Friday, 29 November 2024

Spirulina: Quest for new medicines


 Image: Spirulina powder, from the genus Arthrospira 

( By John Alan Elson - http://www.3dham.com/protist/spirulina.htm, CC BY-SA 3.0, https://commons.wikimedia.org/w/index.php?curid=47098390)

A biotechnology company has sought to re-invent how biologic drugs are invented by using patented technology to adapt the food algae spirulina to deliver therapeutic proteins1. Spirulina (Arthrospira platensis (Nordstedt) Gomont, formerly Spirulina platensis and Spirulina maxima) is a species belonging to the Cyanobacteria class that lives in freshwater lakes with alkaline and warm waters (an oxygenic photosynthetic bacterium). 

 

Spirulina is most commonly utilised as a food supplement in special algal farms in outdoor tanks and bioreactors. Tim Sandle spoke with Lumen Bioscience CoFounder and CEO, Brian Finrow. 


Sandle, T. (2024) Biologic Drugs Are Reinvented To Treat Infectious Disease, Pharmig News #97, pp11-13

 

Read the article here.

 

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

Tuesday, 26 November 2024

Bacillus spizizenii

 

The American Type Culture Collection (ATCC) #6633 bacterium Bacillus subtilis subsp. spizizenii (commonly Bacillus subtilis) has been reclassified as Bacillus spizizenii.

The change was the result of whole genome sequencing and the paper triggering the change was issued in 2020. However, several culture collections (and providers of cultures) were slow to adopt the taxonomic change.

Bacillus subtilis encompassed four subspecies: Bacillus subtilis subsp. subtilis, Bacillus subtilis subsp. inaquosorum, Bacillus subtilis subsp. spizizenii and Bacillus subtilis subsp. stercoris.

As a result of the research, each has become a separate species. Bacillus spizizenii is retained as the strain commonly used by the world’s culture collections for activities including growth promotion testing.

Reference:

Christopher A. Dunlap . Michael J. Bowman . Daniel R. Zeigler. Promotion of Bacillus subtilis subsp. inaquosorum, Bacillus subtilis subsp. spizizenii and Bacillus subtilis subsp. stercoris to species status. Antonie van Leeuwenhoek (2020) 113:1–12
 

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

Monday, 25 November 2024

John Neiger

John Neiger, who was one of the leading technical experts in the field of cleanrooms, clean air devices, and contamination control has sadly passed away.

John was a founder of the company Envair, which was one of the early pioneering firms specialising in clean air devices (including some of the first isolators).

In 1979, John joined the British Standards committee for microbiological safety cabinets and remained an active participant in national and international cleanroom standards development for around 40 years.

As a technical writer, John co-wrote the book ‘Pharmaceutical Isolators' which was published in 2004 (and subsequently updated). John was also the editor of the essential industry journal Clean Air and Containment Review  - CACR (published by Euromed). CACR recorded over 50 issues.

John wrote two chapters for books that I have edited and in turn I was a regular contributor to CACR. He was a wise, incredibly detailed, and knowledgeable professional. He will be sorely missed.
 

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

Saturday, 23 November 2024

Surface Particulate Monitor and Analyser for Clean Environments

Surface Particulate Monitor and Analyser for Clean Environments by Tim Sandle on Scribd

 

This real-time, in-situ, automated surface particulate monitoring system tracks
the accumulation of particulates over time, alerts the operators and people responsible for quality control to contamination incidents early on and also allows classification of contaminants according to physical characteristics. In this paper, we describe the PFO1000 unit, its operating principles and measurements, and provide the first results of field trials of the unit in a real-world situation.


