GMP Validation - a book to guide you through the international requirements

Within the pharmaceutical and healthcare sector, validation and qualification form an important part of the quality system. However, understanding the differences between different regulatory agencies and the recommendations of different standards can be a bewildering project. This book seeks to provide a map and a compass for navigating the choppy waters of international regulations.

Available via Euromed

GMP Validation provides a text for those who need to assess validation and ensure that validation is conducted according to current GMP. These include the validation manager and personnel engaged in validation activities; quality assurance; quality control; R&D; and production personnel. Some of the scientific aspects will also appeal to students, especially those working within or aspiring to enter the pharmaceutical sector. The book also serves as a good starting point for those who are tasked with auditing validation systems or items of equipment or processes.

This comprehensive handbook is comprised of 30 chapters which are divided into two parts. The first part is dedicated to the management process, with an emphasis upon appropriate formality and risk-based approaches. The second part focuses on case studies, providing an overview of different GMPs and standards for different areas of validation and qualification. The book concludes with four useful appendices providing templates to aid the reader.

Part A: Essential tools for the validation manager

 
1. Qualification, Validation and the Formalised Approach
2. Validation Documentation
3. Hazard Identification and Assessment of Risk
4. Validation Project Management and Risk-based Problem Solving
5. The V-model and the Lifecycle Approach to Validation
6. Quality Risk Management and the Validation Process
7. Data and Statistics for the Validation Manager
8. Validation Errors: Concept and Case Study
9. Calibration Process and Setting Calibration Criticality
10. Setting the Standards for New Equipment Purchases
11. Process Validation: Maintaining Quality and Compliance

Part B: Case studies and GMP concepts for validation

 
12. Audit and validation requirements of single-use technologies
13. Containment system integrity: microbial challenges for sterile products
14. Cleanroom design, commissioning and verification
15. Qualification of disinfectants
16. Utility Design and Qualification for Efficient Pharmaceutical Operations
17. Pharmaceutical Water Systems
18. Equipment Design: Assessing Cleaning and Hygiene
19. Autoclaves and Steam Sterilisation
20. Pure Steam for Sterilisation
21. Cleaning Validation: Balancing GMPs and Risk
22. Compressed Air and Other Gases
23. Data Loggers and Temperature Mapping
24. Microbiological Method Validation
25. Data Integrity and Qualification
26. Isolator Sterility Validation
27. Analytical Method Development
28. Analytical Method Transfer
29. Computerised System Software Validation
30. Sterile Filter Validation

Part C: Appendices

 
Appendix 1: Validation Master Plan.
Appendix 2: IQ Protocol.
Appendix 3: OQ protocol.
Appendix 4: New equipment risk assessment.

Available via Euromed 

 

About the Author

 
Tim Sandle originally trained as a parasitologist before moving into microbiology. He took first degrees in microbiology and politics, and then proceeded to study for a master’s degree and a PhD part-time. Tim is currently Head of GxP Compliance and Sterility Assurance at Bio Products Laboratory. He is additionally a visiting tutor at the University of Manchester and University College London lecturing in pharmaceutical microbiology. He is a longstanding committee member of Pharmig and has served on several other international committees and editorial boards. Tim has written a number of books, and numerous papers, and technical articles relating to GxP concerns, microbiology and contamination control.

Available via Euromed 

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

Defining governance

What is governance? The meaning and application will depend on the context and the organisation.

Here are some examples:

1. United Nations:

“the process of decision-making and the process by which decisions are implemented (or not implemented. Governance can be used in several contexts such as corporate governance, international governance, national governance and local governance.”

Source:  United Nations Economic and Social Commission for Asia and the Pacific (http://www.unescap.org/pdd/prs/ProjectActivities/Ongoing/gg/governance.asp)

2. World Bank:

"the exercise of political authority and the use of institutional resources to manage society's problems and affairs."

Source: World Bank (http://wbi.worldbank.org/wbi/topic/governance)

3. Clinical governance:

"a system for improving the standard of clinical practice... Existing activities such as clinical audit, education and training, research and development, and risk management (including complaints) will become part of clinical governance, and it is their resources that will fund it."

