Sunday, 29 November 2015

Unified Microbiome Initiative

A consortium of 48 scientists from 50 institutions in the U.S. are calling for a Unified Microbiome Initiative that would span national cross-institutional and cross-governmental agency support. The group, called the Unified Microbiome Initiative Consortium (UMIC), envisions that a coordinated effort would drive forward cutting edge microbiome research.

A Unified Microbiome Initiative to accelerate microbiome research would unlock new insights, speed translation of discoveries into numerous potential technologies for health, industry, and the environment.

The new group aims to look at: understanding how microbes assemble into communities and what makes them resilient or resistant to perturbation, how genes in the microbiome interact with one another, which genes in the microbiome are associated with which organisms, as well as how we can beneficially harness the microbiomes of humans, animals, plants and environments.

For further details see:

A. P. Alivisatos, M. J. Blaser, E. L. Brodie, M. Chun, J. L. Dangl, T. J. Donohue, P. C. Dorrestein, J. A. Gilbert, J. L. Green, J. K. Jansson, R. Knight, M. E. Maxon, M. J. McFall-Ngai, J. F. Miller, K. S. Pollard, E. G. Ruby, S. A. Taha. A unified initiative to harness Earth's microbiomes. Science, 2015; 350 (6260): 507 DOI: 10.1126/science.aac8480

Posted by Tim Sandle

Saturday, 28 November 2015

PDA Technical Report No. 73 Prefilled Syringe User Requirements

Recently released - PDA Technical Report No. 73 (TR 73) Prefilled Syringe User Requirements for Biotechnology Applications discusses the requirements for the 1 mL long glass prefilled syringe (PFS) for biotechnology applications.

Over the past decade, a large number of subcutaneously injected biotechnology drug products have been packaged in PFSs because of the benefits compared to vials or ampules. The benefits of PFSs include reduction of medical dosing errors, reduction in risk of microbial contamination by decreased manipulation prior to injection, and improved compliance due to ease of use. In addition to the patient benefits, PFSs often have lower overfill regulatory requirements than vials, thereby reducing product waste.

This report provides guidance on material selection and evaluation for suitability, syringe preparation and handling (including human factors), and drug product compatibility (physical and chemical) with the syringe materials and mode of delivery. Plastic syringes and ancillary devices, such as autoinjectors, are not within scope.

For further details, see PDA.

Posted by Tim Sandle

Friday, 27 November 2015

Guido Rasi takes office as head of EMA

Professor Guido Rasi has taken office as Executive Director of the European Medicines Agency (EMA) today.

Professor Rasi was nominated as Executive Director for a five-year mandate by the Management Board of the Agency on 1 October 2015. He was appointed following his statement to the European Parliament’s Committee on Environment, Public Health and Food Safety (ENVI) on 13 October 2015.

“I am very happy to be back at the helm of the Agency,” said Professor Rasi on his first day in office. “We are currently undergoing the most significant transformation of the system of medicine development and authorisation that I have seen during my 35-year career in public health, either as a doctor, a researcher or a regulator. It is exciting and challenging to be leading the Agency during this time.”

For further details, see EMA.

Posted by Dr. Tim Sandle

New approach to reduce antibiotic resistance

Researchers have developed a novel mathematical method inspired by Darwinian evolution to use current antibiotics to eliminate or reduce the development of antibiotic-resistant bacteria.

In developing a novel mathematical approach to analyze antibiotic resistance, a research group have shown that the ability of the bacterium E. coli to survive in antibiotics could be either promoted or hindered depending on the sequence of antibiotics given. They discovered that approximately 70 percent of different sequences of 2 to 4 antibiotics lead to resistance to the final drug.

For further details see:

Daniel Nichol, Peter Jeavons, Alexander G. Fletcher, Robert A. Bonomo, Philip K. Maini, Jerome L. Paul, Robert A. Gatenby, Alexander R.A. Anderson, Jacob G. Scott. Steering Evolution with Sequential Therapy to Prevent the Emergence of Bacterial Antibiotic Resistance. PLOS Computational Biology, 2015; 11 (9): e1004493 DOI: 10.1371/journal.pcbi.1004493

Posted by Tim Sandle

Pharmig conference 2015 report

This week the U.K.'s biggest conference dedicated to pharmaceutical microbiology took place in Nottingham. The key themes were risk assessment, coping with aging facilities, and addressing contamination issues. The conference was a success in terms of getting the key messages across: use risk wisely; be proactive about aging facilities; and keep data accurate and secure.

