New antibiotics effective without triggering resistance

Not only are they effective against Gram-positive and negative multi-resistant bacteria, they also appear not to trigger resistance when used to treat infection in mice. Such are the promises of the two new antibiotics created by Prof. Brice Felden and his team at the Inserm and Université de Rennes 1 'Bacterial Regulatory RNAs and Medicine' joint laboratory (U1230), in conjunction with a team from the Rennes Institute of Chemical Sciences (ISCR). This French advance could bring both fresh impetus and new possibilities for fighting antibiotic resistance worldwide.

Antibiotics have saved so many lives over the previous century of their use in humans that they are considered to be one of the major breakthroughs of contemporary medicine. Unfortunately, growing resistance is gradually rendering them ineffective, with the threat of catastrophic public health consequences should this trend continue much longer. The few new antibiotics being brought to market essentially consist of so-called me-too drugs -- meaning that they are derived from existing classes of antibiotics.

Researchers from Inserm and Université de Rennes recently identified a new bacterial toxin which they transformed into potent antibiotics active against various bacteria responsible for human infections, whether Gram-positive or negative. "It all started with a fundamental discovery made in 2011," explains Brice Felden, Director of the Bacterial Regulatory RNAs and Medicine laboratory in Rennes. "We realized that a toxin produced by Staphylococcus aureus whose role is to facilitate infection is also capable of killing other bacteria present in our body. What we had identified was a molecule with dual toxic and antibiotic properties. We thought that if we could separate these activities, we would be able to create a new antibiotic non-toxic to the body. A challenge that we accepted!"

READ MORE: How bacteria communicate

In conjunction with the team of ISCR chemist Michèle Baudy Floc'h, a new family of so-called peptidomimetics was synthesized. As their name suggests, these peptides are inspired by the existing natural bacterial peptides but have been shortened and modified. Out of the twenty molecules created, two proved effective against resistant Staphylococcus aureus and Pseudomonas aeruginosa in mouse models of severe sepsis or skin infection. In addition, no toxicity to the other cells and organs, whether in animals or human cells was observed. These new compounds are well tolerated at their active doses -- and even beyond -- and are devoid of the renal toxicity issues often encountered with this type of compound. "We tested them at doses 10 to 50 times higher than the effective dose without seeing toxicity" specifies Felden, adding that "the participation and imagination of the team and our chemist colleagues was needed to devise the most active molecules possible."

See:

Irène Nicolas, Valérie Bordeau, Arnaud Bondon, Michèle Baudy-Floc’h, Brice Felden. Novel antibiotics effective against gram-positive and -negative multi-resistant bacteria with limited resistance. PLOS Biology, 2019; 17 (7): e3000337 DOI: 10.1371/journal.pbio.3000337

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

Protection mechanism in bacteria

Gram negative bacteria can cause diseases such as pneumonia, cholera, typhoid fever and E. coli infections, as well as many hospital acquired infections. They are increasingly resistant to antibiotics -- and this is partly because of the way they are built.

Gram negative bacteria are surrounded by a double membrane that forms a highly effective protective barrier and makes the cell far more resilient to antibiotics. The outer of these two membranes is composed of two types of molecule, phospholipid and lipopolysaccharide (LPS) in a unique asymmetric architecture, with LPS on the outside of the membrane and phospholipid on the inside. It is this architecture that makes gram-negative bacteria particularly resistant to antibiotics.

Understanding how these bacteria make this outer membrane could lead to the identification of new ways to combat bacterial infections, as this membrane is essential for bacterial survival.

Scientists at the University of Birmingham have recently made a step forward in understanding this process by identifying the first mechanism involved in the movement of phospholipid molecules towards this membrane.

Using biophysical techniques including x-ray crystallography and nuclear magnetic resonance, the Birmingham team were able to monitor the movement of phospholipids from the inner membrane towards the outer membrane directly through a series of proteins that form a pathway known as the Mla pathway. This pathway has previously been shown to be involved in disease but its exact function was not known. These results provide the first evidence of a protein machinery involved in these transport processes and opens up the possibility of targeting it for antibiotic development.

