Wednesday, 22 October 2014

Scientists Discover an On/Off Switch for Aging Cells

Scientists at the Salk Institute have discovered an on-and-off “switch” in cells that may hold the key to healthy aging. This switch points to a way to encourage healthy cells to keep dividing and generating, for example, new lung or liver tissue, even in old age.

In our bodies, newly divided cells constantly replenish lungs, skin, liver and other organs. However, most human cells cannot divide indefinitely–with each division, a cellular timekeeper at the ends of chromosomes shortens. When this timekeeper, called a telomere, becomes too short, cells can no longer divide, causing organs and tissues to degenerate, as often happens in old age. But there is a way around this countdown: some cells produce an enzyme called telomerase, which rebuilds telomeres and allows cells to divide indefinitely.

In a new study published September 19th in the journal Genes and Development, scientists at the Salk Institute have discovered that telomerase, even when present, can be turned off.

Posted by Tim Sandle

Tuesday, 21 October 2014

Analytical & Bioanalytical Testing

Effective analytical instruments, methods, and testing services are vital to all phases of drug development. In this special e-book experts explain methods of identifying viral contaminants, assays for comparability testing of biosimilars, method transfer, data management, and assessing protein purification.

This is the basis of a new, free e-book from BioPharm

The book contains the following articles:
  • Viral Contamination: The Challenge of Finding the Unknown
  • Testing the Quality, Safety, and Efficacy of Insulin Biosimilars
  • Keys to Successful Method Transfer
  • Standardizing Data Management
  • Using the Purity Quotient Difference to Assess Protein Purification

For details, see BioPharm

Posted by Tim Sandle

Cleanroom Clothing Practices in the Healthcare and Pharmaceutical Sector

Pharmig presents:
Cleanroom Clothing Practices in the Healthcare and Pharmaceutical Sector
Tuesday 28th October 2014
Best Western Plus Windmill Village Hotel, Golf & Spa, Coventry

09.00 – 09.30                       Registration with tea/coffee
09.30 – 09.45                       Chairs introduction
                Dr. Tim Sandle – BPL and Pharmig Committee Member

09.45 – 10.30                       Microbiological regulatory aspects of garments and gloves
                                                Speaker: Greg Cochran – Micronclean

10.30 – 11.15                       Microbiological risk to cleanrooms and disinfection
-          Cleanrooms
-          Contamination and contamination sources
-          Selecting detergents and disinfectants
                                                Speaker: Dr. Tim Sandle – BPL & Pharmig Committee Member

11.15 – 11.45                       Morning break with tea/coffee

11.45 – 12.30                       Cleanroom garments for effective ongoing contamination control
                                                -      Personnel contamination and Regulatory Authority requirements
-          Requirements for effective cleanroom garments and assessment for garment lifetime
-          Gowning procedures and validation
-          Garments and cleanroom energy considerations
                                                Speaker: Tim Eaton – AstraZeneca

12.30 – 13.30                       Lunch

13.30 – 14.15                       Gloves and standards
-          What are the ideal properties of gloves for aseptic properties
-          Weaknesses of gloves
-          Use of gloves in isolators
-          Comparisons between American and European standards
-          Chemical and microbiological testing
-          Cytotoxic testing
-          Practical approach to gloves and standards
                Speaker: Mark Oldcorne – Wrexham Maelor Hospital

14.15 – 15.00                       Validation and Application of Hand Hygiene Products
                Speaker: Laura Guardi – ECOLAB

15.00 – 15.20                       Afternoon break with tea/coffee

15.20 – 16.00                       Q&A with the Expert Speaker Panel & Conducting a Cleanroom Clothing Survey
This session will be dedicated to delegates where they can ask speakers additional                                                                                questions relating to Cleanroom Clothing issues.                                          
                                                We also ask that within this session you kindly take the time to complete a questionnaire                                                    on Cleanroom Clothing –the aim of which is to look to produce a ‘Best Practice and Issues                                                   around Cleanroom Clothing in the Healthcare and Pharmaceutical Sectors’ as an article                                                                     and/ or publication

16.00 – 16.15                       Chair’s closing remarks

For details contact Pharmig

Posted by Tim Sandle

Monday, 20 October 2014

Exploring pulmonary pathology

The test of the pulmonary function represents an auxiliary method for the specialty medical examination the patient to determine if there are signs and symptoms relevant to a pulmonary pathology. This is the basis of a new article by Antonella Chesca and Tim Sandle.

