Wednesday 31 July 2019

Big Investments for Human Microbiome Research

The Human Microbiome Project (HMP) was a U.S. National Institutes of Health (NIH) initiative that set the goal of identifying and characterizing the microorganisms which are found in association with both healthy and diseased humans, based on a budget of $115 million. The aim was to inform about human health or disease. Drawing on the wealth of data provided by the HMP, many companies are investing in microbiome based research.

Tim Sandle has written an article for BioPhrma Trends. Here is an extract:

"Capitalizing on new understanding of how imbalances in this ecosystem contribute to disease, a handful of startups aim to give physicians better weapons to fight conditions such as cancer, autoimmune disorders and infection. Examples include Vedanta Biosciences Inc, a start-up that has teamed up with New York University Langone Medical Center to study how bacteria can be used in the battle against tumors. Drug delivery is a related area with start-up Blue Turtle Bio utilizing bacteria from the gut microbiome as a drug delivery platform for supplemental enzymes intended to treat enzyme-deficient disease states."

To access, see:

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

Monday 29 July 2019

Contamination control hot topics

There are a number of challenges facing pharmaceutical and biopharmaceutical companies in relation to controlling contamination in their facilities. To address some of these issues American Pharmaceutical Review recently hosted a contamination control roundtable.

Taking part were: Tony Cundell, Paula Peacos, Tim Sandle and Jeanne Moldenhauer.

Here is an extract from Tim Sandle:

“The problems will vary between different facilities, and these will center on the different sources of contamination in relation to people, air, water, transfer of items, equipment cleanliness, and bioburden of starting materials. The most difficult challenges are invariably around people: how personnel behave in cleanrooms, how they are gowned, and whether they follow the correct procedures. Although the regulations around personnel have largely remained unchanged, its noticeable that the number of warning letters and other regulatory citations have increased. The reason for this must rest with training, knowledge and with time (in terms of allowing operators sufficient time to carry out their duties and to clean and disinfect effectively).

“Keeping track of data is also a challenge. With large facilities in particular, assessing microbial and particulate trends remains important so that appropriate actions can be taken promptly. Furthermore, it is important to understand when the process is leaning out of control, to enable personnel to be alerted to a potential change in the process.”

The reference is:

Cundell, T., Peacos, P., Sandle, T. and Moldenhauer, J. (2019) Contamination Control Roundtable, American Pharmaceutical Review, 22 (3): 44-47

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

Saturday 27 July 2019

EDQM inspections and trends of GMP deficiencies: Overview 2006 to 2018

A review of data from API inspections conducted by the EDQM between 2006 and 2018 is now available (PA/PH/CEP(18) 56 April 2019).

This document summarises the trends of deficiencies observed in EDQM inspections with reference to EU GMP and to the corresponding CEP dossiers.

This document is a review of data from API inspections conducted by the EDQM between 2006 and 2018. It covers: - the location of the inspections; - whether they were initial or re-inspections; - their outcome; - the distribution of the observed deficiencies to EU Good Manufacturing Practice (GMP) Part II area and criticality; - the frequency of the findings; - issues of data integrity.

For details, see:

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

Monday 15 July 2019

An interview with Dr. Tim Sandle

Dr Tim Sandle is currently Head of Microbiology and Sterility Assurance at Bio Products Laboratory Limited. Here he talks to the Microbiology Society about his current role, his area of research and the importance of antimicrobial resistance (AMR) as a health issue. He also explains why he joined the Microbiology Society and offers advice for anyone thinking about a career change.

You are currently Head of Microbiology and Sterility Assurance: tell us more about your role with Bio Products Laboratory Limited.

I am responsible for heading up four departments. One is associated with supporting the manufacturing areas in terms of assessing cleanrooms for levels of microorganisms in the air and on surfaces for assessing product bioburden, microbial levels in water, screening samples for bacterial endotoxin and verifying that the finished product is sterile. The second area is associated with the development of novel microbial methods, the qualification of equipment, and dealing with regulatory submissions. The third area is to do with risk assessments, carried out in order to lower microbial contamination risks in process areas and to investigate when high microbial levels are recovered. The fourth area is linked to proactive practices to improve hygiene and to support new technologies. My role is to ensure these different entities connect together and to develop appropriate policies and standards in order to enhance sterility assurance.

Why did you choose to become a microbiologist?

I was always interested in biology: as a child, I was encouraged by my grandfather to take an interest in the natural world. I started off with an interest in biological sciences in general and was encouraged by a teacher to consider the importance of microbiology in health and disease.

Do you have any advice for anyone thinking about a career change and making a brave move from academia to industry?
The key attraction with industry is the ability to research and develop life-saving medicines and see these come to fruition. However, it is a different working experience and there are different types of pressures (these days both academia and industry are subject to increasing cost and time demands). Certainly, in industry there is a need to produce and release on schedule, otherwise this creates financial complexities. However, the work is very varied and there remains opportunities to engage in research and to produce papers. I’ve certainly managed to continue to contribute to peer-reviewed papers and book chapters. There also remains the opportunity to present at conferences.