Organized by the Pharmaceutical Microbiology Interest Group (Pharmig), the conference has been taking place for overt twenty years. Pharmig is a not-for-profit microbiology society, organized by a volunteer committee.
The logo screen  welcoming delegates to the Pharmig microbiology conference.
The logo screen, welcoming delegates to the Pharmig microbiology conference.

Read more: by Dr. Tim Sandle

Thursday, 26 November 2015

Antarctic warming stimulates diversity of soil fungi

A new study predicts that climate change will have a major impact on life in Antarctica this century. Scientists say that results indicated that by 2100 there would be 25 percent more soil fungal 'species' in the most rapidly warming parts of Antarctica.

For details see:

Kevin K. Newsham, David W. Hopkins, Lilia C. Carvalhais, Peter T. Fretwell, Steven P. Rushton, Anthony G. O’Donnell, Paul G. Dennis. Relationship between soil fungal diversity and temperature in the maritime Antarctic. Nature Climate Change, 2015; DOI: 10.1038/nclimate2806

Posted by Tim Sandle

Wednesday, 25 November 2015

The Role of Gut Microbiota in Liver Disease

The role of gut microbiota, along with the corresponding translocation of endotoxin into circulation, has been demonstrated for many diseases including Crohn's Disease, ulcerative colitis, HIV and diabetes. A recent publication in the Journal of Clinical Gastroenterology has extended this to liver disease. Using several different mouse models to simulate liver disease, they found significant differences in the microbiome compared to healthy control mice. Several mechanisms for this link were explored, including an increase in gut permeability leading to an increase in circulating endotoxin. Given that Toll-like receptors are required for sensitivity to liver fibrosis, and the role that endotoxin plays in other inflammatory diseases, this is an especially attractive possibility.

Posted by Tim Sandle

Tuesday, 24 November 2015

Identification of Neisseria species

Public health England has issued “UK Standards for Microbiology Investigations ID 6: identification of Neisseria species.”

The genus Neisseria belongs to the family Neisseriaceae. There are currently 25 Neisseria species and 3 subspecies of which may be isolated from humans and animals1. Four species have been reclassified. The clinically important Neisseria species (Neisseria gonorrhoeae, Neisseria meningitidis, Neisseria lactamica and Neisseria cinerea) are relatively easy to identify from the non-pathogenic Neisseria. N. gonorrhoeae and N. meningitidis are the two main pathogens of the group. The other species of Neisseria such as N. lactamica and N. cinerea are generally considered commensals, but have been implicated as causes of infection in patients who are immunocompromised. More recent species to the genus Neisseria are N. oralis, N. shayeganii, N. wadsworthii, N. zoodegmatis and N. animaloris isolated from human clinical samples.

The document provides guidance about the identification of these organisms. To access the document, see Public Health England.

Posted by Tim Sandle

Monday, 23 November 2015

Current Methods and Approaches for Viral Clearance

Tim Sandle has written a discussion article for American Pharmaceutical Review on the subject of viral clearance. The abstract reads:

“Complete viral safety, as defined by absolute freedom from extraneous viral agents, is not easy to achieve and some would argue that it is an impossible task due to the difficulties in testing for the full range of pathogenic viruses and residual pathogenicity. The process is also complicated by viral inactivation being rarely linear. It can also be that viruses are subsequently discovered several years after a batch has been manufactured. Therefore, whilst product testing can support control measures in terms of the showing that the probability of viral contamination is low, greater confidence is garnered through viral clearance strategies and associated risk assessment.

This article assesses the key factors for viral clearance and considers the current methods used to remove viral particles from the product stream.”

The reference is:

Sandle, T. (2015) Current Methods and Approaches for Viral Clearance, American Pharmaceutical Review, September / October 2015: 1-4

For a copy, please contact Tim Sandle

Posted by Tim Sandle

Sunday, 22 November 2015

SfAM Winter Meeting Psychrophilic and Extremophile Microbiology

Microbiology meeting on: Psychrophilic and Extremophile Microbiology, organised by the Society for Applied Microbiology.

19 January 2016
One Great George Street, Westminster, London.
Posted by Dr. Tim Sandle

Technical Guide for the elaboration of monographs

EDQM has released a revised technical Guide for the elaboration of monographs (7th Edition 2015)

For further details see EDQM

Posted by Tim Sandle

Saturday, 21 November 2015

New type of bacteria-powered energy source

As part of the hunt for new types of energy, especially those that are renewable, microbiologists have been examining the properties of marine bacteria. One species, called Cyanothece 51142, is of particular interest.