The abstract runs:

“This study evaluates the respiratory parameters associated with pulmonary diseases. The study was centred on a comparative evaluation of the pulmonary function during the same two periods of two different years: January - February 2013 and January – February 2014. The data was analysed and comparison was undertaken between the severity of the pulmonary diseases symptoms requiring spirometries, during the cold season in two succeeding years. The study applied to symptomatic patients suffering from COPD or asthma who were referred to the Specialty Outpatient Department of the Pneumophthisiology Hospital of Brasov. To determine the diagnosis and to apply the appropriate medication, the study examined the function tests by spirometry for each of the patients in the study group. As applicable, spirometry was carried out by tests using salbutamol, according to the orders of the specialty doctor. The analysis of the study data enabled the creation of the profile of the symptomatic patients.”

The reference is:

Chesca, A. and Sandle, T. (2014) Data on the examination of functions in pulmonary disease, Acta Medica Transilvanica, 2 (3): 208 – 210

For a copy, please contact Tim Sandle

Posted by Tim Sandle

Antibiotic resistance continues to rise

“Antibiotic resistance continues to rise,” BBC News reports as, despite warnings, the number of antibiotic prescriptions in the UK continues to soar, as do new cases of resistant bacteria.

The news follows the publication of a new report by Public Health England on the English surveillance programme for antimicrobial utilisation and resistance (ESPAUR), which reports the change in antibiotic prescribing and resistance over recent years.

The report highlights a number of key findings, including a year on year increase in antibiotic prescribing in England, with the majority of antibiotic prescribing taking place in general practice. There also seems to be variation across the UK, with areas with higher antibiotic prescribing also having higher rates of resistant infections.

Public Health England hopes this report will enable general practices and hospitals to compare their data with regional and national trends. They could then see if their rates are higher than other areas, and investigate why and if they can reduce these. This will also provide a baseline measure from which to track changes in both prescribing and resistance in England.

Posted by Tim Sandle

Sunday, 19 October 2014

Entire genome of a Klebsiella pneumoniae strain sequenced

Microbiologists, for the first time, recently sequenced the entire genome of a Klebsiella pneumoniae strain, encoding New Delhi Metallo-beta-lactamase (NDM-1).

Assembling an entire genome is like putting together a puzzle. Klebsiella pneumoniae turned out to have one large chromosome and four plasmids, small DNA molecules physically separate from and able to replicate independently of the bacterial cell's chromosomal DNA. Plasmids often carry antibiotic resistant genes and other defense mechanisms.

The researchers discovered their Klebsiella pneumoniae bacteria encoded 34 separate enzymes of antibiotic resistance, as well as efflux pumps that move compounds out of cells, and mutations in chromosomal genes that are expected to confer resistance. They also identified several mechanisms that allow cells to mobilize resistance genes, both within a single cell and between cells.

For further details, see:

Corey M. Hudson, Zachary W. Bent, Robert J. Meagher, Kelly P. Williams. Resistance Determinants and Mobile Genetic Elements of an NDM-1-Encoding Klebsiella pneumoniae Strain. PLoS ONE, 2014; 9 (6): e99209 DOI: 10.1371/journal.pone.0099209

Posted by Tim Sandle

Saturday, 18 October 2014

Fostering Cooperation and Strengthening Medical Product Regulatory Systems in the Americas

From the FDA:

Office of International Programs (OIP) has announced the availability of grant funds for the support of a single source cooperative agreement to the Pan American Health Organization (PAHO) for fostering cooperation and strengthening medical product regulatory systems in the Americas. The goal of the cooperative agreement is to build upon existing cooperation between OIP/FDA and PAHO to foster regulatory collaboration and strengthen regulatory capacity throughout the Americas.

See: FDA

Posted by Tim Sandle

Friday, 17 October 2014

FDA Issues New Guidance: Why Your ANDA was Refused?

The FDA has issued two guidance documents intended to assist applicants preparing to submit abbreviated new drug applications (ANDA), clarifying the deficiences that may cause the FDA to refuse-to-receive (RTR) the submissions.

