Thursday 28 September 2017

Bacteria busting detergent


Advertorial:

There seems to be no shortage of ways to stay fresh and clean these days—in recent news, everything from MIT biofabrics that leverage living bacteria, to T-shirts made from coffee beans, are claiming to answer the ever-growing problem for workout warriors everywhere- Why Do My Gym Clothes Still Stink Even After I Wash Them?

But what if there was a simple solution that didn’t involve buying expensive, high tech clothing, and was as easy as getting back to basics? We’re referring of course, to your choice of detergent.

HEX Advanced Performance Detergent, founded by a professional lacrosse player Drew Westervelt, targets a big challenge for traditional household legacy detergent brands- today, over 60% of clothing contains synthetic fibers (including and especially athleisure). Mainstream detergents simply weren’t designed to properly clean synthetic fibers- they were created at a time when most clothes were made from cotton.

The result: bacteria from your sweat never fully goes away, even after washing. So it continues to pick up odor over time, and before you know it your $100 pair of Lululemon leggings is ruined!
Case in point: in a test conducted by the International Antimicrobial Council, Lululemon yoga pants were sent to be laundered with 187,000 bacteria on them. After five washes with traditional detergent, they came out of the dryer with a whopping 747,000 bacteria!

And the problem doesn’t just apply to gym clothes. Anything that isn’t cotton is at risk for not being properly washed by traditional brands, meaning you’re literally wasting hundreds of dollars a year (and possibly thousands when you factor in the cost of your clothes) by choosing the wrong detergent.

Hex Performance is sold in over 4,000 stores nationwide, at major retailers like Target, and is available on Amazon.

Wednesday 27 September 2017

Yeast helps hunt for new medicines


Scientists have developed a new way to predict potentially useful drugs from a pool of undefined chemicals. They were able to more quickly identify leads that could be used to treat a range of diseases, from infections, to cancer to Alzheimer's. The finding will also help better match drugs to a disease to maximize the benefit and reduce side-effects.

The study, published in the journal Nature Chemical Biology, tested how nearly 14,000 compounds, hundreds of which were previously unexplored, affect basic cellular processes, to alert drug makers towards chemicals that are most likely to target a particular disease. The data pointed to ~1000 chemicals, many of which are natural products derived from soil microbes, as a rich source of potential medicines against a many diseases, including infections, Alzheimer's and cancer.

Despite modern technology, drug discovery still largely rests on guesswork. To find a drug that, say, kills cancer cells, scientists sift through libraries containing thousands of chemical compounds, the majority of which will have no effect at all.

Yeasts are currently the only living organism in which scientists have a good handle on the basic cellular processes, such as DNA replication and repair, energy production, and transport of cargo molecules, allowing them to link a drug to a particular bioprocess. Because natural compounds were shaped by evolution to act on living organisms, they are better candidates for future medicines than synthetic compounds that often do not even get into the cells.

For further details see:

Jeff S Piotrowski, Sheena C Li, Raamesh Deshpande, Scott W Simpkins, Justin Nelson, Yoko Yashiroda, Jacqueline M Barber, Hamid Safizadeh, Erin Wilson, Hiroki Okada, Abraham A Gebre, Karen Kubo, Nikko P Torres, Marissa A LeBlanc, Kerry Andrusiak, Reika Okamoto, Mami Yoshimura, Eva DeRango-Adem, Jolanda van Leeuwen, Katsuhiko Shirahige, Anastasia Baryshnikova, Grant W Brown, Hiroyuki Hirano, Michael Costanzo, Brenda Andrews, Yoshikazu Ohya, Hiroyuki Osada, Minoru Yoshida, Chad L Myers, Charles Boone. Functional annotation of chemical libraries across diverse biological processesNature Chemical Biology, 2017; DOI: 10.1038/nchembio.2436

Posted by Dr. Tim Sandle

Friday 22 September 2017

Key Factors for Producing Error Free Pharma Packaging


The pharmaceutical industry stands for one of the fastest growing and the most profitable industries in the world. An increase in sales and growth of the work amount, apart from the high profit, can bring some unwanted problems and challenges for the pharmaceutical manufacturers when it comes to packaging.

