Sunday 28 February 2021

New histology textbook


Histology refers to the study of normal tissues. Tissue represents a group of cells with the same characteristics, and with common roles. A tissue group has a common origin, shape and structure and common functions. We intend to find the usefulness of this material as an aid in learning the notions regarding the structural study of normal tissues, as epithelial, in the human body.

Tim Sandle has contributed to a new book.


 The material aims to present brief information and images of optical microscopy, for the purpose of the study.

The book is structured in chapters.


Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (

Wednesday 24 February 2021

Malaria - note

Malaria is an acute febrile illness. In a non-immune individual, symptoms usually appear 10–15 days after the infective mosquito bite. The first symptoms – fever, headache, and chills – may be mild and difficult to recognize as malaria. If not treated within 24 hours, P. falciparum malaria can progress to severe illness, often leading to death.Children with severe malaria frequently develop one or more of the following symptoms: severe anaemia, respiratory distress in relation to metabolic acidosis, or cerebral malaria. In adults, multi-organ failure is also frequent. In malaria endemic areas, people may develop partial immunity, allowing asymptomatic infections to occur.

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (

Tuesday 23 February 2021

International recommendations for COVID-19 workplace safety


A new ISO standard has been issued, looking at the impact of maintaining business operations in the context of the coronavirus pandemic. The reference for the standard is ISO/PAS 45005:2020, and it is titled ‘Occupational health and safety management — General guidelines for safe working during the COVID-19 pandemic’.


The standard is multi-industry and the focus is with providing guidance to firms for taking effective action to protect workers and other relevant interested parties from the risks related to the novel coronavirus.


There are two key principles to the document:


Reasonable measures must be undertaken by employers to manage the risks arising from COVID-19 are, or will be, implemented to protect the health and safety of workers and visitors;


Workers should not be required to work unless appropriate measures have been implemented.


Central to these principles is with protecting the physical and mental health of workers, be they at the workplace facility, on the road, or working remotely at home.


Tim Sandle has written a review of the standard, looking at the pertinent points and considering the gaps. The reference is:


Sandle, T. (2021) International recommendations for COVID-19 workplace safety, IVT Network, at:


Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (

Monday 22 February 2021

Industry Drivers in the Development of Recombinant Lysate


With recombinant lysate, a recombinant protein is an artificially produced (and often purified) protein. The recombinant process occurs, in general terms, when recombinant DNA encoding a protein is introduced into a host organism to express foreign proteins. This process requires the use of specialized expression vectors together with restructuring by foreign coding sequences.


Tim Sandle has written a review of recombinant lysate for use with the bacterial endotoxin test.


The idea for the use of recombinant lysate is to provide a reagent that reacts in the same way as the natural cascade within the four species of horseshoe crab: (Limulus polyphemus, Tachypleus tridentatus, Tachypleus gigas, and Carcinoscorpius rotundicauda). The cloning technology serves an alternative to the fishing and bleeding of horseshoe crabs (where bleeding is performed through a large dorsal blood sinus called the pericardium). In addition, the use of recombinant technology to substitute the specific pathway seeks to address the concern with some lysates that also detect beta glucans through the activation of factor G. A further advantage with recombinant lysates stems from the production of the test reagent through the use of cell culture.  This may result in the supply of a more consistent product.


From around 2003 recombinant lysate has been commercially available, albeit not recognized by any compendia until 2016. However, it has only been in the past few years that manufacturing has become more consistent and subsequently a number of quality control testing laboratories have been looking into the use of recombinant lysate. This somewhat gradual process is attributable to a clash between drivers (seeking to conserve horseshoe crabs, albeit with the mortality rate an imprecise and often contested figure)4 and points of hesitancy (regulatory uncertainty, lack of standardization, imprecise validation requirements and so on). As of 2021, recombinant lysate will become an established alternative to the traditional LAL test within Europe but within the U.S., when a new chapter appears, a greater level of comparative validation will be required in order to show equivalence. While this disparity is understandable, and this article attempts to show this through a discussion of the historical perspective, the current situation is a disservice to laboratory users. Much of what has been written on rFC to date has looked at things from a U.S.-centric perspective (rather than U.S. and European) and from a supplier or regulatory perspective; this article embraces the laboratory user perspective.


The reference is:


Sandle, T. (2020) Historical Milestones and Industry Drivers in the Development of Recombinant Lysate for Bacterial Endotoxin Testing, American Pharmaceutical Review, at:


Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (

Sunday 21 February 2021

Vaccine shows potential against deadly leptospirosis bacteria

Researchers have reported success with a new protective vaccine that shows considerable potential against deadly leptospirosis bacteria. The disease can cause considerable lung damage.

New research of interest has been published in the journal eLife ("A live attenuated-vaccine model confers cross-protective immunity against different species of the Leptospira genus"). 
This is based on a study that discusses how a single-dose universal vaccine could protect against the many forms of leptospirosis bacteria, which cause life-threatening conditions such as Weil’s disease and lung haemorrhage.  
Leptospira bacteria refers to genus of spirochaete bacteria, including a small number of pathogenic and saprophytic species. The bacteria are flexulous, in terms of being able to bend and wriggle as well as motile, in terms of being able to propel themselves about. It is of medical concern that the disease caused by the bacterium is manifest as a wide range of symptoms, some of which may be mistaken for other diseases. 
The time between exposure to the bacteria which causes leptospirosis and when symptoms first become apparent is 7 to 21 days.

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (

Saturday 20 February 2021

Policy for Testing of Alcohol


The U.S. FDA has issued new guidance in relation to the testing of ethanol and isopropyl alcohol for methanol.


This guidance is of particular importance during the coronavirus pandemic. The guidance is intended to alert pharmaceutical manufacturers and pharmacists in State-licensed pharmacies or Federal facilities who engage in drug compounding to the potential public health hazard of alcohol (ethyl alcohol or ethanol) or isopropyl alcohol contaminated with or substituted with methanol. FDA is aware of reports of fatal methanol poisoning of consumers who ingested alcohol based hand sanitizers that were manufactured with methanol or methanol-contaminated ethanol.


FDA has also received numerous reports of dermal toxicity associated with such products. This guidance was developed by the FDA’s Center for Drug Evaluation and Research (CDER), in cooperation with the Center for Biologics Evaluation and Research (CBER)and the Center for Veterinary Medicine (CVM).


For the purposes of this guidance, references to “manufacturers” include registered outsourcing facilities because outsourcing facilities are subject to current good manufacturing practice (CGMP) requirements. 


FDA also is concerned that other drug products containing ethanol or isopropyl alcohol (pharmaceutical alcohol), which are widely used active ingredients in a variety of drug products, could be similarly vulnerable to methanol contamination. For example, certain inhalation products, mouthwashes, cough and cold products, and many topical drug products include pharmaceutical alcohol.



 Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (

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