The two guidances included a final guidance on ANDA RTR standards and a draft guidance on ANDA RTR for lack of proper justification of impurity limits.

According to the FDA, between 2009 and 2012, the Office of Generic Drugs refused to receive 497 ANDAs, primarily because the submissions contained serious deficiences.

FDA’s ANDA RTR standards guidance finalizes a draft version of the guidance released in October 2013. In the ANDA RTR impurity limits draft guidance, the FDA describes serious deficiencies in impurity information that could cause FDA to refuse-to-review an ANDA.

According to the draft guidance, typical deficiencies leading to a refuse-to-receive decision include:

(1) failing to provide adequate justification for proposed limits in drug substances and drug products for specified identified impurities that are above qualification thresholds
(2) failing to provide adequate justification for proposed limits for specified identification thresholds
(3) proposing limits for unspecified impurities (e.g., any unknown impurity) that are above identification thresholds. unidentified impurities that are above identification thresholds.

Read the draft guidance here and the final guidance here.

Posted by Tim Sandle

Thursday, 16 October 2014

Using biofilms for society’s advantage

Biofilms are communities of bacteria ensconced in a slimy, but extremely tough, matrix of extracellular material composed of sugars, proteins, genetic material and more. During biofilm formation individual bacteria pump out proteins that self-assemble outside the cell -- creating tangled networks of fibers that essentially glue the cells together into communities that keep the bacteria safer than they would be on their own.

Normally considered a bad thing, biofilms also self-assemble and self-heal. In looking at this, researchers have genetically fused a protein with a particular desired function -- for example, one known to adhere to steel -- onto a small protein called CsgA that is already produced by E. coli bacteria. The appended domain then went along for the ride through the natural process by which CsgA gets secreted outside the cell, where it self-assembled into supertough proteins called amyloid nanofibers. These amyloid proteins retained the functionality of the added protein -- ensuring in this case that the biofilm adhered to steel.

This could be useful in materials science. It could be possible to produce a raw material as a building block, they orchestrate the assembly of those blocks into higher order structures and maintain that structure over time.

For further details see: Wyss Institute for Biologically Inspired Engineering atHarvard.

Posted by Tim Sandle

Wednesday, 15 October 2014

Spherical influenza virion

A spherical influenza virion is an orderly hodgepodge comprised of hundreds of proteins that originate from both the virus and its host. A new mass spectrometry analysis, published in Nature Communications, has yielded the most complete picture to date of the identities, arrangements, and ratios of proteins in influenza virions.

To sort out the virion components, researchers used sensitive mass spectrometry. Comparing the intensities of ion spectra among protein fragments allowed them to quantify the relative abundance of each protein.

For further details, see The Scientist.

Posted by Tim Sandle

Tuesday, 14 October 2014

ISO 14644 – standard list

ISO 14644 is a multi-part cleanroom standard.

ISO 14644 consists of the following parts, under the general title “Cleanrooms and associated controlled environments”:
  • Part 1: Classification of air cleanliness by particle concentration
  • Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration
  • Part 3: Test methods
  • Part 4: Design, construction and start-up
  • Part 5: Operations
  • Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments)
  • Part 8: Classification of air cleanliness by chemical concentration (ACC)
  • Part 9: Classification of surface cleanliness by particle concentration
  • Part 10: Classification of surface cleanliness by chemical concentration
  • Part 12: Classification of air cleanliness by nanoscale particle concentration
  • Part 13: Cleaning of surfaces to achieve defined levels of cleanliness in terms of particle and chemical classifications
  • Part 14: Assessment of suitability for use of equipment by airborne particle concentration
  • Part 15: Assessment of suitability for use of equipment and materials by airborne chemical and surface chemical concentration
The reader should note that there is no 'Part 11' currently in development.

The standards use the following common codes:

APC – Airborne Particulate Cleanliness
SPC – Surface Particulate Cleanliness
AMC – Airborne (Chemical) Molecular Cleanliness
SCC – Surface Chemical Cleanliness
AVC – Airborne Viable Cleanliness
SVC – Surface Viable Cleanliness

Copies are available from national standards agencies.

Posted by Tim Sandle

Monday, 13 October 2014

Sanitation of Pharmaceutical Facilities

Maintaining environmental control including microbiological contamination in a pharmaceutical manufacturing environment is primarily dependent on the facility sanitization program. Sanitization considerations are specific for facility rooms, equipment, and personnel. Sanitization comprises cleaning and disinfection. Cleaning is necessary prior to the application of disinfectant to enable sufficient contact time of the disinfecting agent with the surface.