This is a guest post by John Alex.
Although in the last several years we have witnessed a great revolution of automation tools for packaging quality control, a great number of manufacturers are still not up to the task with the technological advancements which can help with packaging issues.

Specifics of the pharmaceutical industry

The pharmaceutical industry represents one of the most demanding industries in the world and as such has a developed set of packaging quality control rules and regulations under the authority of FDA.

The specific regulations relate to a whole range of necessary activities in the production, research, creation of the products, product protection, and market placement.

Because of the global nature of the pharmaceutical industry, companies have to deal with different regulations worldwide which have the consequence that companies need to be adept in interpreting the different requirements of local regulations.

Such a variety of numerous and special legal regulations are the culprit factor of production and packaging mistakes.

Pharmaceutical manufacturers on the global market are often under pressure to deliver safer superior packaging, more effective medications affordable in less time and at a lower cost.

“Markets and Markets” are estimating that the global pharmaceutical market will grow at a CAGR of 6.7% from 2013 to 2018, reaching a value of $78,8 billion.

This value includes medications delivery systems that are also considered to be product packaging. This sector of the packaging market is growing at an even faster CAGR of 9.1% due to increasing demand for delivery/packaging solutions as many medications come off-patent in the coming years. (1) The Rx medicine packaging and OTC medicine packaging

There are two types of products in the pharmaceutical industry that significantly determine a packaging process approach.

First are the medicines that are only given through physician prescription, so-called Rx medicines. The second are medicines that can be purchased in retail, so-called over the counter ie. OTC medication.

For a long time, Rx medicines products were not given much artwork packaging importance because these medicines are intended for a very narrow circle of professionals- pharmacist and doctors. Because of that, the packaging artwork of Rx products has been focused solely on the basic elements necessary for correct use of medical products.

This lack of packaging attractiveness, of course, does not exclude the importance of up-to-date and accurate information on the medication package. This includes information about ingredients, dosage, and mode of application.

A medication package should not be similar to any other form of packaging in order to avoid confusion with other types of products.

There is a general rule that non-pharmaceutical products should not be packed in packaging which resembles a blister pack (e.g. chewing gum) so that children do not get used to opening such packaging, which could endanger their safety.

The appearance of OTC medications is nowadays approached as a form of promotion by which the pharmaceutical industry has finally reached a mass media access point in advertising, thus more direct access to consumers without the intermediary of doctors.

The packaging of these products allows much greater freedom for creativity in creating attractive product packaging. But, this also leaves plenty of room for errors usually caused by human factor. That often leads to complete products recalls, which represents the worst-case scenario for the manufacturers.

According to Esko's market research, it is estimated that more than 50% of product recalls are related to the labeling or packaging artwork, and more than 60% of recalls are caused by human error. (2)

Factors determining the attractiveness of packaging include imaginative and innovative packaging artwork.

Since quality should not suffer due to packaging design, it is equally important to ensure that the product keeps its credibility as well as providing the sense of responsibility and security, to inform the consumer of the benefits of using the product and to provide the information on proper use and warnings in case of improper use.

Besides protecting the product from external influences, the packaging must make it easier to consume products, protect products, and prevent abuse while ensuring the entire process of delivering the product to the end user.

Smart and intelligent packaging labels as a response to the demanding modern market

Lately, there is an increasing demand for smart and intelligent packaging labels, with the goal of maximum product protection and achieving clearer communication with the consumers.

As smart packaging labels, we consider the packaging labels which contain the crucial data, information, and solutions regarding the product process, distribution, and sales.

A newer technology advancement is the use of packaging labels that observe temperature oscillations, possible growth of microorganisms, labels that have moisture-absorbing properties, indicators that show products freshness, light protection etc.

The greatest thing about smart packaging labels is the fact they can serve as a means for feedback from the product consumers themselves which manufacturers can find very [1] [2] useful.

Packaging against counterfeiting

The pharmaceutical industry permanently continues to face challenges with an increased number of counterfeit medicines and medical products.

One of the reasons for this is certainly high medication prices but also an opportunity for the black market to take up the part of pharmaceutical “market cake”. The challenge of protecting pharmaceuticals from counterfeiting continues to be one of the greatest issues in less developed countries.

