penicillin, discovered by Alexander Fleming in 1928. It is said he noticed some blue-green penicillium mould on an uncovered petri dish at his hospital laboratory, and that this mould had inhibited bacterial growth around it. After further work, Fleming filtered a broth of the mould and called that penicillin, hoping it would be useful as a disinfectant. Howard Florey and Ernst Chain later shared a Nobel Prize in Medicine with Fleming, for their role in developing a way of mass-producing the life-saving drug. Evolutionary theory predicted the risk of resistance from the start and, almost from the beginning of this 'golden age' of antibacterials, scientists have been looking for ways to extend the lifespan of antibiotics.
European Pharmacopoeia (Ph. Eur.) Commission has decided to elaborate a new
general chapter on microbiological control of tissue. The aim of the survey is
to gather information from relevant stakeholders to enable the Ph. Eur. experts
in charge of the elaboration of this chapter to have a clear vision on the
current situation regarding the characteristics of tissue preparations used in
Europe and how they are monitored with regard to microbiological control.
from the Center of International Forestry Research, Manchester Metropolitan
University, and the Universidad de Málaga have applied analytical techniques
that indicate where the Ebola virus is likely to be found in more favorable
conditions. These models take into account a number of non-human mammalian
species as well as environmental variables for predicting the presence of the
assuming that more mammalian species than simply fruit bats may be involved in
its presence and spread, the map suggests that the Ebola virus may be even more
widespread than formerly suspected. The map indicates
that more favorable areas for the virus extend throughout the coastal areas of
West and Central Africa, stretching from Cameroon to Guinea and into the East
into the East African Lakes region.
further details see:
Jesús Olivero, John E. Fa, Raimundo Real,
Miguel Ángel Farfán, Ana Luz Márquez, J. Mario Vargas, J. Paul Gonzalez, Andrew
A. Cunningham, Robert Nasi. Mammalian biogeography and the Ebola virus
in Africa. Mammal Review, 2016; DOI: 10.1111/mam.12074
Pharmaceutical Technology's new eBook
addresses a range of pressing bioprocessing and sterile manufacturing topics.
Features include a report on accelerated
scale-up for vaccine production, a review of the new ISO 1464 Parts 1 and 2
standards for air cleanliness classification, aseptic filling advances, a
flexible approach to cleanroom design, a science-driven approach for microbial
control, removing genotoxic impurities, regulatory enforcement and drug
shortages, and qualification and validation of single-use shipping systems.
Pain leaves its sufferers disabled and socially isolated. There is no doubt that it requires treatment. However, treatment usually means the use of opioid drugs, and while they are the most effective drug to treat it, they are also terribly addictive.
A guest post by Megan Ray Nichols
Some Prescription Drugs Are Chemically Similar to Narcotics
Opioids are a synthetic drug that inhibits the brain and body’s ability to feel pain. Chemically, they are remarkably similar to the predecessor of which it is a derived from, namely, the opium poppy, which is also used to produce heroin and morphine — some of the most addictive substances on Earth.
Both chemists and physicians know better, though. There just aren’t many alternatives in terms of drug therapy for sufferers yet.
Addiction Isn’t Always Obvious
And the images portrayed by many public health campaigns and anti-drug ads are misleading, further damaging efforts to really help those struggling with drug abuse. People who are addicted to drugs do not always look like the face-picking, emaciated “meth-head” that is so often depicted in the media — they can be highly functioning and successful people like bankers, pop stars, or your neighbors.
The inaccurate portrayal of addiction can lead people into a false sense of security in believing that they are in control of their habits, but like some of those famous aforementioned examples, denial of their drug addiction led to death. This is why if you or someone that you know is suffering from addiction, it’s important to seek help as soon as possible. Almost six percent of young adults report abusing prescription drugs — they are an especially important demographic because of the life-altering implications of substance abuse starting from an early age. The sooner you end the cycle of drug abuse, the easier recovery will be.