Source: Evidence Based Medicine (http://www.medicine.ox.ac.uk/bandolier/painres/download/whatis/WhatisClinGov.pdf)

"Clinical governance is the framework through which all the components of quality, including patient and public involvement, are brought together and placed high on the agenda of each organisation."

" Clinical governance is about ensuring that patients are safe and risks are managed."
Source: NHS Scotland (http://www.clinicalgovernance.scot.nhs.uk/)

4. Corporate governance:

"How a company is managed, in terms of the institutional systems and protocols meant to ensure accountability and sound ethics. The concept encompasses a variety of issues, including disclosure of information to shareholders and board members, remuneration of senior executives, potential conflicts of interest among managers and directors, supervisory structures, etc"

Source: Financial Times (http://lexicon.ft.com/Term?term=corporate-governance)

" The corporate governance framework  should promote transparent and efficient  markets, be consistent with the rule of law  and clearly articulate the division of responsibilities among different supervisory, regulatory and enforcement  authorities. 

In addition: 

 
• The corporate governance framework  should be developed with a view to its impact on overall economic performance, market integrity and the incentives it  creates for market participants and the promotion of transparent and efficient markets
• The legal and regulatory requirements that affect corporate governance practices in a jurisdiction should be consistent with the rule of law, transparent and enforceable
• The division of responsibilities among different authorities in a jurisdiction should be clearly articulated and ensure that the public interest is served
• Supervisory, regulatory and enforcement authorities should have the authority, integrity and resources to fulfil their    duties in a professional and objective manner."

Source: OECD Principles of Corporate Governance 2004 (http://www.oecd.org/dataoecd/32/18/31557724.pdf)

5. Medical governance:

"Medical governance is required to ensure that a medical service remains health-effective and delivers services first  and foremost to the public rather than to its providers. This model of participative medical governance specifies a robust  system by which the public can ensure that information on health-effectiveness is used to ensure quality of service and it  relies on the public's participation at all gradations of service, from the patient and the family caring for the patient all  the way out to national policy, in a horizontal framework. Importantly, this model provides the means by which to identify at an early stage the points where intervention is necessary with poorly performing clinicians and administrators, so  as to protect the public's health and prevent malpractice."

Source:  Tuke Institute (http://www.tukeinstitute.org/Publications/Publications/CD_files/id-1004-cd1.1.pdf)

6. Pharmaceutical:

"a concept which is increasing in both scope and importance.  We know that there is mounting emphasis on patient safety, and on proactive safety management.  We also understand that with emerging market operations growing, so too is the globalisation of safety standards.  With growing regulator and public scrutiny of company performance and enhanced punitive actions, Medical Governance really is at the forefront of the life sciences industry.  Organisations must control and proactively manage medical issues to ensure that the patient and the brand are protected.  It is also vital that an organisation has oversight of local operations, whilst also ensuring consistent global medical standards are applied.  Medical issues must be addressed before they come to the attention of the regulators and the general public."

Source: WCI Group (http://www.wcigroup.com/Pages/Medical-Governance.aspx)

7. Information:

 
"Information Governance ensures necessary safeguards for, and appropriate use of, patient and personal information."

Source: National Health Service (http://www.connectingforhealth.nhs.uk/systemsandservices/infogov)

8. Business:

"The system by which an organisation is directed and  controlled, at its most senior levels, in order to achieve  its objectives and meet the necessary standards of accountability and probity."

Source: The Cadbury Report (http://www.ecgi.org/codes/documents/cadbury.pdf)

9. NHS:

" The systems and processes by which health bodies  lead, direct and control their functions, in order to  achieve organisational objectives and by which they relate to their partners and wider community."

As quoted by the Audit Commission , Corporate Governance in Health Organisations, 2002
Source: Audit Commission  (http://www.audit-commission.gov.uk/nationalstudies/localgov/Pages/improvementtrustpublicservices.aspx)

10. Integrated governance

" Systems,  processes and behaviours by which trusts lead,  direct and control their functions in order to achieve  organisational objectives, safety and quality of service  and in which they relate to patients and carers, the  wider community and partner organisations"
 

Source: Department of Health - Integrated Governance Handbook, 2006 (http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@en/documents/digitalasset/dh_4129615.pdf)

 

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

Ch-ch-ch-ch-changes: Bacteria, mutations & lab testing

 

Determining the presence of bacteria – either to know some cells are present or to target a specific number – requires growth and growth using a culture-based method is expressed by an increase in cells and/or biomass. The basis of many techniques is taking extremely low levels of various microbial types in a sample, and with the provision of suitable nutrients, atmosphere and temperature, enabling these cells to multiply up to levels that are high enough to count or identify.