The pharmaceutical industry is very sensitive to any kind of counterfeiting and misuse of the product. This is because every counterfeiting means a direct threat to the health and life of consumers. The riskiest group being children and elderly.

Taking into account the fact that as many as 10% of the worldwide medicines are falsified, it is easy to conclude why the pharmaceutical industry invests so much effort and money into the contemporary forms of protecting its products.

One of the possible ways to combat medicines counterfeit is packaging with protective elements. Among these elements is Braille text. Most legitimate pharmaceutical manufacturers take care of special user categories, so most of the pharmaceutical packaging also contains Braille.
Implementation of Braille to the medication product packaging is a sensitive and technically demanding process. Important information has to translate to Braille clearly and accurately.

Braille text itself, is not a great protection. But, its presence on the packaging in combination with other protection elements makes it much more difficult to counterfeit the original medication's packaging.

Another way of counterfeit protection is the amendment to the Falsified Medicines Directive (FMD), among which are serialization and the tamper seal.

Manual VS Automation packaging process

The use of automation technology for both, primary and secondary pharmaceutical packaging can help manufacturers save time, minimise errors, reduce costs and ensure an aseptic manufacturing process.

Primary packaging includes aseptic fill-finish and capping equipment, non-aseptic fill-finishing and capping equipment, unit dose fill-seal, blow/fill/seal, inspection systems, containment solutions, and product assembly lines.

Secondary packaging includes cartooning equipment, overwrappers and stretches banners, bulk packaging equipment, check weighers, serialization equipment, tamper-evident solutions and end packaging. (3)

It is evident that such a complex manufacturing process requires strict and efficient control in order to protect consumers themselves as well as manufacturers.

Since packaging of pharmaceuticals often contains small and complex details, much of the product information is often printed in small dots, barcodes, and graphics.

Because of its technical nature, manual inspection of these products is highly inadvisable, so packaging printing inspection automation technology should be introduced into the production process.

A good packaging quality control software platform should adhere to the rules and regulations of the pharmaceutical quality control standards.

Beside the individual packaging quality control segments which can be automated - Braille text, spelling, artwork label, text inspection, data integrity, pixel proof, graphics inspection, packaging print, discount, quality control inspection, preprint and print; it is possible to integrate an all in one quality control platform into the workflow and producing process.(4)

A packaging quality control platform which offers an all in one solution and is also integrable with other systems and hardware encompasses most pharmaceutical packaging challenges and provides the best value of ROI which is also an important business segment and goal of every manufacturer.

References:

1.(Markets and Markets. Pharmaceutical packaging market by packaging type (plastic bottles, blister packs, caps & closures, ampoules, vials and others) raw material (plastics, paper & paperboard, glass, aluminum foils), and drug delivery type–global trends & forecast to 2018.

http://www.marketsandmarkets.com/Market-Reports/pharmaceutical-packaging-market-890.html.

2. Philippe Adam, Global Marketing, Esko Best Practices:- How to Avoid the Five Common Pharma Packaging and Labelling Artwork Hurdles

http://www.pharmtech.com/best-practices-how-avoid-five-common-pharma-packaging-and-labelling-artwork-hurdles

3. KshitiJ (TJ) Ladage, Market Research Manager, Nice Insight, Nice Insight Pharmaceutical Equipment 2016 Annual Study

https://www.pharmasalmanac.com/articles/q2-ni-nice-insight-pharmaceutical-equipment-2016-annual-study

4. Mike Spooner, Integrating Quality Control Tools Into Print Workflow Automation Solutions

http://www.globalvisioninc.com/blog/saas/integrating-qc-tools-into-print-workflow-automation-solutions/

Author Bio: John Alex is a freelance writer, experienced blogger, and a professional social media coach. Currently, He’s working with globalvisioninc.com. Furthermore, John assists in the business creation and control social media content planning.

Tuesday 19 September 2017

GLP Inspections metrics reflections


An MHRA blog post by Martin Reed looks at collation of the 2015 inspection metrics data.