PFO 1000 MONITOR: A REAL-TIME, IN-SITU, AUTOMATED INSTRUMENT FOR MONITORING PARTICULATE FALL-OUT IN CLEAN... by Tim Sandle on Scribd

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

Friday, 22 November 2024

Microbiology and Infectious Disease



Reviewed title: 'Dimer-monomer transition defines a novel hyper-thermostable peptidoglycan hydrolase mined from bacterial proteome'

DOI link: https://doi.org/10.7554/eLife.98266.1

Summary: This study details a method to identify new antimicrobial drugs with therapeutic promise from bacterial datasets, providing clues for discovering alternatives to traditional antibiotics. eLife's editors describe it as a valuable new strategy for identifying novel lysins (a type of enzyme) with antimicrobial activity, and say that it provides solid evidence for the therapeutic potential of two such lysins discovered during the work.

Full eLife press release for further details: 'Harnessing big data helps scientists hone in on new antimicrobials' – https://elifesciences.org/for-the-press/a444a8f0/harnessing-big-data-helps-scientists-hone-in-on-new-antimicrobials

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

Monday, 18 November 2024

The Future of Clean Room Design: Integrating Tech and Innovation for Optimal Performance

                                                                                                    Cleanroom - designed by Tim Sandle

People specializing in clean room design for pharmaceutical plants have eagerly explored possibilities that include tech and innovation, believing that those attributes will prepare the facilities ready for current and future needs. However, creating a well-designed and purposeful space is about more than just ensuring it has a cutting-edge look and shows the company as a well-equipped entity. Which trends have supported these goals? 

 

By Emily Newton


Using AI-Enabled Digital Twins in Clean Room Design


One emerging trend involves executives relying on digital twins to evaluate differences between potential design choices. Changing the location of an entrance or running through various airflow simulations can help people make informed decisions rather than realizing too late that specific ideas they had were more effective in their minds than reality.

Digital twins are highly realistic representations of actual assets or physical spaces, so people can quickly alter these virtual copies to familiarize themselves with the likely effects. Versions with artificial intelligence features have become more recently available. The most advanced versions can provide prescriptive analyses that recommend which actions people should take. Such data can steer them in the right direction when differentiating between various choices, including many that seem extremely similar.

Additionally, AI-powered digital twins can help people determine if now is the right time to invest in certain innovations they believe will positively impact their adaptability and profits. Since a digital twin provides a consistent environment for running simulations, enables users to experiment and see the likely outcomes before finalizing decisions.

For example, a pharmaceutical clean room classification is a numerical designation based on the size and amount of particulate matter. However, the classification system varies on factors such as the associated regulatory body and the country where the company operates. On one commonly used scale, the lower the number, the stricter the associated contamination control. However, other methods concern a letter grade on a four-point scale. Suppose leaders wanted to investigate the technologies required for a Class 3 clean room versus one classified as a Class 4 facility.

Digital twins can clarify what is needed to make a clean room achieve a particular class ranking. It is then easier for executives to plan and justify their investments. 


Centering Clean Room Design on Quality Control


As a facility’s design teams ponder specifics such as pharmaceutical clean room classification and airflow models, they must also examine the bigger picture. How can they make strategic choices that will increase the company’s likelihood of maintaining high quality control?

One possibility is to implement room features to reduce electrostatic discharge. It causes the destruction or degradation of sensitive components. It is particularly problematic for pharmaceutical companies operating both medication and device divisions. If a device such as an insulin pump performs unexpectedly due to an electrostatic discharge issue that occurred in the factory, the associated brand could experience severe reputation-based repercussions.

Some control programs include measures to safeguard equipment or components at risk of damage from electricity that is at least to 100 volts on the human body model, which measures electrostatic discharge from people. That is the most common source, making it necessary for designers to find practical solutions for curbing it. Possibilities such as flooring materials that dissipate or neutralize electrostatic discharge are excellent foundational options in clean room design.

Another innovative quality control-related measure is to install various connected sensors that give managers and other designated personnel real-time statistics about particle counts, occupancy levels and more. Then, they can immediately see if specific conditions could interfere with quality control and respond accordingly before costly outcomes occur. 