Read more:

Posted by Dr. Tim Sandle

Friday, 20 November 2015

Engineered Particles 'may become Antibiotics of the Future'

“Due to rising threat of antibiotic resistance, there is a pressing need for new approaches to fight harmful bacteria.” As reported via the Infectious Diseases Newsletter: “Now, researchers have been successful in developing engineered particles called "phagemids" that enter targeted harmful bacteria and release toxins that kill them. In a study, they developed a particle that works by targeting and killing specific bacteria without causing the cells to burst and release their toxins. These particles are "called phagemids" because they infect the target bacteria with plasmids.”

For further details, see Infectious Diseases.

Posted by Tim Sandle

Thursday, 19 November 2015

Pharmacopeial Forum 41 (6)

A new edition of the Pharmacopeial Forum has been issued.  This is volume 41, issue 6, which covers the period November - December 2015.

Highlights include:

Chapter 151 Pyrogen Test
(Revision proposal target, USP40-NF35)

To encourage the use of in vitro alternatives to in vivo animal tests, a revision is proposed to introduce text into the Introduction of the chapter that allows the use of a validated, equivalent in vitro pyrogen or bacterial endotoxin test in place of the in vivo rabbit pyrogen test, where appropriate. There is no impact on any of the monographs that reference this chapter.

Chapter 1790 Visual Inspection of Injections [NEW]
(Revision proposal target, USP40-NF35)

The General Chapters—Dosage Forms Expert Committee proposes this new chapter to provide guidance on the inspection of injectable drug products for visible particles. The methods discussed are also applicable to detection of other visible defects that may affect container integrity or cosmetic appearance of the product. 

Posted by Dr. Tim Sandle

Wednesday, 18 November 2015

WHO Good Data and Record Management Practices

The World Health Organization (WHO) has issued a draft guidance document titled “Good Data and Record Management Practices.” The document is out for public comment.

Medicines regulatory systems worldwide have always depended upon the knowledge of organizations that develop, manufacture and package, test, distribute and monitor pharmaceutical products. Implicit in the assessment and review process is a trust between the regulator and the regulated that the information submitted in dossiers and used in day-to-day decision-making is comprehensive, complete and reliable. Data on which these decisions are based should therefore be complete as well as being accurate, legible, contemporaneous, original and attributable; commonly referred to as “ALCOA”.

The draft discusses the controls necessary for good data management, which include:

A quality risk management approach that effectively assures patient safety and product quality and validity of data by ensuring that management aligns expectations with actual process capabilities. Management should govern good data management by first setting realistic and achievable expectations for the true and current capabilities of a process, method, environment, personnel, technologies, etc.;

Management should continuously monitor process capabilities and allocate the necessary resources to ensure and enhance infrastructure, as required (for example, to continuously improve processes and methods; to ensure adequate design and maintenance of buildings, facilities, equipment and systems; to ensure adequate reliable power and water; to provide necessary training for personnel; to allocate the necessary resources to the oversight of contract sites and suppliers to ensure adequate quality standards are met, etc.). Active engagement by management in this manner remediates and reduces pressures and possible sources of error that may increase data integrity risks;

Adoption of a quality culture within the company that encourages personnel to be transparent in failures so that management has an accurate understanding of risks and can then provide the necessary resources to achieve expectations and data quality standards;

Mapping of data processes and application of modern quality risk management and sound scientific principles across the data life cycle;

Modernization of the understanding of all site personnel in the application of good documentation practices to ensure that the GxP principles of ALCOA are understood and applied to electronic data in the same manner that has historically been applied to paper records;

Implementation and confirmation during validation of computerized systems that all necessary controls for good documentation practices for electronic data are in place and that the probability of the occurrence of errors in the data is minimized;

Training of personnel who use computerized systems and review electronic data in basic understanding of how computerized systems work and how to efficiently review the electronic data and metadata, such as audit trails;

Definition and management of appropriate roles and responsibilities for quality agreements and contracts entered into by contract givers and contract acceptors, including the need for risk-based monitoring of data generated and managed by the contract acceptor on behalf of the contract giver;

Modernization of quality assurance inspection techniques and gathering of quality metrics to efficiently and effectively identify risks and opportunities to improve data processes.

To access the draft see: WHO

Posted by Dr. Tim Sandle