Monday, 31 August 2015

Considerations of melanocytic nevi in children

A paper of interest:

The incidence of melanocytic nevi is increasing, and nevocytic nevi are commonly encountered in childhood. Therefore, the study of these tumors, particularly those that are likely to become malignant, represents an important issue. This paper presents clinical, statistic and structural data on the melanocytic nevi in children, and of adjacent areas when the nevi were surgically excised. The study was made possible by collaboration with the specialty medical stuff of Children Clinic Hospital Braşov. The analysis of the melanocytic nevi was retrospective in relation to 30 patients. These cases were selected from the cases investigated in the first half of 2013. The pathological anatomy diagnosis was conducted following a biopsy of the fragments of melanocytic nevi excised by surgery. This took place within the plastic surgery department of the Children Clinic Hospital Brasov.

The reference is:

Cheşcă, A., Luculescu, M.C., Sandle, T. (2015) Considerations of melanocytic nevi in children, Annals of the Romanian Society for Cell Biology, 19 (2): 19 - 22 doi: 10.ANN/RSCB-2015-0001:RSCB

The paper can be accessed here.

Posted by Tim Sandle

Patterns of microbial diversification

James O'Dwyer  (Carl R. Woese Institute for Genomic Biology) has produced a series of microbial family trees with distinct evolutionary patterns. He has sorted sequence data into a new kind of family tree (phylogenetic tree) that displays patterns of diversification. Diversification includes 22 microbial communities, chosen to represent a breadth of habitat types: plant, marine, and human gut and skin.

For further details see:

James P. O’Dwyer, Steven W. Kembel, Thomas J. Sharpton. Backbones of evolutionary history test biodiversity theory for microbes. Proceedings of the National Academy of Sciences, 2015; 112 (27): 8356 DOI: 10.1073/pnas.1419341112

Posted by Tim Sandle

Sunday, 30 August 2015

Free webinar on ISO 14698

ISO 14698: Learn about general principles and methods of biocontamination control in cleanrooms according this ISO norm and also about the validation of an agar plate active microbial air sampler.

The ISO 14698 part of the webinar is led by Dr Tim Sandle

The air-sampler validation part is led by Anne Connors, Field Marketing Manager, Merck Millipore.

The webinar will allow time for questions.

To sign-up for the event, see Merck Millipore.

Live webinar on the validation of an agar plate active microbial air sampler according to ISO 14698

Posted by Tim Sandle

Nanoscale antimicrobials

North Carolina State University researchers have developed an effective and environmentally benign method to combat bacteria by engineering nanoscale particles that add the antimicrobial potency of silver to a core of lignin, a ubiquitous substance found in all plant cells. The findings introduce ideas for better, greener and safer nanotechnology and could lead to enhanced efficiency of antimicrobial products used in agriculture and personal care.
In a study published in Nature Nanotechnology, NC State engineer Orlin Velev and colleagues show that silver-ion infused lignin nanoparticles, which are coated with a charged polymer layer that helps them adhere to the target microbes, effectively kill a broad swath of bacteria, including E. coli and other harmful microorganisms.

As the nanoparticles wipe out the targeted bacteria, they become depleted of silver. The remaining particles degrade easily after disposal because of their biocompatible lignin core, limiting the risk to the environment.

The researchers used the nanoparticles to attack Escherichia coli, a bacterium that causes food poisoning; Pseudomonas aeruginosa, a common disease-causing bacterium; Ralstonia, a genus of bacteria containing numerous soil-borne pathogen species; and Staphylococcus epidermis, a bacterium that can cause harmful biofilms on plastics — like catheters — in the human body. The nanoparticles were effective against all the bacteria.

For further details see “An environmentally benign antimicrobial nanoparticle based on a silver-infused lignin core” - Nature Nanotechnology (2015)DOI: doi:10.1038/nnano.2015.141

Posted by Tim Sandle

Saturday, 29 August 2015

Antimicrobial copper delivers safer healthcare to South Africa's remote villages

South Africa’s so-called ‘Miracle Trains’ – Transnet’s Phelophepa I and II, which provide healthcare to rural communities across the country – have harnessed the antimicrobial copper to help deliver safer healthcare to millions of people.

The 18-coach trains travel for 35 to 36 weeks of each year, visiting a different community every one to two weeks, and with more than 300,000 people using the facilities annually, infection prevention is a high priority. Consequently, they have been equipped with bacteria-killing antimicrobial copper door handles to help provide a more hygienic environment for patients and staff.

Antimicrobial copper cupboard doors will soon be added to the kitchen facilities, and plans are also underway to install antimicrobial copper table tops in some of the clinics.

As reported by Cleanroom Technology. For further details see: CT.

Posted by Tim Sandle

Friday, 28 August 2015

EMA consults on antibiotics and farm animals

The European Medicines Agency is currently running an important public consultation on how best to assess the risks of antimicrobial resistance passing from food animals to human. The consultation is open until 31st August.

Draft guidelines have been prepared which are designed to help regulators assess the risks associated with individual antimicrobials when they are licensed or their licenses are reviewed.

There are several associated concerns, as previously reported. These include risks to human health (some of the antibiotics used on farm animals could cause harm.) A second reason is that the use of such antibiotics unnecessary promotes antibiotic resistance among certain types of bacteria, especially given that the administration cannot be securely controlled in relation to the external environment.