 Cleanroom workers - designed by Tim Sandle

Prioritizing Sustainability and Waste Reduction


Many pharmaceutical executives want to capitalize on the many ways to operate more sustainably. That might mean installing solar panels on some of their buildings. Since statistics show the prices for such systems have dropped by 88% in 11 years, that opportunity is an increasingly affordable one. However, resource conservation can occur inside clean rooms, too.

A commonly utilized option is to make the facilities well-insulated, and more energy-efficient as a result. Additionally, decision-makers can select products made from recycled materials and buy used equipment rather than new items when applicable. All those seemingly small measures add up to create meaningful sustainability gains that can inspire peers and position pharmaceutical brands as eco-friendly pioneers to watch.

Alternatively, leaders may determine that automation investments are among the best ways to operate sustainably by reducing waste and remaining more mindful of resource usage. In such cases, people can achieve impactful results without making all-encompassing changes. For example, one high-tech clean room in a pharmaceutical factory has an automated filling station. It palletizes, labels and straps products without human intervention, improving workflows and freeing people up for other tasks.

Although many individuals think of waste as a physical thing to minimize, it also manifests as delays or underutilized skills. When people choose automation to support their sustainability aims in pharmaceutical facilities, they typically find the advantages span further than initially envisioned. 


A Bright Future for Clean Room Design


Although these are some of the most widely applied trends by clean room designers, people can expect to see more of them for the foreseeable future. The performance-centric efforts explored here connect to executives’ desire to remain competitive and meet high expectations in a demanding industry.

 

Pharmaceutical Microbiology Resources (https://www.pharmamicroresources.com/)

Sunday, 17 November 2024

Understanding steam sterilisation failures


Dr. Tim Sandle discusses some of the common issues encountered in the sterilisation of surgical instruments, using autoclave technologies. He argues that to make a thorough evaluation of sterilisation, reliance cannot be restricted to chemical or biological indicators, and a complete understanding of hazards and physical operating parameters is required.

Staff working in decontamination services will ensure that reusable medical devices, such as endoscopes and other surgical instruments and equipment are cleaned, sterilised, and repackaged to high standards. 

This article can be read at the Clinical Services Journal webpage (registration is required).

The reference is: 

Sandle, T. (2024) Understanding steam sterilisation failures, Clinical Services Journal, 23 (10): 33-37

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

Saturday, 16 November 2024

Endospores and mechanisms of resistance


 Image created by Tim Sandle

Endospores present a concern in controlled environments due to their resistance and indefinite survivability. The production of a spore is part of a sophisticated stress response. Here, the bacterial genome is copied and transferred into the safety of a spore (sporulation).

The spore remains dormant until environmental conditions improve. When conditions are favorable, the spore will germinate (generally rapidly) and become a functioning, vegetative cell.

This week’s article looks at what endospores are, how they are formed, and their relative resistance as part of improving our understanding of contamination control.

See:  https://www.linkedin.com/pulse/resistance-so-futile-endospores-mechanisms-tim-sfaxe/  

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

Saturday, 2 November 2024

Evolution of Pseudomonas aeruginosa

 

Two hundred years ago, give or take the odd decade, Pseudomonas aeruginosa was an environmental bacterium (1), apparently not one, as far as medical records in the pre-microbiology days can be discerned, associated as a human pathogen (2).

Today, P. aeruginosa is associated with a high number of multidrug-resistant infections (3), many of which are nosocomial. Those especially vulnerable to the bacterium are people with underlying lung conditions.

It is estimated that P. aeruginosa is responsible for communicable diseases leading to over 500,000 deaths per year around the world, of which over 300,000 are associated with antimicrobial resistance (AMR). People who are immunocompromised as a result of conditions such as COPD (smoking-related lung damage), cystic fibrosis (CF), and non-CF bronchiectasis, are particularly susceptible.

This week’s article looks at the bacterium and also highlights some new research that charts how the organism evolved rapidly and then proceeded to spread globally over the last 200 years. At the heart of this are changes in human behavior. 

See: https://www.linkedin.com/pulse/200-year-old-problem-evolution-multi-drug-resistant-tim-lqn4e/  

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

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