More Prescriptions Correlates to More Addiction
There are no easy solutions to this problem, but we can at least explore why prescription drug abuse has increased so much in recent years in the United States. Without understanding the origins of the problem, it’s unlikely we’ll find a proper fix. To be as simple as possible, the prescription drug crisis has its roots in the common availability of pain medication that was once far more strictly regulated. Opioids such as heroin have long been used in to relieve pain. But they were mostly used for the most extreme situations.
However, as recounted in the National Review, all of this changed in the 1980s, when the medical industry began using them to relieve long-term pain. OxyContin, released in 1996, represented the culmination of this trend. The drug is a controlled release of oxycodone, a potent opioid cultivated from the Persian poppy. It was also around this time that more powerful drugs like Adderall started being prescribed to “cure” hyperactivity.
Many quickly became addicted. Patients wouldn’t believe that something from a doctor could be harmful. This went on for an extended period of time for several reasons.
Authorities have, of course, cracked down in some ways on the over-prescription of legal prescription drugs. However, instead of taming that problem, it has created a huge and lucrative black market for prescription drugs as well as related drugs like heroin — and regulating Mexican drug cartels or smugglers tends to be more difficult than US-based pharmaceutical companies.
Solutions to the Crisis Require Both Drug Research and Behavioral Change
Fortunately, there are some solutions on the horizon. For one, we should develop pain and ADHD therapies that do not require addictive drugs. This could mean the development of new medicines, or it could mean increased research into alternative therapies. We also need fair and accurate drug education campaigns. Depicting all drug addicts as people having erratic behavior and terrible appearances misleads people into thinking that they do not have any problems with substance abuse because they do not look like the stereotype.
Finally, the U.S. needs to de-stigmatize addiction therapy. It shouldn’t surprise anyone to see elderly or successful people undergoing rehabilitation for addiction treatment, nor should they be penalized in their work or social lives.
Prescription drug abuse is on the rise, and both medical practitioners and policy makers need to take steps to address this issue before more lives are affected.
U.S. Food and Drug Administration has produced a new guidance for industry of
interest. It is titled “Safety Considerations for Product Design to Minimize
recommendations in this guidance apply broadly to the development of drug and
biologic products. Accordingly, this guidance is intended for sponsors of
investigational new drug applications (INDs); applicants of new drug
applications (NDAs), biologics licensing applications (BLAs), abbreviated new
drug applications (ANDAs); and manufacturers of prescription drugs marketed
without an approved application or over-the-counter (OTC) monograph drugs. This
guidance provides a set of principles for using a systems approach to minimize
medication errors relating to product design and container closure design and
thus enhance patient safety.
recommendations in this guidance document are intended to provide best
practices on how to improve the drug product and container closure design for
all prescription and non-prescription drugs and biologic products regulated by
the Center for Drug Evaluation and Research (CDER), which are referred to
collectively in this guidance as products. The guidance also provides examples
of product designs that have resulted in postmarketing medication errors…”
activity is an established concept for food science, especially with the
assessment of food preservation and understanding which microorganisms might
present a risk to the manufacturing process in relation to particular
ingredients. Where there has been less research and discussion is with effect
of water activity and appreciating the risks in relation to pharmaceutical products.
highlight the importance of this, Tim Sandle has written a short review article
for the Journal of Pharmaceutical Microbiology.
T. The Importance of Water Activity for Risk Assessing Pharmaceutical Products,
J Pharm Microbiol. 2016, 2 (1): 1-2
The IP Erasmus Project Classic and Modern Methods for
Molecular Diagnostics in Human Pathology, coordinated by Transilvania
University of Braşov between 2011-2013 had a follow up in the
publication of a new volume. The book chapters were written or
coordinated by the Project partners, as well as by other collaborators,
interested both in the Project and in disseminating the results of their
a balance cleaned and maintained can dramatically increase the life of your
balance and the quality of your weighing results.
is the subject of an article by Michelle Sheridan, Weighing Specialist,
Sartorius Corporation, for Laboratory Network.