In a new paper, Tim Sandle provides an introduction to the sanitization and bio-decontamination of pharmaceutical manufacturing facilities. This topic is especially relevant for manufacturing of sterile products.

The reference is:

Sandle, T.  (2014) Sanitation of Pharmaceutical Facilities, Journal of GXP Compliance, 18 (3): 6-10

For details see: IVT

Posted by Tim Sandle

Sunday, 12 October 2014

Photosynthetically productive light distributed to symbiotic microalgae

Iridescent cells in the mantle tissue of giant clams spread light of a wavelength that drives photosynthesis to microalgae that provide nutrition for the animals, the University of Pennsylvania’s Alison Sweeney and colleagues reported in Journal of the Royal Society Interface.

In their paper, the researchers likened the symbiotic system to an electric transformer, “which changes energy flux per area in a system while conserving total energy.” Given this parallel, the authors proposed that the clam system might inspire the development of more efficient and resilient photovoltaic materials.

These so-called iridocytes not only distribute photosynthetically productive light to the algae, they also reflect nonproductive light, the researchers showed. “At incident light levels found on shallow coral reefs, this arrangement may allow algae within the clam system to both efficiently use all incident solar energy and avoid the photodamage and efficiency losses,” the researchers wrote in their paper.

Source: The Scientist

Test for carbapenem-resistant Enterobacteriaceae

Researchers from Oregon State Public Health Lab have modified the protocol for a relatively new test for a dangerous form of antibiotic resistance, increasing its specificity to 100 percent. Their research, confirming the reliability of a test that can provide results in hours and is simple and inexpensive enough to be conducted in practically any clinical laboratory was presented at the 54th Interscience Conference on Antimicrobial Agents and Chemotherapy, an infectious disease meeting of the American Society for Microbiology.

The test, called Carba NP, originally developed by Patrice Nordmann and Laurent Poirel at the University of Fribourg, Switzerland, and Laurent Dortet of the University Hospital of the South-Paris Medical School, France, allows for rapid identification of carbapenem-resistant Enterobacteriaceae (CRE).

For further details, see: ASM

Posted by Tim Sandle

Saturday, 11 October 2014

Water-based rapid test for total aflatoxin launched

Romer Labs®, a food-safety diagnostic company, has introduced a new method: the AgraStrip® Total Aflatoxin Quantitative WATEX test kit. The new water-based method allows food, feed and grain producers to test for aflatoxins without using organic solvents, such as methanol, which are expensive, flammable, and must be disposed as hazardous waste.

Aflatoxins are naturally occurring mycotoxins that are produced by Aspergillus flavus and Aspergillus parasiticus, species of fungi. High-level aflatoxin exposure produces an acute hepatic necrosis, resulting later in cirrhosis, or carcinoma of the liver. Acute hepatic failure is made manifest by hemorrhage, edema, alteration in digestion, changes to the absorption and/or metabolism of nutrients, and mental changes and/or coma.

Additionally, the test kits have been significantly improved to simplify the ease of- use and to speed up the workflow. With the new dissolvable and pre-weighed extraction buffer bags no time-consuming or difficult buffer preparations steps are needed. No filtration or centrifugation step is needed due to innovative extraction equipment that is included in each test kit, making the use of additional extract clarification obsolete.

With a quantitation range of 0-100 ppb, a limit of detection of 3ppb and a total time-to-results of 8 minutes including extraction, sample preparation and strip test development, the AgraStrip® Total Aflatoxin Quantitative WATEX test kit is the fastest test available on the market, meeting the industry needs for a simple, sensitive and easy-to-use test kit.

“With our new AgraStrip Watex test kit line we fulfill the needs of our customers for an environment-friendly water-based testing method. At the same time we have further simplified the extraction and sample preparation with work-flow innovations offering customers a testing solution that is accurate, easy-to-use and delivers results fast”, states Michael Prinster, CEO of Romer Labs America.

Over the next months, the new AgraStrip® WATEX test kit line will be further
expanded to cover regulated mycotoxins.

For further details see: Romer

Posted by Tim Sandle