According to Reed, these data have "highlighted some common themes which I am going to illustrate by sharing some examples with you. All of the situations below have been observed within the past 12 months and have resulted in deficiencies (some major) being raised. The aim of sharing these examples is for organisations to identify if these issues could occur at their own facilities and allow them to pro-actively improve compliance."

The report can be accessed here: MHRA



Posted by Dr. Tim Sandle

Wednesday 13 September 2017

World Sepsis Day



Today is World Sepsis Day.

Here are some key points from World Sepsis Day 2017

What is sepsis?
Sepsis is a life-threatening condition that occurs when the body's response to an infection damages its own tissues and organs. Instead of local inflammation resulting from a local infection, which would be the appropriate response, the body’s entire system goes into inflammation. That’s sepsis. It is the leading cause of death from infection around the world, despite advances in modern medicine like vaccines, antibiotics, and acute care. Millions of people around the world die of sepsis every year.

How can this “inflammation” result in death?
This inflammatory response can lead to dehydration and changes in circulation, for instance a drop in blood pressure. This can compromise the ability of the circulatory system to provide adequately oxygen etc. to the tissues. That leads to dysfunction in various organs, such as the lung, heart, kidney, and brain. It can also lead to shock, multiple organ failure, and death, especially if it is not recognized early and treated promptly. Sepsis is an emergency.

How do I know it is sepsis?
Usually the first symptoms are those associated with the source of infection, such as a cough due to pneumonia or abdominal pain from appendicitis. Fever, a high pulse rate, and accelerated breathing are also signs. Everyone should be aware of the main clinical symptoms that indicate the worsening of an infection. Shortness of breath, reduction in urine output, dizziness, or altered mental status with confusion, agitation, or drowsiness can be signs of organ dysfunctions. In laboratory tests, sepsis often coincides with high white blood cell counts. But in the highly acute phase, and especially in immunocompromised patients, there may also be a decrease in white blood cell counts. In most cases, indicators of inflammation are increased.

Can sepsis be treated successfully?
Yes. The first hours of treatment are the most important. Patients must receive appropriate antibiotic therapy as soon as possible. Blood cultures and cultures from the site of infection under suspicion should be taken to detect the cause. Patients should also have their blood lactate levels measured, as this is a sign of dysfunction in the circulatory system. Patients with severe signs, such as hypotension and elevated lactate levels, should also receive fluids. Depending on the severity of organ dysfunction, they may require treatment in an intensive care unit.
If the sepsis has been caused by an infected foreign object in the body, a stone in the renal pelvis, or a ruptured intestine, then antibiotics alone are not enough. In these cases the focus of the sepsis or the foreign object needs to be removed surgically.

Is it normal to feel continually exhausted after having sepsis? Will I recover the energy I had before?
Fatigue after any serious illness, including sepsis, is very common. Your body has gone through a tremendous ordeal; it not only battled an infection, but it also dealt with sepsis, which could have resulted in death. Now that your body has successfully recovered from the immediate danger of sepsis, you need to rest, begin to regain your strength, and rebuild your body’s reserves.
If you continue to be exhausted, there may be other issues going on. You may want to consider a check-up with your doctor or nurse to be sure that other parts of your body, such as your thyroid, are functioning properly. You can also help rebuild your energy and strength by eating a healthy, balanced diet and getting enough physical exercise. Exercising when you are already tired may not seem easy, but if you start slowly, such as with regular walks around the neighborhood, you should be able to build up your energy. Also, check if there are any health rehabilitation programs available to you. In these programs, qualified personnel help you with simple exercise programs and monitor your progress over time.
Many people have cognitive problems like memory loss, inability to concentrate, and difficulty performing mental tasks that used to be easy before sepsis. It seems that the older you are when you get sepsis, the higher the risk of memory problems afterwards.

