Emergence of new antibiotics

The growing menace of antibiotic resistance is, arguably, the single biggest threat faced by the world's population. However, in 2014 a change in direction has occurred with the announcement of two new antibiotics. 

The first of the new antibiotics is called Dalvance. This is an intravenous drug that can treat skin and soft tissue infections.

The second drug is called Oritavancin. Oritavancin is a lipoglycopeptide with bactericidal activity against Gram-positive bacteria.

Both of these new antibiotics are discussed in a new paper by Tim Sandle. 

The reference is:

Sandle, T. (2014) Emergence of New Antibiotics, J J Microbiol Pathol., 1(1): 001

If you are interested in a copy, please contact Tim Sandle

Posted by Tim Sandle

FDA: Bacterial Detection Testing by Blood Collection

FDA has issued a new guidance document in relation to blood. The document is titled “Bacterial Detection Testing by Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion.”

In summary, the scope is:

“This draft guidance, when finalized, will represent the Food and Drug Administration’s (FDA’s or Agency’s) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance.”

The guidance is currently presented as a draft and is out for comments.

For details see: FDA

Posted by Tim Sandle

Rapid Micro Biosystems Announces Availability of Bi-Directional LIMS Integration

Rapid Micro Biosystems, a leading provider of automated, non-destructive, rapid microbial detection, today announced the general availability of two-way integration to laboratory information management systems (LIMS) through its industry leading Growth Direct™ System. The new capability allows quality control microbiology labs to save time and reduce errors associated with entry of final test results of environmental monitoring, bioburden and sterility tests.  

The bi-directional LIMS integration uses widely supported comma-separated (CSV) files to communicate, allowing integration with most LIMS systems.  Due to the flexibility provided by the communication method, integration can be aligned to the specific needs of the quality control microbiology lab both initially and in the future. 

The integration supports the use of LIMS or Growth Direct System created barcodes that are applied to Growth Direct Cassettes.  After sampling, the cassettes are loaded into the Growth Direct System, which performs the incubation, detection and enumeration of colonies.  Final results are automatically uploaded to the LIMS system.   This eliminates the need for microbiologists to manually count plates and key the colony forming unit (CFU) values into the LIMS system, reducing the chance of a keying error. 

“Our two-way LIMS capabilities will not only save time, but will help reduce errors in the QC lab,” said Julie Sperry, Rapid Micro Biosystems’ Chief Commercial Officer. “The new functionality will help labs move closer to becoming paperless.”

Rapid Micro Biosystems will be discussing two-way LIMS integration and other rapid microbiology method capabilities at this week’s European Compliance Academy’s Rapid Microbiology Methods Conference in Heidelberg, Germany.

Posted by Tim Sandle

Ebola: environmental cleaning guidance for potential contamination

The U.K. government has issued a report titled “Ebola: environmental cleaning guidance for potential contamination.”

People infected with Ebola are infectious only when they have developed symptoms. These include fever, headache, diarrhoea and vomiting. Once symptomatic, all body fluids such as blood, urine, faeces, vomitus, saliva and semen are considered infectious, with blood, faeces and vomit being the most infectious.

This guidance provides information on:

• precautions to be taken by people carrying out cleaning procedures associated with suspected and confirmed cases of Ebola,
• actions to take after the suspected case of Ebola has been assessed.

For further details, see Ebola

Posted by Tim Sandle

New method of bacterial cell ingress described

New research revealed how certain harmful bacteria drill into our cells to kill themHere bacterial ‘nanodrills’ assemble themselves on the outer surfaces of cells and punch holes in the cells’ outer membranes. The findings give a detailed view of how these bacterial toxins drill holes in cell membranes.

The discovery supports the development of new drugs that can target bacterial nanodrills and help treat the diseases in which they are implicated. These include pneumonia, meningitis and septicaemia.

For further details see:

Carl Leung, Natalya V Dudkina, Natalya Lukoyanova, Adrian W Hodel, Irene Farabella, Arun P Pandurangan, Nasrin Jahan, Mafalda Pires Damaso, Dino Osmanović, Cyril F Reboul, Michelle A Dunstone, Peter W Andrew, Rana Lonnen, Maya Topf, Helen R Saibil, Bart W Hoogenboom. Stepwise visualization of membrane pore formation by suilysin, a bacterial cholesterol-dependent cytolysin. eLife, 2014; 3 DOI: 10.7554/eLife.04247

Posted by Tim Sandle

Gut Microbes trigger malaria-fighting antibodies

A carbohydrate antigen found on cells of E. coli and other species prompts a potent immune response against malaria-causing parasites in mice.