A third concern is that farm workers can become exposed to antibiotic resistant strains of bacteria, especially via the nose, and that these can be taken by the farm workers home to the their families.

The consultation is based around a draft paper "Guideline on the assessment of the risk to public health from antimicrobial resistance due to the use of an antimicrobial veterinary medicinal product in food producing animals."

Posted by Tim Sandle

Thursday, 27 August 2015

Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

ICH has issued a final version of its questions and answers relating to ICH Q7. According to ICH:

“The Guideline reached Step 4 of the ICH process on June 2015. Experience gained with the implementation of the ICH Q7 Guideline since its finalisation in 2000 shows that uncertainties related to the interpretation of some sections exist. Technical issues with regard to GMP of APIs – also in context with new ICH Guidelines - are addressed in this Question and Answer document in order to harmonise expectations during inspections, to remove ambiguities and uncertainties and also to harmonise the inspections of both small molecules and biotech APIs.”

To access the document, go to: ICH.

Posted by Tim Sandle

Wednesday, 26 August 2015

FDA guidance on Size, Shape, and Other Physical Attributes of Generic Tablets

FDA has issued final guidance regarding Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules.

The guidance is intended to address concerns that differences in size, shape, and other physical characteristics between generic tablets/capsules and the reference listed (brand) drug (“RLD”) may affect patient compliance and acceptability of medication regimens or could lead to medication errors.

According to the guidance:

“While generic formulations of these drug products are required to be both pharmaceutically and therapeutically equivalent to a reference listed drug (RLD), we are concerned that differences in physical characteristics (e.g., size and shape of the tablet or capsule) may affect patient compliance and acceptability of medication regimens or could lead to medication errors. We believe these patient safety concerns are important, and we are recommending that generic drug manufacturers consider physical attributes when they develop quality target product profiles (QTPPs) for their generic product candidates.”

To access the guidance, see FDA

Posted by Tim Sandle

Tuesday, 25 August 2015

FDA draft guidance on injectable volume excess

The U.S. Food and Drug Administration (FDA) has issued a new draft guidance document. This guidance clarifies FDA requirements and regulations pertaining to allowable excess volume in injectable vials and reinforces the importance of appropriate fill volumes and labeled vial fill sizes for injectable drug and biological products.

The guidance can be accessed here: FDA

Posted by Tim Sandle

Monday, 24 August 2015

Pharmaceutical Microbiology: Essentials for Quality Assurance and Quality Control

This book provides pharmaceutical microbiologists with everything they need to know, from regulatory filing and GMP information, to laboratory design and management, compendia tests, and the risk assessment tools and techniques for both sterile and non-sterile products.

Posted by Tim Sandle

Sunday, 23 August 2015

Cleanroom Microbiology Book

Posted by Tim Sandle

Guidance for importers of medicinal products

The European Medicines Agency has issued a new concept paper “Guidance for importers of medicinal products.”

The paper poses and addresses the following problem statement:

“The increased complexity of supply chains and the observation that most GMP non-compliance statements uploaded into EudraGMDP pertain to third country manufacturers have created new areas where further guidance is desired by both the regulators and the industry. In particular, the requirements applicable to importers of medicinal products and concerning the application of GMP requirements, which are traditionally oriented to activities performed at true manufacturing sites.”

To review the paper, go to EMA.

Posted by Tim Sandle

Saturday, 22 August 2015

FDA Releases Isolate-Level Data for Common Gut Bacteria

FDA Releases 18 Years of Isolate-Level Data for Common Gut Bacteria

In a move to make its data more transparent and promote scientific research, the US Food and Drug Administration (FDA) is releasing 18 years of data on several bacteria, collected as part of the National Antimicrobial Resistance Monitoring System (NARMS).

For more details see: Regulatory Affairs Professionals Society

Posted by Tim Sandle

New links between gut microbes and mental health in children

Interesting microbiome news from Genscript:

As we learn more about the human microbiome, evidence keeps mounting that the 'Gut-Brain Axis' enables our intestinal bacteria to influence our mood and mental health:
A recent study in Brain, Behavior, and Immunity finds that differences in gut microbiome composition are associated with differences in temperament in healthy toddlers.
A new study in Pediatric Research finds an association between early probiotic intervention and the risk of neuropsychiatric disorders (ADHD and Asperger syndrome) later in childhood.
A new review discusses new evidence from epidemiology an animal studies on bidirectionality of gut-brain communication across development and efforts to prevent or treat psychological disorders by modifying intestinal flora.

Posted by Tim Sandle

Friday, 21 August 2015

Road Map for Addressing Quality and Manufacturing Challenges

The primary difficulty pharmaceutical companies are forced to grapple with is how to accelerate the time it takes for a product to get from R&D to patients in need. In an effort to face this challenge, prominent pharmaceutical companies are placing increased emphasis on manufacturing and quality management improvements. In fact, most pharmaceutical manufacturers are finding that a holistic, comprehensive approach to quality can transform a company’s quality management system (QMS) from a burdensome necessity to a competitive advantage. To help you achieve similar goals, LNS Research has produced a free, comprehensive eBook that serves as a guide through the numerous impediments your company deals with every day in the struggle to manage an efficient and compliant quality system.

To address these issues, LNS Research has put together an eBook. To access the book, go to: Road Map.

Posted by Tim Sandle