Can I prevent sepsis?
Preventing infections is the best way to prevent sepsis. Although there are no specific vaccines to prevent sepsis, vaccines are available for certain sepsis pathogens, such as pneumococci. Especially small children, people over 65, and patients who have no spleen should get vaccinated – they are particularly susceptible to pneumococci. This includes people who were born without a spleen as well as people who lost theirs due to an injury, surgery, or aggressive chemotherapy. You can also help prevent infection by maintain a healthy lifestyle with nutritious food, exercise, and rest. Wash your hands frequently. Seek medical help if an illness does not seem to be improving or is getting worse. Do what you can to prevent hospital-acquired infections. If you do get an infection, you can prevent sepsis by treating it seriously.
This means:
• Taking antibiotics as prescribed
• Finishing the entire course of antibiotics
• Don’t take antibiotics needlessly; this helps reduce the chances of developing antibiotic-resistant infections
• Don’t take someone else’s antibiotics
As healthcare professional you can help to reduce hospital acquired infections by following the patient safety program of the WHO.

Are there any specific risk factors that increase a person's likelihood of developing sepsis?
Anyone can get sepsis, even someone who was previously healthy. However, people with diabetes, cancer, HIV infection, previous chemotherapy, as well as corticosteroids users or those with any form of immunosuppression are more susceptible to severe forms of infection. Especially premature infants, small children, people 65 and older, and people with no spleen are more at risk. That risk can be reduced with a vaccination against pneumococci.

Can small wounds lead to sepsis?
If they develop from a local infection to a systematic inflammation, they are a source of sepsis.
We have seen sepsis cases triggered by small cracks at the corner of the mouth, which enable bacteria from the skin to spread into the circulatory system in children and adults.

Why have I never heard of sepsis before?
Sepsis isn’t talked about very often. We hear of people dying of infections. Often it was sepsis. Even today, if someone dies of sepsis due to pneumonia, (infection of the lungs) the cause of death is listed as pneumonia. If someone dies of sepsis after being severely burned, the cause of death is complications due to burns. Because sepsis is seldom listed as the cause of death, many people think it isn’t a problem. That is one of our biggest concerns. Increasing awareness of sepsis is one of our major goals.

Posted by Dr. Tim Sandle

Tuesday 12 September 2017

Regulators raise concern with rapid method validation


In July 2017 Sage Products Inc. received a warning letter from the U.S. Food and Drug Administration (FDA). Within the warning letter was a concern about the implementation of rapid microbiological method, where the method had been used to replace a compendial method.

In the warning letter, the FDA state “Your firm failed to establish and document the accuracy, sensitivity, specificity, and reproducibility of its test methods.” This relates to the use of a rapid method.

Specifically: “You use the (b)(4) method to screen for microbiological contamination in drugs produced entirely at your facility and those manufactured under contract. This (b)(4) screening method (b)(4) for microbiological examination of your liquid drug products is not adequate for its intended use. You attempted to validate your (b)(4) microbial detection method, but were not able to demonstrate that it could reliably and repeatedly determine whether objectionable microorganisms were present in your drugs.”

The FDA are concerned about the comparative findings from the USP method and the replacement rapid method: “After receiving three consumer complaints for discoloration of this product, you initiated testing of your retains using both the modified U.S. Pharmacopeia (USP) microbiological limits method and the (b)(4) method. Both analyses found microbial contamination. Notably, the USP modified method (b)(4) found an exceedingly high microbial count of over 57,000 CFU/ml, and also identified Burkholderia cepacia, an objectionable microorganism, in this product lot.”

It seems that the firm elected to run with the results from the alternative method, despite the USP method finding an objectionable microorganism. This led the FDA to state: “Had your firm been utilizing a screening method capable of consistently detecting B. cepacia, these products may not have been released in the first instance.” Part of the reason was “because [the company] failed to include B. cepacia on the list of objectionable organisms.”

The use of the alternative method had also gone against FDA advice: “FDA informed you that your (b)(4) method (b)(4) has not been adequately validated for detecting the presence of microorganisms, including the presence of B. cepacia. In a subsequent meeting on November 30, 2016, FDA advised you to use a verified compendial method for all bulk drug solutions and finished product microbiological testing until you could further assess the suitability of the (b)(4) method.”

The concerns the FDA had with the rapid method were:

“It specifies a (b)(4) dilution factor. USP <62> requires a 1:10 dilution factor. Your dilution factor is (b)(4) times greater than the USP method and provides insufficient detectability to rule out the presence of objectionable microorganisms and unacceptable total counts.”

Furthermore the rapid method it not account for the enrichment step called for in USP <62>. Also “it does not include the scraping step during sample preparation, which your submitted laboratory data indicates is required to validate organism recovery.”

