Sunday, 26 January 2025

MicroQuant™ webinar


 
Join us for an insightful webinar on improving microbial quality control testing using MicroQuant™, ATCC's new line of precisely quantitated, single-use, rapidly rehydrating microbial reference strains.

Webinar Topics:

-Review challenges of traditional microbial QC workflows.
-Discuss the development and performance evaluation of MicroQuant™ controls.
-Highlight the benefits of using MicroQuant™ over traditional microbial QC workflows and other single-use microbial controls.

Register now to secure your spot!
https://ow.ly/tL3050UL9c4

 

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

New book: Blood, Plage and Smallpox

 

Elstree is a site of scientific excellence. Starting as laboratories as part of the Lister Institute of Preventative Medicine, research was varied, including pathogen safety and nutrition before the site’s first great success was through playing a pivotal role in the global eradication of smallpox. 

Blood, Plage and Smallpox - a new book from Tim Sandle


From Lister sprung the Blood Products Laboratory, a global innovator in plasma products (including immunoglobulins and the world’s first factor VIII for the treatment of haemophilia).

These three central elements are captured by this book’s title – Blood, Plague, and Smallpox.

This book documents the history of the site – criminals sought out by Scotland Yard; dedicated workers contracting the very pathogens they are experimenting on; periodic political and biological threats to the site remaining open (from Margaret Thatcher to mad cow disease), this is a history of twists, turns, survival and scientific excellence.

Dr. Tim Sandle is a scientist by profession (pharmaceutical microbiology) in addition to being an author of more than 30 books and a journalist. Sandle has authored some 1000 peer reviewed papers and technical articles and he has long been interested in the history of the ‘Elstree Labs’, both as an employee and a lover of history.

The book is available as a hardback, paperback and e-book via Amazon.

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

Saturday, 18 January 2025

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/)

Sunday, 12 January 2025

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/)

Saturday, 11 January 2025

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 

Wednesday, 1 January 2025

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

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