Up to 5 percent of the antibodies circulating in the blood of healthy adults are directed against the carbohydrate antigen Galα1-3Galb1-4GlcNAc-R, also known as α-gal. This molecule decorates the surfaces of many human-associated bacteria, as well as protozoan pathogens, and antibodies against it are cytotoxic to these microbes in vitro.

Now, scientists at the Instituto Gulbenkian de Ciência in Portugal and their colleagues have established an in vivo role for anti-α-gal antibodies in protecting mice against malaria infection.

A team led by Bahtiyar Yilmaz and Miguel Soares has now shown that E. coli bacteria colonizing the guts of mice elicit the production of anti-α-gal antibodies. High levels of anti-α-gal antibodies are also linked to malaria resistance in humans, the researchers noted in Cell ("Gut Microbiota Elicits a Protective Immune Response against Malaria Transmission.")

For further details, see The Scientist.

Posted by Tim Sandle

Good Distribution Practice

ECA and PQG will publish their next chapter of the interpretation of the EU GDP Guide The ECA Foundation Working Group on GDP and the Pharmaceutical Quality Group (PQG) have published an additional chapter of the interpretation of the EU Good Distribution Practice GDP Guide – Chapter 5 operations.. The Joint Task Force has already published its interpretations of Chapters 1,2,7 &9 (Quality management, personnel, outsourced activities & transportation).

For details see: ECA

Posted by Tim Sandle

Pharmacopeial changes in relation to pyrogens and endotoxin

The European Pharmacopeia (Ph. Eur.) is proposing a series of changes in relation to the testing of pyrogens and for bacterial endotoxin. The changes represent the most significant changes to the approach since the Ph. Eur harmonised the bacterial endotoxin test (BET) chapter with the United States and nJapanese pharmacopeia during the early 2000s.

A new article from Tim Sandle for the GMP Review outlines the key changes.

For a copy of the article, please contact Tim Sandle

The reference is:

Sandle, T. (2014) Pharmacopeial changes in relation to pyrogens and endotoxin, GMP Review, 13 (3): 10- 12

Posted by Tim Sandle

Sterilisation, Sanitisation and Disinfection course

New PHSS course: Sterilisation, Sanitisation and Disinfection

Requirements of effective contamination control and the appropriate steps to manage deviations.

• DATE: Thursday 18th February 2015
• VENUE: Four Pillars Hotel, Abingdon, U.K.
• PRICE: £350 Members, £450 Non Members

Speakers:

Jenni Tranter, Synergy Health
Alan Heavey, Sterilisation Solutions Ltd
Tim Sandle, BPL
Alison Livsey, Contec

For details see: PHSS course

Posted by Tim Sandle

Cleaning and Disinfection Handbook

 Cleaning and Disinfection Handbook

Contamination control is of great importance to healthcare facilities and to pharmaceutical cleanrooms. With healthcare, the more immediate concern is with protecting the patient from infection (infection prevention practices aim to eliminate the risk of the transmission of pathogens between patients and between patients and the health care worker). With pharmaceuticals the concern is with avoiding contamination of the product being prepared so that the product is safe for use. Both healthcare facilities (from hospital wards to pharmacy units) and pharmaceutical facilities share a number of similarities, from the importance of hand sanitization to the control of cleanrooms.

The key interconnecting aspect is the use of cleaning agents (detergents) and disinfectants. Therefore designing an effective cleaning and disinfection program is a critical part of the contamination control approach. Whilst there are a myriad of different agents on the marketplace, not all are suitable for cleanrooms, hands or hospital wards. To add to this there is a sometimes bewildering choice of different chemicals with different modes of action, many of which are incompatible with one another. From this there is often ambiguity about how such agents should be used including questions of ‘how often should I use this?’, ‘how do I dilute it?’, ‘how long do I leave it for?’ coupled with confusion over cleaning methods and techniques. In relation to these issues it became clear that there was no book, of smaller size, which addressed these issues for those concerned with keeping hospitals and cleanrooms clean. In light of this, the idea for a book - “The Cleaning and Disinfection Handbook” - was born.

For a free excerpt from the book, click here.

For the press release, click here.

The book is available from Amazon worldwide:

Amazon.com                                                                               Amazon U.K.

Amazon Austria                                                                          Amazon Canada

Amazon China                                                                            Amazon France

Amazon Germany                                                                       Amazon Italy

Amazon Japan                                                                            Amazon Spain

Amazon India                                                                             Amazon worldwide

Here are some further details:

‘The CDC Handbook’, a new ‘Guide to Cleaning & Disinfecting Cleanrooms’ has just been published and is available as a paperback and an e-Book. Edited by Dr Tim Sandle, a pharmaceutical microbiologist, the CDC Handbook has contributions from expert practitioners actively involved in contamination control within clean areas and controlled environments. It has been written for those working in both the pharmaceutical and healthcare sectors, as well as providing valuable information for students and the general reader. The illustrated Handbook balances theoretical concepts with sound practical advice. It provides comprehensive detail about different types of disinfectants and their modes of action; explains the problems of microbial destruction and resistance; introduces cleaning techniques and the latest safety regulations and expounds upon the application of cleaning within healthcare and pharmaceutical environments, noting current national and international standards.  To help less experienced readers, the book contains a glossary of terminology.