READ MORE: Artificial intelligence used to identify bacteria accurately

See:

Gareth W. Hughes, Stephen C. L. Hall, Claire S. Laxton, Pooja Sridhar, Amirul H. Mahadi, Caitlin Hatton, Thomas J. Piggot, Peter J. Wotherspoon, Aneika C. Leney, Douglas G. Ward, Mohammed Jamshad, Vaclav Spana, Ian T. Cadby, Christopher Harding, Georgia L. Isom, Jack A. Bryant, Rebecca J. Parr, Yasin Yakub, Mark Jeeves, Damon Huber, Ian R. Henderson, Luke A. Clifton, Andrew L. Lovering, Timothy J. Knowles. Evidence for phospholipid export from the bacterial inner membrane by the Mla ABC transport system. Nature Microbiology, 2019; DOI: 10.1038/s41564-019-0481-y

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

'Curvy bacteria' weigh the benefits of different shapes

Research by scientists into why some bacteria have different shapes has found that a curved shape can make it easier to find food. Computer simulations were used to compare the swimming of differently shaped bacteria. Results showed that a curved shape can be beneficial for efficient swimming and for finding food through the use of chemical trails (known as chemotaxis) - but at the expense of higher cell construction costs.

Life Sciences researchers at the University of Lincoln conducted computer simulations to compare the swimming of differently shaped bacteria. Results showed that a curved shape can be beneficial for efficient swimming and for finding food through the use of chemical trails (known as chemotaxis) -- but at the expense of higher cell construction costs.

This indicates that some bacteria species may balance the cost and benefits of their shape, depending on their environment and activity levels.

Before now it has not been understood what determines the different shapes of bacteria. While the shape of large creatures is driven by the effects of gravity and streamlining, for microscopic organisms these do not have such an impact.

Prof. Stuart Humphries, Professor of Evolutionary Biophysics at the University of Lincoln, said: "This work opens the door to asking a number of questions, for instance whether disease-causing bacteria have different shapes, or if different cell shapes improve the abilities of microbes we harness for industrial purposes."

READ MORE: Cilia: 'The bouncer' of bacteria

Prof. David Smith, Professor of Applied Mathematics at the University of Birmingham said: "This research shows how state of the art maths and supercomputing simulation, used alongside extensive survey of a wealth of microscopy data, enables us to explore and explain aspects of the immense diversity of the living world which have hitherto been impossible."

See:

Rudi Schuech, Tatjana Hoehfurtner, David J. Smith, Stuart Humphries. Motile curved bacteria are Pareto-optimal. Proceedings of the National Academy of Sciences, 2019; 201818997 DOI: 10.1073/pnas.1818997116

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

Microbiome-directed therapeutic foods tackle childhood malnutrition

The results of two new reports, linking the growth of infants and children to healthy development of gut microbiomes, were published in Science on July 12th. Researchers utilized microbiome-directed complementary foods in an approach that focuses on selectively boosting key growth-promoting gut microbes using ingredients present in affordable, culturally acceptable foods.

See: https://www.scienceboard.net/index.aspx?sec=sup&sub=msyn&pag=dis&ItemID=194



Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

Good Distribution Practice (GDP) Symposium

MHRA have released a summary of the recent Good Distribution Practice (GDP) Symposium. The focus of the 2018 GDP symposium was maintaining compliance in a changing world.

One of the interesting things to note is with the top five deficiencies were reported as follows:

• Chapter 1 Quality Management – 38% of inspections
• Chapter 9 Transport – 25% of inspections
• Chapter 5 Qualification of Customers – 20% of inspections
• Chapter 6 Returned Medicinal Products – 18% of inspections
• Chapter 2 Responsible Person – 15% of inspections

From this, organizations should be putting together personal learning action plans, namely:

• identification of role improvement opportunities
• evaluation of learning needs
• increasing knowledge of licence activities
• undertaking new learning opportunities
• maintaining learning records

Full details can be found here:  https://mhrainspectorate.blog.gov.uk/2019/06/11/the-2018-good-distribution-practice-gdp-symposium/

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

Pharmaceutical microbiology: current and future challenges

On 15th October 2018 Tim Sandle delivered the key note address to the PDA Microbiology Europe conference. Tim Sandle has written an article which takes the form of an edited transcript of the presentation.