To sustain microorganisms in the laboratory setting, subculturing is required. Uncontrolled subculturing can lead to temporary variations or to mutations occurring. This can affect the phenotypic properties or genetic nature of the cell.

How do these variations and mutations occur and why do they matter? Turn and face the strange...This week’s article considers culturing, culture media, subculturing, variations and mutations and what the implications are.

To read see: Mutations

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

Ref: https://www.linkedin.com/pulse/ch-ch-ch-ch-changes-bacteria-mutations-lab-testing-tim-z9bze/?published=t 

Microbiome new study: Human ancestral co-evolution

 A new microbiome study of interest.

 

The project concerns the evolutionary roots of human ancestral ethnic group global regionalizations, as involving skin niche microbial communities.

 

In the study, the researchers address humans as “meta-organism” entities—i.e., entangled conglomerates of microbe genomes plus Homo sapiens genomes that have co-evolved through symbiotic mutualism.

 

Here is the abstract:

 

The human armpit microbiome is metabolically entangled with skin cell physiology. This “metaorganism” symbiotic mutualism results in sweat either with or without odor (osmidrosis), depending on host ABCC11 gene haplotypes. Apocrine metabolism produces odorless S-glutathione conjugate that is transferred by ABCC11 transporters into secretory vesicles, deglutamylated to S-Cys-Gly 3M3SH thiol, and exuded to skin surface. An anthropogenic clade of skin bacteria then takes up the thiol and bioconverts it to malodorous 3-methyl-3-sulfanylhexan-1-ol (3M3SH). We hypothesized a familial meta-organism association of human ABCC11 gene non-synonymous SNP rs17822931 interplaying with skin microbiome 3M3SH biosynthesis. Subjects were genotyped for ABCC11 SNPs, and their haplotypes were correlated with axilla microbiome DNA sequencing profiles and predicted metagenome functions. A multigeneration family pedigree revealed a Mendelian autosomal recessive pattern: the C allele of ABCC11 correlated with bacterial Cys-S-conjugate β-lyase (PatB) gene known for Staphylococcus hominis biosynthesis of 3M3SH from human precursor; PatB was rescinded in hosts with homozygous TT alleles encoding ABCC11 loss-of-function mutation. We posit that a C alleleencoding functional ABCC11 is key to delivering host conjugate precursors that shape heritable skinniche conditions favorable to harboring Staphylococcus having genomics of odor thiol production. This provides existential insights into human evolution and global regional population ancestries.

 

The paper is:

 

Stevens, B.R., Roesch, L.F.W.  Interplay of human ABCC11 transporter gene variants with axillary skin microbiome functional genomics. Nature Sci Rep 14, 28037 (2024)

 

Publisher’s link:  https://doi.org/10.1038/s41598-024-78711-w .

 

Figure 6 in the paper provides a handy overview lay summary.

 

The study asks the existential question: who is the evolutionary driver that steered modern humans into becoming such a meta-organism—was it people or microbes?  How has survival advantage steered the ancient human origins of geographic regional clustering of ancestral ethnic groups with signature microbiomes?  

 

The data center focuses on the key role of a microbe unique to humans, Staphylococcus hominis, and its engineering of “selfish gene” propagation opportunities by way of steering social interactions and communicable contacts among it’s human hosts whom are relegated as mere Trojan horse delivery vessels and incubators subserving their microbial companions. 

 

Within an extended family tree, this bacterial species is either inherited or not inherited by individuals, as governed by SNP variants of the human ABCC11 gene responsible for body odor vs. no odor binary pheromone communication.

 

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

Interplay of human ABCC11 transporter gene variants with axillary skin microbiome functional genomics by Tim Sandle on Scribd

Ensuring Sterility in Pharmaceutical Milling Processes

 

Particle size is critical to a pharmaceutical product’s effectiveness. Consequently, milling is a crucial process for drug manufacturers, but any amount of physical contact introduces cross-contamination concerns in this industry. As drugmakers consider how these workflows meet particle size and efficiency needs, they must also ensure sterility.