There was also a comment about the use of stressed organism as part of method validation (a controversial point within pharmaceutical microbiology): “it lacks evidence that small numbers of various microorganisms, including those that are injured and stressed, can be reliably recovered. Specifically, sample effect (defined by your firm as the inhibitory effect of a sample on the growth of various microorganisms) data for B. cepacia was collected using a fresh-grown culture, not a stressed organism.”

The final charge was that the method validation did not “establish potential sample interference factors (e.g., enhancing or quenching) for each product formulation.”

There was also criticism about the sampling and sample plan used to ensure the tested sample was representative of the lot. There was also concern that the replacement method, unlike the USP method, did “not provide for potential speciation of the detected microbial contamination in the (b)(4) initial screening test.”


The implications from the FDA letter, as well as signaling a pertinent lesson when implementing a rapid method that needs to be equivalence to or better than the rapid method, are:
  • Does the validation of methods require the use “stressed” organisms?
  • Does validation always need to be against each product formulation (not just the strongest concentration of the most inhibitory ingredient)?
  • How are representative samples built into the validation process?
  • Does a list of objectionable organisms need to be prepared ahead of the method validation? Or is this just a B cepacia issue?

If you have views on this, please add a comment.

Thanks to Nigel Halls for the heads-up about this warning letter and its considerable implications.



Posted by Dr. Tim Sandle

Sunday 10 September 2017

Battle-plan blueprints for attacking disease-causing bacteria


The scientists, led by Fellow Emeritus in Trinity's School of Biochemistry and Immunology, Professor Martin Caffrey, used next-gen X-ray crystallography techniques to 'look under the bacterial bonnet' and produce a molecular blueprint that may be used to design drugs that minimise off-target effects and attack any structural weaknesses.
The research, which shows that one key enzyme used in the common bacteria Pseudomonas aeruginosa and Escherichia coli is remarkably similar in structure in both species, has recently been published in leading international journal Nature Communications. These two bacteria opportunistically infect people, and can cause fatalities.
Professor Caffrey said: "The structural blueprints of the two bacteria -- while very similar -- differ in their fine detail. These subtle differences might be exploited to design species-specific therapies with a reduced likelihood for the development of antibiotic resistance."
Both Pseudomonas aeruginosa and Escherichia coli are medically important, causing problems in tens of thousands of patients every year. Both are known to have developed resistance to a plethora of first-choice drugs used to treat them. And with antimicrobial resistance on the rise in general, the World Health Organization has advised that a post-antibiotic era, in which minor injuries and common infections could prove fatal, is looming.
New drugs are badly needed. However, while the new blueprint of the bacterial enzyme 'Lnt' offers hope for drug development, the process of creating effective candidates is not an easy one. Firstly, similar enzymes are present in humans and other animals, so any drug would need to be sufficiently specific to only affect the bacterial enzyme. Secondly, the biological structure of any drugs that would bind to the bacterial enzymes and inhibit them is likely to be similar to the structure of molecules that inhibit the innate immune response. In other words, stopping the bacteria in its tracks may also slow the body's natural response to infection.


Speaking about the difficulty in designing 'silver-bullet' drugs that could turn the tide, and about the next steps in his team's work, Professor Caffrey added: "The structural blueprints generated as part of this study provide a basis whereby the differences between the bacterial enzyme and the immune response proteins might be exploited with the goal of producing a drug that only hits the bacterial target."

Posted by Dr. Tim Sandle

Thursday 7 September 2017

Products for Microbiological Control

Benefit from Sartorius’ long-standing expertise in microbiological quality control while increasing performance and enhancing your workflows. To help improve the safety of quality-critical processes, we offer premium products for microbial limit testing, sterility testing, air monitoring and Mycoplasma detection. Obtain reproducible, reliable results for in-process and final release testing to meet the industry’s requirements of today and anticipate the demands of tomorrow.

Tuesday 5 September 2017

Unknown virus discovered in 'throwaway' DNA


Finding new viruses has historically not been an easy process. Cells do not grow on their own, so must be cultured in a laboratory before they can be analysed, which involves months of work. But the Oxford research represents a massive opportunity for the future.