Whilst there is a continuing need for monitoring of the environment and conducting standardized laboratory tests, pharmaceutical microbiology has moved on to embrace:

• Microbiological audits;
• Rapid microbiological methods;
• Conducting risk assessments, both proactive in terms of minimizing contamination and reactive, in terms of addressing microbial data deviations;
• Ensuring that processes meet ‘quality by design’ principles;
• And getting the microbiologist away from the bench and into the plant.

These themes are captured in the auricle, for which the reference is:

Sandle, T. (2019) Pharmaceutical microbiology: current and future challenges, Pharmig News, Issue 75, pp12-15

For details, please contact Tim Sandle

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

Some Useful Tips to Open PCD Franchise Company

India carefully monitors their healthcare services, so opening a pharma company in India can be a good business idea. In this guide, we will explain how to open a monopoly pharma franchise company in India. Find out the requirements, read the tips for choosing a place to place a new business and consult the list of the best franchises currently operating in India.

A guest post by Satvir Singh

Open a PCD pharma franchise in India:

In addition to selling over-the-counter drugs, you can sell health and beauty products, such as cosmetics, baby products, and food for specific needs, such as celiac disease, diabetics or low-calorie products, and most veterinary drugs.

Do I need to have a pharmaceutical education to open a pharmacy in India? This may surprise you, but the answer is no. Having 3-5 years of working experience in the pharma sector is enough. But if you do not have an education, you will definitely need to hire a qualified pharmacist to sell medicines. This means that the owner of the company can be anyone, but in this case he will have to consider the need for constant cooperation with one or more certified pharmacists.

The presence of a pharmacist is not the only requirement required to open a pharmacy.

Requirements for opening a pharmacy in India

As we explained several paragraphs above, even if you do not need to have a pharmacist diploma to open a pharmacy, there are other requirements and procedures that must be followed. For example, you need to get a ISO, GMP and WHO certificates if you decide to sell pharma product and supplements, even if they are packaged.

As for opening a pharmacy, you also need:

• Request registration of a pharmacy at the Ministry of Health & FSSAI
• Make a message about starting a business in the municipality

Register with the Chamber of Commerce.

The second and third points are not different from the procedure for opening any other business. Registration of activities in the Ministry of Health is the only way to organize the subsequent delivery of drugs to the warehouse of the outlet. In fact, after checking the submitted documentation, the pharmacy will be assigned the code necessary for the purchase of medicines. In addition, after obtaining permission from the Ministry of Health, the company will be registered in the database of authorized pharmacies and pharmacies and, therefore, can sell its products even through the Internet.

How to choose a place for the pharmacy: a few tips?

Some franchise requires certain functions from the premises in which the franchisee’s pharmacy will be opened. However, regardless of this, keep in mind that it is always recommended to open a company in areas with a large inflow of people, in any case, in urban centers, at least medium-sized.
Always make sure that there are no other suppliers in the immediate locality, and in any case carefully consider whether a potential clientele, based on the population of the area, can be sufficient for a new point of sale.

As for the size of the place, an average / large area is always recommended. Keep in mind that you definitely need a medium size store room. You can take assistance from the top PCD pharma franchise company listed on PharmafranchiseeIndia . Our experts are always there to help you out and clear your doubts and answer your questions 24/7.

Careless disposal of medicines increases antimicrobial resistance

There are a number of ways by which antimicrobial resistance can spread, and one that is of growing concern is the disposal of medicines by consumers down sinks and toilets. A new technique can help to assess the extent of the spread.

Antimicrobial resistance is an established global health problem which is characterized by the ability of microorganisms to counter the effects of medicines. The threat posed by this to human populations is such that the tackling of the problem is classed as one of the Sustainable Development Goals of the World Health Organization.

One factor that is not helping with the rise of antimicrobial resistance is the way that medicines are disposed of. Various reports indicate the significant role of the environment in the emergence and spread of resistance to antimicrobials. Antimicrobials, like antibiotics, enter the environment through too many people choosing to dispose of medicines themselves at home (such as by flushing the unwanted medications down a sink of via the toilet) rather than returning the unused medication to the originating pharmacy for safe disposal.

As to how widespread the presence of antimicrobial organisms are in the sewage system and the extent that this related to human activity has been difficult to discern, particularly any variations with the patterns of resistance worldwide. A new method, based on a mix of genetics and statistical analysis aims to address this knowledge gap.