Tell us about your biggest professional achievement(s) so far.

Some of the recent research I’ve been undertaking has concerned a partly overlooked issue of whether organisms that are resistant to antimicrobials have enhanced resistance to biocides. Although there is no direct evidence that organisms can acquire resistance to disinfectants, organisms that are resistant to antimicrobials may be harder to kill with the disinfectants commonly used in the pharmaceutical or healthcare setting. There is some evidence of this with some organisms, which calls for a renewed focus on aspects of disinfectant efficacy, like the minimum inhibitory concentration.

Tell us about your area of research?

The research is mostly applied. Over the past few years I’ve been working with microbiologists in Saudi Arabia, principally Dr Vijayakumar Rajendran, to determine the frequency of biocide resistant genes (e.g. qacA, qacE and cepA) in multidrug resistant bacteria, such as Klebsiella pneumoniae, Pseudomonas aeruginosa and Acinetobacter baumannii, and to correlate the presence or absence of resistant genes with biocides susceptibility. We’ve written several papers looking at different organisms and different biocides, assessing whether organisms that are antimicrobial resistant are also more resistant to common disinfectants. The research may have an impact on how pharmaceuticals and healthcare works, such as the need to reassess minimum inhibitory concentrations.

What have you done to try to maximise the impact of your research?

The research is ongoing and the full implications have yet to be realised; however, the research is showing a new dimension to the antimicrobial issue. The main thing in terms of impact is kicking-off discussion about overlooked areas in relation to AMR, which should help to encourage other researchers to consider different perspectives. Outside of this, I publicise where I can the importance of taking steps to reduce AMR, especially when different international campaigns are taking place. Social media provides a great outlet for this.

How important is AMR as a health issue?

It is an issue of great importance. Humans face the very real risk of a future without antibiotics. The implications of this are that life expectancy could fall due to people dying from diseases that are readily treatable today. In the last two decades, the rate at which bacteria are becoming resistant to current antibiotic treatments has substantially increased. For example, this trend is threatening the ability of medical staff to carry out routine operations or transplants in the future.

In your opinion, which areas of research are likely to have greatest impact on tackling AMR in the future?

Scientists have a role in addressing AMR even if they are not directly involved with AMR research or practices. This is by helping to promote best practices, such as avoiding the mis-prescribing of antibiotics to patients or though seeking better practices and alternatives to antibiotics in terms of rearing animals. One key research area that will have the greatest impact is in the search for new antimicrobials. There are some interesting ones in development, such as Dalvance, an intravenous drug that can treat skin and soft tissue infections; Oritavancin, a lipoglycopeptide with bactericidal activity against Gram-positive bacteria; and Teixobactin, a peptide-like secondary metabolite found in some bacteria that kills some Gram-positive bacteria and which has received the most media attention. The search for new antimicrobials, however, needs to continue, and the spectrum of searching needs to extend to areas of low human contact, such as deep in caves or parts of the oceans.

Do you have any advice for early career scientists who’d like to work in AMR?

First, research into AMR is a long process and there are many routes that do not lead to anything tangible. Patience is important. Second, potential candidate drugs to address AMR can come from the most unlikely of places, so keeping an open mind is also important.

The Microbiology Society is often seen as a Society for academics. What would you say to disperse this myth? What are the main benefits of being a member?

The Microbiology Society provides topical material for microbiologists in all sorts of occupations, not just academia. In recent years there has been a variety of different topics that connect what is being researched in universities to what needs to be developed by industry in order to meet healthcare demands – the hunt for new antimicrobials being a prime example. The Microbiology Society is so varied, and this richness leads to a range of different subject matter that enhances knowledge across both academia and industry. The sharing of ideas across these two sectors is to the benefit of all professional microbiologists. It provides an important arena for networking and sharing ideas across a range of different microbiological disciplines. It also plays a vital role in promoting the interaction between microbiologists and the general public, helping to educate and to engage.

And finally, why does microbiology matter?

Microbiology matters because it impacts across every aspect of society, from food production to global warming (such as toxic algal blooms); to the development of new medicines through biotechnology; for protecting the manufacture of medicines from contamination; and, of course, in protecting people from disease and with fighting diseases. Through being involved with any of these fields, you can make a difference.

Are you a member and interested in sharing stories about your research journey? Email March 2019


Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

Monday 1 July 2019

Sandle's Pharmaceutical Microbiology Dictionary

Pharmaceutical Microbiology, an applied branch of Microbiology, focused on study of micro-organisms associated with the manufacture of pharmaceuticals, primarily in minimizing the numbers in a process environment; ensuring that the finished product is sterile and excluding those specific strains that are regarded as objectionable from starting materials and water. The discipline is also associated with drug development, including the application of biotechnology. This dictionary provides definitions and descriptions of the leading terms association with pharmaceutical microbiology and related fields. The dictionary is designed to assist students and those who do not work directly in the field to understand the terminology; and as an aide-memoire for more experienced practitioners.

The book is available as an e-book or as a paperback via Amazon.

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

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