 

By Ellie Gabel  

Historically, meeting high standards of cleanliness and sanitation has led to complications and high costs in pharmaceutical manufacturing. Today, new technologies let pharma companies ensure sterility while minimizing production time and expenses. These innovations can apply to milling before, during and after the actual grinding phase.

Preventing Cross-Contamination Before Milling

Pharmaceutical sterility begins with preventing contaminants from entering the workspace in the first place. Contact between equipment and materials cannot produce cross-contamination if no microbes, dirt or other pollutants ever reach the machinery.

Creating a reliable clean room environment is crucial. Airflow is one of the most critical considerations here. Laminar flow will keep contaminants out by pushing inside air in one direction to move it away from sensitive equipment and toward filters. All clean room HVAC systems should include HEPA filters, which can remove 99.97% of airborne pollutants of 0.3 microns or larger.

Internet of Things (IoT) sensors can help by monitoring pollutants in real time. As a result, it becomes easier to ensure protective measures are working correctly or enforce sanitary workflow policies. IoT solutions can also track equipment maintenance to help HEPA filters and other sanitation machinery remain in acceptable condition for longer.

Using Contamination-Resistant Milling Methods

The pharmaceutical milling process itself can adapt to become more contamination-resistant, too. While manufacturers often choose methods based on particle size and efficiency needs, some systems provide sterility benefits over their alternatives.

Conical grinding may be the most common option, but micronization minimizes contamination risks by producing no heat and can achieve smaller particle sizes. In instances where drug classes are incompatible with this method, manufacturers could use cryogenic grinding, which has similar temperature-related benefits. These more advanced solutions may incur higher upfront costs, but they often produce better results and higher efficiency, which can make up for the investment over time.

The optimal method depends on the drug and manufacturing process in question. Generally speaking, though, wet techniques are preferable to dry alternatives, as they require a contained system. This containment, in turn, minimizes cross-contamination and material loss.

Post-Milling Sterilization

Even with thorough preparatory steps, contamination is still possible. Consequently, pharma manufacturers must also apply post-milling sterilization measures to counteract any sanitation issues that may have arisen in the previous steps.

Physical filtration is a reliable way to remove contaminants from drug solutions after milling. Studies show that 200-nanometer particles easily pass through most readily available sterile filtration solutions, while most bacteria are larger than that. As a result, manufacturers can mill their pharmaceutical ingredients as small as possible so they can pass through such pores while the filters catch pollutants.

Chemical and thermal sterilization may provide additional benefits, but manufacturers should approach them carefully. Many pharmaceuticals are sensitive to heat, and chemicals introduce the risk of unwanted reactions. The optimal solution will depend on the kinds of materials a process is dealing with, and organizations will likely need to use various methods to serve different products’ needs.

Pharma Manufacturers Must Address Sterility at Every Point

Contaminants can enter the pharmaceutical production process at many points. Consequently, manufacturers in this industry must ensure high standards of sterility at each step throughout the workflow. Failure to account for any area could result in far-reaching consequences if the pollution is significant enough.

Technologies like the IoT, novel milling equipment and advanced filtration make sterility easier to achieve than ever before. Businesses must recognize the potential such solutions hold and take advantage of them to stay compliant with rising demands and regulations. Getting ahead of tech trends will also keep organizations competitive in a fast-changing environment.

 

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

Tattoo inks and microbial contamination

This week's article looks at microbial contamination risks associated with tattoo inks and the tattoo process and assesses recently published US FDA guidance: 

https://www.linkedin.com/pulse/tattoos-microbial-infection-risks-tim-sandle-ph-d-cbiol-fisct-eqiue/

Save 50.0% on select products from Colourbing with promo code 50LQ68OG, through 1/5 while supplies last. 

Many tattoo inks are contaminated, although different rounds of laboratory analysis show a degree of variation according to locale and ink source. However, there has been a commonality over the past decade for ~50% of inks found to contain microorganisms (10–80% of unopened commercial tattoo inks are contaminated with microorganisms according to my review of the literature. The populations recovered are up to 3·6 × 10^8 CFU per gram. It should be noted that studies tend to pinpoint higher rates of contamination in North America compared with Europe.