The novel method, which comes from the Technical University of Denmark, involves assessing genetic materials recovered from untreated sewerage. The technique demonstrates how this analysis can assist scientists which identifying antimicrobial resistance patterns in areas where there are human populations worldwide. The focus of the research, and where data was collected for the analysis, was in regions of Africa, Asia and South America. These data, where it was found there are high levels of antimicrobials, were contrasted with North America and Western Europe, where levels were found to be relatively lower.

These patterns were visualized through an examination of the genetic materials extracted from untreated sewerage in 74 cities, from samples drawn across 60 countries. The follow-up step was to analyze the data using statistical methods. From this, the researchers were able to estimate patterns of resistant bacteria across different global regions.

According a summary by Science Development: "The countries standing out as having the most divergent distribution of antimicrobial resistance genes were Brazil, India and Vietnam, suggesting that these countries could be hot spots for emergence of novel antimicrobial resistance mechanisms."

The concern for less developed regions is that antimicrobial resistance gene abundance strongly correlates with socio-economic, health and environmental factors, meaning that countries with fewer resources and poorer populations will face greater challenges in addressing the concern.

The new method to assess resistance patterns has been reported to the journal Nature Communications, where the paper is titled "Global monitoring of antimicrobial resistance based on metagenomics analyses of urban sewage."

Written by Dr. Tim Sandle, Pharmaceutical Microbiology

Is anxiety linked to our gut microbiome?

Microbiome research has advanced considerably since the first results from the U.S. National Institutes of Health led Human Microbiome Project were released. One area of interest is the connection between our microorganisms and anxiety symptoms. At first glance, the connection between the array of different microorganisms that are found within the human gut and feelings such as anxiety is not an obvious one. However, there is a growing level of evidence that variations within microbial communities are influential upon metabolic processes.

Human microbiome

The human microbiome refers to the totality of microorganisms and their genetic interactions within a given niche. Our understanding of the microbiome has advanced following a study of 300 men and women, who volunteered to take part in an international study. The advancement in understanding relating to developments with the methods used to characterize the microorganisms (including metagenomics) and the in-depth nature of the study, relating to the sampling of many body parts over a prolonged period of time, and drawing upon of the subjects from different geographical locales.

FDA microbiologist prepares DNA samples for gel electrophoresis analysis

FDA / File

With the specific effects in relation to the human gut, then the understanding by scientists of the gut-brain axis has increased during the past ten years, suggesting a bidirectional nature between the gut and brain microbiome interactions. This includes a connection relating to the pathophysiology and pathogenesis of irritable bowel syndrome (IBS), as an example.

In another research field, there is growing evidence of psychiatric and neurologic disorders like autism spectrum disorders, affective disorders, Parkinson's disease, and multiple sclerosis, being connected to the human gut microbiome.

The reason for this is that, with most people, the gut microbiota assist with the healthy functioning of the immune system. Furthermore, organisms assist with the metabolism by contributing inflammatory mediators, vitamins, and nutrients. Moreover, microbiologists have demonstrated that the intestinal microbiota can modulate communication between the intestinal tract and human brain via the nervous, immune, and endocrine systems.

It may be possible to treat superbugs with a predatory bacteria.

University of Nottingham

However, when the intestinal microbial balance is altered, then changes occur and these can be manifest in terms of physical, and potentially mental, symptoms. One area being investigated in relation to a mental system is anxiety.

Anxiety

Anxiety is an emotion characterized by an inner turmoil. It is often accompanied by nervous behaviour, somatic complaints, and rumination. The condition includes subjectively unpleasant feelings of dread over anticipated events. When experienced regularly the individual may suffer from an anxiety disorder. The global incidence of anxiety disorder is estimated to be between 3-25 percent. Typical treatment for anxiety is usually psychopharmacological therapies and psychotherapy.

New research

With the new research, scientists have attempted to see if anxiety symptoms can be improved by regulation of intestinal microorganisms. By assessing some 3,334 published articles the researchers focus on 21 major studies. Across these studies,1,503 participants included "patients with IBS (10 studies), healthy controls (six studies) and other patients with chronic diseases such as chronic fatigue syndrome (CFS), rheumatoid arthritis (RA), obesity, fibromyalgia, and type 2 diabetes mellitus."