Next-Generation Sequencing has revolutionised genomics research and is currently used to study and understand genetic material. It allows scientists to gather vast amounts of data, from a single piece of DNA, which is then collated into huge, online, genome databases that are publicly accessible.

A chance discovery has opened up a new method of finding unknown viruses. Researchers have revealed that Next-Generation Sequencing and its associated online DNA databases could be used in the field of viral discovery. They have developed algorithms that detect DNA from viruses that happen to be in fish blood or tissue samples, and could be used to identify viruses in a range of different species.

See:

Amr Aswad, Aris Katzourakis. A novel viral lineage distantly related to herpesviruses discovered within fish genome sequence dataVirus Evolution, 2017; 3 (2) DOI: 10.1093/ve/vex016

Posted by Dr. Tim Sandle

Sunday 3 September 2017

Data-Driven Risk Management For Quality By Design


The main hope of ICH Q8-Q10 pertaining to operational excellence is to enable (bio)pharmaceutical companies to achieve product realization. The goal is to do so by establishing and maintaining a state of control and facilitating continual improvement while responding to pressures for efficiency and profitability improvements.

Peiyi Ko, Ph.D. and Peter Calcott, Ph.D. have written an interesting article on the subject for Pharmaceutical Online. Here is an extract:

“risk management is open to individual interpretations and at times has varied and been time-consuming and not-informative for prioritization, re-inventing risk assessments and leading to wasted resources and unsatisfactory outcomes. Therefore, it is proposed to use a quantitative approach with probabilistic calculations and monetized harm to account for occurrence and severity, respectively. Specifically, failure modes and effects analysis (FMEA) is a classic tool for summarizing the modes of failure, factors causing these failures, and the likely effects of theses failures to reduce process complexity for management. It generates a risk priority score for a failure mode by multiplying the ratings for severity, occurrence, and detection.”

To access the article, see Pharmaceutical Online.

Posted by Dr. Tim Sandle

Friday 1 September 2017

Yeast helps hunt for new medicines


Scientists have developed a new way to predict potentially useful drugs from a pool of undefined chemicals. They were able to more quickly identify leads that could be used to treat a range of diseases, from infections, to cancer to Alzheimer's. The finding will also help better match drugs to a disease to maximize the benefit and reduce side-effects.

The study, published in the journal Nature Chemical Biology, tested how nearly 14,000 compounds, hundreds of which were previously unexplored, affect basic cellular processes, to alert drug makers towards chemicals that are most likely to target a particular disease. The data pointed to ~1000 chemicals, many of which are natural products derived from soil microbes, as a rich source of potential medicines against a many diseases, including infections, Alzheimer's and cancer.

Despite modern technology, drug discovery still largely rests on guesswork. To find a drug that, say, kills cancer cells, scientists sift through libraries containing thousands of chemical compounds, the majority of which will have no effect at all.

Yeasts are currently the only living organism in which scientists have a good handle on the basic cellular processes, such as DNA replication and repair, energy production, and transport of cargo molecules, allowing them to link a drug to a particular bioprocess. Because natural compounds were shaped by evolution to act on living organisms, they are better candidates for future medicines than synthetic compounds that often do not even get into the cells.

For further details see:

Jeff S Piotrowski, Sheena C Li, Raamesh Deshpande, Scott W Simpkins, Justin Nelson, Yoko Yashiroda, Jacqueline M Barber, Hamid Safizadeh, Erin Wilson, Hiroki Okada, Abraham A Gebre, Karen Kubo, Nikko P Torres, Marissa A LeBlanc, Kerry Andrusiak, Reika Okamoto, Mami Yoshimura, Eva DeRango-Adem, Jolanda van Leeuwen, Katsuhiko Shirahige, Anastasia Baryshnikova, Grant W Brown, Hiroyuki Hirano, Michael Costanzo, Brenda Andrews, Yoshikazu Ohya, Hiroyuki Osada, Minoru Yoshida, Chad L Myers, Charles Boone. Functional annotation of chemical libraries across diverse biological processesNature Chemical Biology, 2017; DOI: 10.1038/nchembio.2436

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