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

The Role of Robotics Programming In Science

The world is changing faster than ever, and robots are leading the charge! They're building our cars, performing surgeries, and even exploring the depths of space. But how do these incredible machines know what to do? The answer lies in the fascinating world of robotics programming, which is the secret code that brings robots to life."

What is Robotics Programming?

Picture that you have a robot friend, but it does not know how to walk or talk. You need to teach it! Robotics programming is like giving your robot friend instructions. These instructions are written in special languages that robots can understand.

To get started with robotics programming, you'll need to learn a programming language. C/C++ are powerful languages that give programmers a lot of control over the robot's hardware. They're often used for tasks that need speed and efficiency, such as controlling robot movements. Python is great for tasks that involve artificial intelligence (AI), like helping a robot recognize objects or make decisions, and Java is good at handling lots of data and complex tasks. It's often used for programming robots that interact with the real world. Some examples include self-driving cars or robots that work in warehouses. Even cooler, new 'no-code' platforms are popping up, making it easier than ever for anyone to try their hand at robotics programming, even without knowing complex languages! To illustrate, Pepper is a humanoid robot often used in customer service roles. PandaSuite allows users to create interactive behaviors for Pepper, such as greeting customers, answering questions, and providing directions, all without coding.

The Role of Robotics Programming in Science

Robotics programming is super important in science because it helps us do incredible things. Scientists use robots to explore dangerous places, such as the deep sea or outer space, where humans cannot easily go. These automatons can also help us with difficult tasks, such as manufacturing products or assisting in surgeries. In car factories, robotic arms weld parts together with pinpoint accuracy to make sure every car is built tough, and when it comes to your phone or computer, tiny robots place the super-small parts onto circuit boards way faster and better than any human could. Even in giant warehouses, robots zoom around, lifting and stacking those huge boxes of stuff like it's nothing. Robots are also being used in STEM education.

What You Should Know About Programming in Robotics

If you think robotics programming sounds exciting, here are some things to keep in mind. First, it involves problem-solving. You need to figure out the best way to tell a robot to complete a task. This can be tricky, but it is also extremely rewarding when you find a solution. Additionally, robotics programming requires creativity. You can program these machines to do all sorts of things, from playing music to drawing pictures. The possibilities are endless! Finally, do not be afraid to make mistakes. Everyone makes mistakes when they are learning something new.

Robotics Programming is Fun!

Robotics programming may sound complicated, but it can be a lot of fun. There are many resources available to help you learn, such as books, websites, and online courses. On top of that, you can even join a robotics club or team to learn from others and work on projects together.

So, there you have it! Robotics programming is a fascinating field that combines technology, science, and creativity. If you are curious and love to solve problems, robotics programming might be the perfect thing for you.

Written by Taylor McKnight, Author for Automation Integration Solutions, LLC
 

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

Diet matters less than evolutionary relationships in shaping gut microbiome

 

Gut microbes provide many services for their hosts, including digesting their food. Researchers have long known that mammals with specialized diets, such as carnivores and anteaters, have special types of gut microbes that allow them to eat that diet.

Is the same true in primates? In the largest published comparative dataset of non-human primate gut microbiomes to date, a new Northwestern University study set out to find whether leaf-eating primates have similar gut microbes that help them break down their leafy diet, which is full of fiber and toxins.

A common theme in the microbiome field is that host diet has large effects on the gut microbiome — both across lifespans (week-to-week changes in host diet change the gut microbiome) and across evolution (mammals with similar diets have similar gut microbes regardless of their evolutionary histories), said Katherine Amato, lead author of the study and assistant professor of anthropology in the Weinberg College of Arts and Sciences at Northwestern.

Therefore, they expected to see many similarities between leaf-eating primates, regardless of how closely related they were to each other. Rather, the researchers discovered that diet mattered much less than host evolutionary relationships in shaping the gut microbiome.

“Our data suggest that, across evolution, the effect of primate diet on the primate gut microbiome is not large,” Amato said. “Evolutionary relationships between primates are much more important for predicting microbiome composition and function.” 