Of the 21 studies, 14 had chosen probiotics as interventions to regulate intestinal microbiota (IRIFs), and seven chose non-probiotic ways, such as adjusting daily diets. Those studies that utilized "interventions regulating intestinal flora" consisting of probiotics with Lactobacillus alone or a mixture of Lactobacillus, Streptococcus, and Bifidobacterium, showed some positive results. Overall, 11 of the 21 studies suggested a positive effect on anxiety symptoms by regulating intestinal microbiota, meaning that more than half (52 percent) of the studies showed this approach to be effective.

Some of the bacteria found by scientists in 3.5-billion-year-old fossils are now extinct, while others are similar to contemporary microbes

MARTIN BERNETTI, AFP/File

To draw these conclusions the review was subjected to meta-analysis, considering the research design, subjects, interventions, and anxiety assessment scales. This drew out the connected between anxiety and disturbances to the gut microbiome and indicated that it may be possible to regulate the intestinal microbiota through the use of probiotics, although further research will be required.

The researchers conclude: "We find that more than half of the studies included showed it was positive to treat anxiety symptoms by regulation of intestinal microbiota.

"There are two kinds of interventions (probiotic and non-probiotic interventions) to regulate intestinal microbiota, and it should be highlighted that the non-probiotic interventions were more effective than the probiotic interventions. More studies are needed to clarify this conclusion since we still cannot run meta-analysis so far."

Research paper

The new research has been published in the British Medical Journal, with the research paper titled “Effects of regulating intestinal microbiota on anxiety symptoms: A systematic review.”

Written by Dr. Tim Sandle, Pharmaceutical Microbiology

ICH M10 on bioanalytical method validation

The draft ICH guidance is currently out for review. This proposed new multidisciplinary guideline will address the validation of bioanalytical assays. This guideline will provide recommendations on how to validate a bioanalytical assay for drug quantification and how to apply validation during study sample analysis. However, this guideline does not provide recommendations which analyte should be analysed. This is covered in other ICH and regional regulatory documents.

The draft looks at:

Concentration measurements of chemical and biological drug(s) and their metabolite(s) in biological matrices are used as part of regulatory decisions regarding the safety and efficacy of drug products. It is therefore critical that the bioanalytical methods used are well characterised, appropriately validated and documented in order to ensure reliable data to support regulatory decisions. The objective of the validation of a bioanalytical assay is to demonstrate that it is suitable for its intended purpose. This guideline is intended to provide recommendations for the validation of bioanalytical assays for chemical and biological drug quantification and their application in the analysis of study samples.

See: https://www.ema.europa.eu/en/ich-m10-bioanalytical-method-validation

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

EMA Offers Q&A on Using OOS Batches of Authorized ATMPs

The European Medicines Agency’s (EMA) Committee for Advanced Therapies (CAT), together with the GMDP Inspectors Working Group and the Blood Products Working Party, have released a questions and answers (Q&A) document on how companies should go about using OOS batches of authorized cell or tissue-based advanced therapy medicinal products (ATMPs).

See: https://www.ema.europa.eu/en/documents/other/questions-answers-use-out-specification-batches-authorised-cell/tissue-based-advanced-therapy-medicinal-products_en.pdf

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

Biotechnology: From Idea to Market

A new and important book has been released "Biotechnology: From Idea to Market", edited by Fred Mermelstein, Carl Novina, and Richard Prince.

Biotechnology: From Idea to Market, is an invaluable guide and reference for anyone involved in the development of a product, from idea generation through commercialization.

The goal of this book is to provide this comprehensive overview for students and professionals alike in how to think about and to navigate the necessary development process for healthcare product candidates, including biologics, new chemical entities, and other related products that address medical need. This instructional text enables anyone at any level or in any sector of the industry to easily achieve a basic knowledge of the critical steps (or the questions to ask) to properly evaluate an idea or technology, develop a viable product candidate, and ultimately advance it to the marketplace.

Expertly conceived and crafted by co-editors Fred Mermelstein, Richard Prince, and Carl Novina, with a foreword by Nobel Laureate Philip Sharp, this book features 22 chapters written by renowned subject matter experts in their respective fields. Collectively, these chapters illuminate and unify the healthcare products innovation process, spanning from academia to industry, from research to commercialization.