work steps, such as the measuring process itself, but also cleaning,
calibration and maintenance, should be described in your Standard Operating
Procedures (SOPs). Following your SOPs can mean that you will have consistent
and precise weighing results at all times. Sartorius balances can meet your
requirements for laboratory and production areas, and allow for easy and simple
cleaning. Care of the balance’s cleanliness reduces disturbances during the
liver cell damage by alcohol has been well established as one of the primary
causes of liver disease. Recent work by scientists at UC San Diego demonstrates
that, in addition, alcohol can lead to liver disease by causing an imbalance in
the gut microflora. Humans produce two natural broad-spectrum antimicrobial
proteins called REG3B and REG3G that surveil gut mucosal bacteria and prevent
overgrowth. Alcohol causes a down-regulation in the genes encoding for REG3B
and REG3G leading to bacterial overgrowth, an increase in microbial
translocation, immune activation and further cell damage, including the liver.
Mice with REG3B/REG3G knockouts have more severe liver disease while mice with
REG3G over-expression avoid liver damage. This work adds to the increasing
importance of gut health on a wide range of disease.
Eighteen months have passed since the MHRA published its GMP data integrity guidance. Since then we have seen pharmaceutical industry make significant effort to implement the guidance globally. It has been encouraging to see industry stakeholders and regulatory partners adopting a common approach in their own publications and the messages and themes being echoed in online discussions, workshops and conference presentations.
David Churchwood has written an interesting post on the latest data integrity developments.
Here is an extract:
"During this busy period we have also been working on the next phase of MHRA guidance, which has a GxP focus (good laboratory practice, good clinical practice, good manufacturing practice, good distribution practice and good pharmacovigilence practice). Data integrity is important throughout the pharmaceutical lifecycle, and GxP regulatory requirements have a common focus of requiring confidence in the quality and the integrity of the data used for decision-making."
Here is a link to the new MHRA consultative document: MHRA data.
it comes to being prepared for an inspection from a regulatory authority, the
combination of practice and preparation will often make the difference between
success and failure.
Manufacturing are hosting a useful article by Joachim del Boca on regulatory
is an extract:
agencies are increasing their vigilance on the (bio-)pharmaceutical industry
with greater scrutiny placed upon aseptic manufacturing facilities. Perhaps one
of the most significant changes in this attentiveness has been in the area of
data integrity. A recent increase in the number of incidents where a company’s
data was falsified or poorly documented has led to new regulations.”
into a solid wall at 670 miles per hour doesn’t even leave a mark. Brigham
Young University Chemistry professor Daniel Austin and his graduate students
are learning just how hard it can be to kill bacteria.
research group, funded by NASA, is studying high velocity impact of bacterial
spores. More specifically, the group is trying to find the speed limit above
which bacteria won’t survive when they crash into a hard surface.
should be a velocity at which they’ll splat and die, but we haven’t reached
it,” Austin says. “We can get pretty close to the speed of sound, and we’re
planning to go to higher velocities in the near future, but it’s not easy to
test velocity, bacteria are loaded into a vacuum chamber and then launched by a
blast of air at speeds nearing 300 meters per second.
group’s recently published study in Planetary and Space Science is the first of
its kind to test the impact survivability rate of bare bacteria.
the main focus of the research is answering the question of how much force
the bacteria can withstand, NASA has funded the research because of the
planetary protection implications of the study: if bacteria can survive the
ejection from one planet and the impact of landing on another planet, there are
potential concerns about cross contamination of bacteria between those planets.