The study is the first cross-species comparison of the gut microbiota that exclusively uses samples from wild animals.

“We conclude that although gut microbes play a critical role in supporting host dietary specializations, their impact is regulated through host physiology,” Amato said.

“Leaf-eating primates shared very few gut microbial characteristics. Instead, New World monkeys shared the most gut microbial characteristics with each other, regardless of diet. The same was true for Old World monkeys, lemurs and apes. These patterns appear to be the result of host physiological traits such as how the gastrointestinal tract is built.”

Cross-mammal examinations of the gut microbiome have been performed, Amato said, but they all had weaknesses in that species with similar diets also had similar evolutionary histories or physiology. Many studies also mixed captive and wild animals, and captivity is known to change the gut microbiome.

“This study was able to eliminate these issues due to the fact that leaf-eating evolved independently multiple times in the order Primates and is associated with a different physiology in each part of the primate tree,” Amato said. “We also only used wild primates, which compared to captive primates, are more likely to have gut microbiomes like those they evolved with.”

Further research could involve looking at more primate species with more varied diets and understanding how the human gut microbiome fits into this bigger evolutionary picture and what it can tell us about our physiology and health, Amato said.

“Evolutionary trends in host physiology outweigh dietary niche in structuring primate gut microbiomes” published online earlier this month in the ISME Journal: Multidisciplinary Journal of Microbial Ecology.

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

Unmasked: The Science Powering Human, Humanized, Chimeric, and Single-Domain Antibodies

 Antibodies, the immune system’s frontline fighters, are nature’s way of keeping pathogens in check. Thanks to biotech innovation, these proteins have been reimagined to tackle everything from cancer to autoimmune diseases. Let’s unpack the fascinating world of engineered antibodies—human, humanized, chimeric, and single-domain—and see how they’re changing the medical game.  

By Bella Smith, Creative Biolabs

Human Antibodies: The Real Deal  

Human antibodies are as close as it gets to the natural defenders produced by your immune system. Fully derived from human genes, they boast unmatched compatibility, significantly reducing the risk of adverse immune responses. Advances like transgenic mice and phage display tech have made producing these antibodies a breeze, making them MVPs in treating chronic conditions and infections.  

Humanized Antibodies: The Perfect Blend  

When it comes to balancing efficacy and safety, humanized antibodies steal the show. Initially generated in animals, these antibodies are modified to replace non-human components with human ones, keeping only the antigen-binding regions intact. This reduces the risk of rejection while maintaining functionality.  

They’ve become a go-to for autoimmune and cancer therapies, ensuring cutting-edge solutions that won’t make your immune system go haywire.  

Chimeric Antibodies: A Best-of-Both-Worlds Hybrid  

Chimeric antibodies are the ultimate mash-up, blending human and non-human regions to maximize both safety and efficacy. By combining a human constant region with a variable region from another species (often mouse-derived), researchers create highly effective antibodies for tough targets.  

This hybrid approach has seen massive success, with drugs like rituximab paving the way for cancer immunotherapies. Chimeric antibody products illustrate the versatility of this design in the clinic.  

Single-Domain Antibodies: Tiny Titans  

Single-domain antibodies, are a stripped-down, no-frills version of the traditional antibody. Sourced from camelids like llamas and alpacas, these mini marvels are small but incredibly mighty. Their compact size lets them access hard-to-reach spots and bind with precision.  

Applications in imaging, diagnostics, and targeted therapies are expanding fast, with products like single-domain antibodies pushing the boundaries of what these tiny proteins can do.  

Antibody Engineering: What’s Next?  

From lab bench to bedside, engineered antibodies are shaking up the medical world. These biotechnological breakthroughs are unlocking new possibilities for personalized medicine, improving outcomes, and delivering hope to patients battling complex diseases.  

With experts like Creative Biolabs offering solutions that span the antibody spectrum, researchers have the tools to push innovation further than ever before. Whether it’s human, humanized, chimeric, or single-domain antibodies, these scientific marvels are rewriting the rules of modern medicine.  
 

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

Innovations in rapid microbiological methods

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

Introduction to sterility assurance (video)

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

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/)

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/)

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/)

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/)