See below for further details and visit the PDA Bookstore.

Biotechnology: From Idea to... posted by Tim Sandle 

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

Cost of Tick-Borne Disease Misdiagnosis

Nearly 36 percent of patients with a tick-borne disease spent more than $10,000 on tests, treatments, appointments, and other costs associated with their disease, a new IGeneX survey found.

The survey analyzed the cases of 198 patients from 2018 and 2019 who were tested by IGeneX, a leading testing lab in California. Researchers sought to determine how long it took for patients to obtain a proper diagnosis, how many doctors they had visited, and how much financial impact they had ultimately incurred.

According to the survey:

• 45% of patients needed more than three years to obtain the proper diagnosis
• 65% of patients were forced to quit a job or cut back on their hours due to their symptoms
• 24% of patients saw more than ten doctors before receiving a proper diagnosis
• 86% of patients suffer from long-term side effects from not having been diagnosed sooner

Most experts agree that the best patient outcomes are achieved when Lyme disease and other tick-borne diseases are diagnosed and treated as early as possible. “When a tick-borne illness is misdiagnosed, the disease-causing infection has more time to spread, which can lead to more severe or chronic health issues,” says Dr. Jyotsna Shah, President of IGeneX. “That can lead to months and even years of escalating costs for patients and their families due to ongoing doctor visits, diagnostic tests, ineffective medications, and other medical expenses.”

Tick-borne diseases are on the rise and prevention should be on everyone’s mind, particularly during the spring, summer, and early fall when ticks are most active. Prevention and early detection are part of the safety protocol extended by the Centers for Disease Control and Prevention.

Researchers hope that the survey will help educate the public on the risks associated with delaying testing or relying on old testing techniques. "In our view, many patients are missed because much of the testing recommended by general practitioners is based on technology from 25 years ago," says Dr. Shah. "Science has progressed, and we can now give patients a much more accurate diagnosis than was available years ago."

For an infographic of key findings from the survey, please go here. For a complete view of the survey results, please go here. For more information on tick-borne diseases and how to get tested, please visitwww.igenex.com or www.cdc.gov.

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

Malaria - High-Tech Bednet Use Monitoring Tool

Study Finds High-Tech Bednet Use Monitoring Tool Produces Detailed Data on Daily Usage, Offering a New Tool to Study Declining Efficacy In Malaria Prevention

A new technology sewn into the lining of mosquito-fighting bednets provides precise, detailed data on household bednet use, insights that could help answer why the effectiveness of this mainstay of malaria control appears to be waning, according to a new study from researchers at the University of California, San Francisco appearing today in the American Journal of Tropical Medicine and Hygiene.

A global effort to distribute long-lasting insecticide-treated bednets has been credited as a key force driving a dramatic reduction in malaria infections and deaths. But the researchers cited recent studies indicating that bednets may no longer be as effective as previously thought, though exactly why is not clear.

Researchers developed and tested a technology called SmartNet that uses a battery-powered microcontroller connected to a conductive fabric in the bednets to record when they are in use or folded up. Testing in 10 households in rural Uganda over 418 days found average use was relatively high—85 to 90 percent between 9 p.m. and 6 a.m., when malaria-carrying mosquitoes are out in force. But usage was also highly variable, with some households using them only half as much as others and in some instances failing to use them at all, increasing risks of malaria.

The researchers hope this kind of automated monitoring can provide an inexpensive, unobtrusive way of tracking household patterns of bednet use. They note that while the search to understand the decline in bednet efficacy has focused on mosquito biting behavior, insecticide resistance and bednet durability, the role of human behavior “is a potentially important and under-researched component” of the problem.

>> Abstract


Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

Best practices for microbial control

Sterile pharmaceutical products need to be manufactured to the highest possible standards and the technology, processes and regulatory expectations continue to shift. Understanding these changes, in light of the latest regulatory thinking, was theme of a two-day event in the Adriatic region.

In relation to this area of microbiological best practices, Tim Sandle has written a new article. The reference is:

Sandle, T. (2019) Best practices for microbiological control, Pharmig News, Issue 75, pp6-7

For details, contact Tim Sandle

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology