Tuesday 29 June 2021

Some forms of diet may increase levels of harmful bacteria in the gut


The type of diet adopted influences the make-up of the gut microbiome, according to a new study into the microbiota of the human gut. Scientists have demonstrated the extent that a very low calorie diet can alters the composition of the organisms present in the gut.


While there is a clear association with certain bacteria and disease within the human body, microbiome research remains cutting edge as scientists seek to figure out the myriad roles of bacteria in the body.


With the specific diet centric study, the Charité -- Universitätsmedizin Berlin research highlighted a specific risk factor whereby dieting was found to be associated with a rise in levels of the anaerobic bacterium Clostridioides difficile, an organism linked to diarrhea and colitis.


While C. difficile can become established in the human colon without causing disease, what is important is the balance of this organism relative to more benign species and the population dynamics should other organisms decrease in numbers.


The research looked at 80 post-menopausal women, classed as being slightly overweight to severely obese. The women were studied over the course of 16 weeks.


The women followed a medically supervised meal replacement regime of less than 800 calories a day or they eat what they chose and maintained their weight for the duration of the study. To assess microbiome fluctuations, stool sample analysis was performed.


The stool samples revealed that dieting reduced the variety of microorganisms present in the gut and generally lowered numbers. Furthermore, the bacteria present in the gut adapted their metabolism so they absorbed more sugar molecules.


For those dieting, the researchers recorded a rise in the colonization of C. difficile. This has an association with severe inflammation of the gut wall when the bacterial population is high. Moreover, C. difficile produces toxins which can be harmful.


Furthermore, the organism was found to sometimes prevent the absorption of nutrients into the gut wall suggesting a potential association with problems achieving the desired with loss and also with diabetes.


The data could be used for new advice when it comes to dieting. For example, the consumption of particular types of food could trigger shifts in existing host bacterial genera. These bacteria may have the ability to affect host immune and metabolic parameters.


It should be possible to counterbalance the effects seen in the study with more controlled diets. Evidence suggests that diet can modulate host-microbe interactions and this heralds a promising therapeutic approach.


The research appears in the science journal Nature, titled “Caloric restriction disrupts the microbiota and colonization resistance.”


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

Monday 28 June 2021

Three Times And We’re Alright? Replicates In Validation

Numbers are essential to validation, just as numbers are critical to much of human activity. Numbers represent the continuous variables that we use to describe the world. Numbers can be something directly observable, or they can be theoretical constructs, used as parameters within a model. While both play a part in ‘validation’, it is with the former that this article toys with. The issue at hand is with how much validation is required at the performance qualification stage for a given validation stage? This may be a cleaning cycle on a vessel or an autoclave load.

How many times should such validation exercises be conducted in order to show that the results are reliable? While the number of runs should rest with the outcome of a risk assessment, it is generally the rule that the number of runs is seldom less than three. This begs two questions: why is three considered acceptable?, and is three enough? Before entering this debate it is interesting to consider what is so special about the number 3. After this, this article looks at the issue from the process validation perspective and the analytical assay perspective, concluding that three runs or assays is rarely enough. Moreover, with process validation greater weight should be put onto the lifecycle approach for trending and hence understanding process performance.


To view see: ResearchGate

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

Sunday 27 June 2021

How Is Personalized Medicine Changing the Pharmaceutical Industry for the Better?

Article by Emily Newton

Bio: Emily Newton is the Editor-in-Chief at Revolutionized. She regularly covers stories in the tech and industrial sectors.

Most people can recall instances where they received prescription drugs that didn’t work as well as their physicians expected. Personalized — or precision — medicine aims to eliminate or substantially reduce such occasions with medications made for specific patients. Here’s a look at how that trend could bring about notable and positive pharmaceutical industry changes. 

Helping Clinical Trials Succeed More Often


Pharmaceutical companies invest significant amounts of time and money into products that often fail in clinical trials. One large study showed that less than 14% of drugs succeed in all clinical trial stages. However, variation occurs depending on the medication category. For example, products for oncology patients work only 3.4% of the time.


Precision medicine could reduce the likelihood of failure by giving more insights into how individual patients might react and which dosage regimens should provide the desired results. For example, looking at data that shows a patient’s metabolic profile could show their likely response to a medicine based on the presence of a particular gene. That knowledge could reverse side effects that may delay a clinical trial or mean a drug does not progress to the next phase.