The book’s editor and main contributor, Dr Sandle says: ‘The use of detergents and disinfectants is a critical part of the contamination control approach. There are a myriad of different agents, but not all are suitable for cleanrooms, hands or hospital wards. Also, there is a sometimes bewildering choice of different chemicals with different modes of action, many of which are incompatible with one another. There is often ambiguity about how such agents should be used including questions of 'how often should I use this?', 'how do I dilute it?', 'how long do I leave it on for?' coupled with confusion over cleaning methods and techniques. In relation to these issues it became clear that there was no handbook which addressed these issues for those concerned with keeping hospitals and cleanrooms clean. In light of this, the idea for this book - "The Cleaning and Disinfection Handbook" - was born.’

‘In putting this book together, some of the leading experts in the field of contamination control, working either in healthcare or the pharmaceutical industry, were approached. In agreeing to contribute to this book each person has written a high quality chapter and has helped to put together what is a unique book on cleaning and disinfection. The book is subtitled "a handbook" and this is the operative word that, as editor I would most like to see applied. This is not a book intended to sit on a shelf and gather dust, it is a book intended to be read and discussed by those with the very important task of keeping cleanrooms, hospitals and the hands of staff, clean. If "The CDC Handbook" becomes an established part of the educational resources available to the workforce who aim to keep critical areas clean, then the aims and intentions which shaped this book will have been a success.’

Posted by Tim Sandle

Registration of Human Drug Compounding Outsourcing Facilities

FDA has issued a new document: “The US Food and Drug Administration (USFDA) Registration of Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act.”

This guidance is intended for facilities planning to register or renew registration as human drug compounding outsourcing facilities (outsourcing facilities). A compounder can elect to register with FDA as an outsourcing facility under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 353b), as added by the Drug Quality and Security Act (DQSA), Pub. Law No. 113-54 (November 27, 2013). This guidance describes the process for electronic submission of establishment registration information for outsourcing facilities. In certain rare cases, FDA may grant an entity a waiver from submitting registration information electronically. This guidance also provides information on how to obtain such a waiver.

For details see: FDA

Posted by Tim Sandle

Guideline on similar biological medicinal products

European Commission have issued a final guideline comes into effect 30 April 2015 although applicants may make use of it prior to that date.

The guideline outlines the general principles to be applied for similar biological medicinal products (biosimilars) as referred to in Directive 2001/83/EC, where it is stated that „the general principles to be applied [for similar biological medicinal products] are addressed in a guideline taking into account the characteristics of the concerned biological medicinal product published by the Agency‟. This Guideline describes and addresses the application of the biosimilar approach, the choice of the reference product and the principles for establishing biosimilarity.

For details see: biosimilars

Posted by Tim Sandle

EMA - health based exposure limits

EMA have issued the following document: “Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities.”

The objective of this guideline is to recommend an approach to review and evaluate pharmacological and toxicological data of individual active substances and thus enable determination of threshold levels as referred to in the GMP guideline. These levels can be used as a risk identification tool and can also be used to justify carry over limits used in cleaning validation.

The document is effective from 1^st June 2015.

For details see: EMA

Posted by Tim Sandle

Regulatory changes impacting on pharmaceutical microbiology

2014 saw a number of important regulatory changes impacting upon pharmaceutical microbiology.

These have included:

• New cleanroom monitoring draft standards
• EMA guidance on analytical method validation
• EU GMP chapters on validation and qualification
• International agreement on endotoxin testing
• USP guidance chapter on depyrogenation

Tim Sandle has written a review of these key changes for European Pharmaceutical Review. The reference is:

Sandle, T. (2014) Review of regulatory changes impacting on pharmaceutical microbiology, European Pharmaceutical Review, Issue 6, pp37-40

The article can be accessed for free (although registration is required for the website) here.

Posted by Tim Sandle

Top Microbiology Articles

Listed below are the top microbiology news articles posted on this website during the past year. Enjoy.

Antibiotic classification
Ten Rules of Good Manufacturingg Practiractice
USP Chapter 1115 Bioburden Control
New Process Validation Guideline (EMA)
Controlling antimicrobial resistance
Guidance to Inspectors on Assessing Quality Risk M...
Compounding Sterile Preparations
New book: Cleanroom Microbiology
A new standard for bioburden testing
Propionibacterium acnes and clear skin

Posted by Tim Sandle