However, Austin is quick to acknowledge that there are other factors, like UV
light, that may kill the bacteria in transition.
though the initial publication’s lead authors Brandon Barney and Sara Pratt
have graduated, Austin continues to mentor current students as they develop the
research. The group is now collaborating with Microbiology professor Richard
Robison as they continue the quest for higher impact speeds. They anticipate
that blasting bacteria at one kilometer per second (more than 2,200 miles per
hour) should be more than enough to kill the bacteria, but the group hasn’t yet
been able to create those speeds in the lab.
seem so frequently surprised at what bacteria can survive, and this just adds
to the list,” Austin says. “Our understanding of the limits of life have
expanded a lot since the 1970s as we find bacteria surviving and even thriving
under extreme conditions.”
testing the limits of bacteria, Austin’s team has additionally observed an
unusual elasticity of the bacterial spores, which may have potential
applications in nanotechnology.
allows better and quicker germ identification and health response, in some news
from the U.S. Centers for Disease Control (CDC).
has heard of common germs like E.coli
or influenza, but what about Streptobacillus
moniliformis or Capnocytophaga?
If not treated quickly, both can kill people within days. But they are so rare
that doctors and labs probably have never seen them and may mistake them for
more common diseases like meningitis. Enter MicrobeNet, an innovative online
tool designed by the Centers for Disease Control and Prevention (CDC) that,
since 2013, has helped laboratorians and doctors get the information they need
to accurately diagnose causes of disease faster and save lives.
provides laboratorians with unprecedented access to CDC's virtual microbe
library of more than 2,400 rare and emerging infectious bacteria and fungi at
no cost. The recent multi-state outbreak of Elizabethkingia
in Wisconsin, Illinois and Michigan underscores the need for a tool like
MicrobeNet in diagnostic laboratories. Hospitals and health departments using
MicrobeNet can identify rare bacteria like Elizabethkingia
quicker, and know they’re comparing their results to the most comprehensive and
accurate disease database available.
partnership with Bruker Corp., CDC has recently added a new module to
MicrobeNet that allows labs to search the protein signatures of the bacteria
and compare them to the rare pathogens in CDC's MicrobeNet library by using
Bruker's MALDI Biotyper systems. Using MALDI to test is extremely fast and cheaper
to run than many other types of testing, making the technology increasingly
popular among labs. The new MicrobeNet module will be immediately available to
laboratorians and clinicians using the Bruker system in labs nationwide. Until
the addition of the MALDI library, MicrobeNet offered two ways to search
pathogens: by DNA sequence or biochemical tests (chemical reactions caused by
can dramatically improve the health of people in the United States and around
the world by cutting the time for testing from about a week to a few hours.
has the potential to revolutionize public health," said John R. McQuiston,
PhD, team lead for CDC's Special Bacteriology Reference Laboratory and CDC's
lead for MicrobeNet. "This system helps public health labs and hospitals
quickly identify some of the most difficult pathogens to grow and detect. In
turn, MicrobeNet will help treat patients faster and allow health departments
to respond to public health emergencies more effectively."
The New York City report of female-to-male
sexual transmission of Zika virus infection is the first documented case of
sexual transmission of Zika from a woman to her sex partner and adds to the
growing body of knowledge about the sexual transmission of Zika. All previously
reported cases of sexually transmitted Zika virus infection have been spread
from men to their sex partners.
News from the U.S. Centers for Disease Control and Prevention (CDC):
CDC recommends that
all pregnant women who have a sex partner who has traveled to or resides in an
area with Zika use barrier methods every time they have sex or they should not
have sex during the pregnancy. Although no cases of woman-to-woman Zika
transmission have been reported, these recommendations now also apply to female
sex partners of pregnant women.
CDC is currently
updating recommendations for sexually active people in which the couple is not
pregnant or concerned about pregnancy and for people who want to reduce
personal risk of Zika infection through sex.
microbiological method technologies aim to provide more sensitive, accurate,
precise, and reproducible test results when compared with conventional,
growth-based methods. Rapid methods normally involve some form of automation
and the methods often capture data electronically. With several different
technologies available on the marketplace, the microbiologist has a difficult, and
sometimes expensive, choice to make in selecting the optimal method. This
article outlines some of the considerations that need to be considered for
reference for the article, by Tim Sandle, is:
T. (2016) Key Criteria for the Selection of Rapid and Alternative Microbiological
Methods, American Pharmaceutical Review,
19 (3): 46-48