Another possibility is to use genetic data to get clues about how specific population subgroups will likely respond to a product. This allows clinical trials to proceed more efficiently and effectively because the people taking the medication are highly likely to react favorably with fewer adverse effects. Thus, clinical trials become more adaptive, which could support patient and pharmaceutical company goals.  

Promoting Cost-Saving Measures


Pharmaceutical executives face the daunting task of keeping costs as low as possible while helping an organization’s bottom line. The industry typically faces higher expenses than some other sectors, but personalized medicine could help address that matter.


A survey of top pharmaceutical leaders showed that 92% considered precision medicine an opportunity, and 84% of respondents had placed it on their corporate agendas. Moreover, most of the people in the study believed precision medicine provided obvious drug development advantages over current methods. It would shorten research and development times and speed the time to market.


The research also noted that even a modest estimate indicated personalized medicine could lead to a 17% savings for drug development. In that case, the total cost reduction could total $26 billion annually for the worldwide industry.


Switching to a personalized medicine focus certainly takes substantial time, money and dedication. However, many pharmaceutical company leaders could find it worthwhile, especially as stakeholders become more interested in precision medicine during the foreseeable future. Making that decision could help businesses save money over the long term while remaining relevant in a competitive industry.

Offering More Access to Data


Data is at the heart of personalized medicine. It helps confirm how to create the most effective treatment for one person. It’s no surprise that some pharmaceutical companies invest in businesses to increase the overall information available to them.


For example, Roche recently struck several acquisition deals for companies that will result in access to genomic data from thousands of patients with cancer. That’s an example of how acquisitions could help companies get a head start after leaders show interest in personalized medicine.


Gaining insights from data is also becoming a more widespread practice even before company representatives actively pivot into personalized medicine. For example, many bioprocessing facilities transitioned into Industry 4.0 operations by using smart sensors to monitor procedures.


That works exceptionally well with temperature-sensitive processes. Experts widely agree that a temperature range between 30-35 degrees Celsius is ideal for bioethanol fermentation. Sensors can confirm those conditions and even send the information to a lab technician’s smartphone.

Moving to Better Operating and Production Methods


Personalized medicine represents one of many factors that have pushed pharmaceutical companies to change for the better over the years. Another example is the transition from batch chemistry to flow chemistry. The latter option involves chemical reactions occurring in a tube. It typically has a 10%-20% smaller space requirement than batch processing. Plus, it leads to quicker chemical reactions with improved yields.


One flow chemistry system used at Pfizer sampled 5,760 reactions in four days. Laboratory personnel then chose the ones with the best yields and scaled up based on that information. This approach is one example of how pharmaceutical company evolution could reduce trial-and-error methods, getting effective products on the market more efficiently.


Pharmaceutical companies that embrace precision medicine must implement wholly different manufacturing methods. However, as the flow chemistry example above shows, using new options could bring significant payoffs.


Chris Striffler, supply chain services leader at Clarkston Consulting, explains, “With precision medicines, it’s a much more complex model with more products, and with a lot size of one, it’s a complete shift away from large batch production.” He continued, “The clinics, hospitals and physicians’ offices are now a much more critical part of the supply chain.” That shift could make pharmaceutical companies more aware of areas for growth and how to better serve customers.


Enabling Rapid Therapeutic Treatments


The discussion above highlighted how personalized medicine could enhance clinical trials and improve patient outcomes. However, a similar effect could happen if pharmaceutical companies get ongoing, real-time data from individualized patients.


A team of scientists recently developed an approach that speedily detects target molecules. It relies on supramolecular compounds serving as hosts. Once it recognizes a target, the two molecules bind and cause fluorescence, making the molecule’s presence known.


Getting data about a patient’s blood molecules is a vital part of accelerating personalized medicine, particularly for determining the therapeutic dosage. For now, drug manufacturers rely on averages for suggested dosages. However, that typically means the data relates to male test cases. Various other factors, such as a person’s age and weight, can affect how they metabolize a drug, too.


This recent progress in finding target molecules could help pharmaceutical companies move away from averages toward service to single patients. Plus, it could mean businesses more quickly determine the correct dosage for people in life-threatening situations.

Personalized Medicine Is the Future


People are increasingly getting more interested in precision medicine. They know it often doesn’t make sense to give someone the same medications or dosages intended for thousands or millions of other patients.


It will undoubtedly take time for pharmaceutical companies to transition to a personalized medicine approach. However, this overview shows that the decision can bring plenty of positive impacts, helping them remain competitive now and over time.

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