Pharmaceutical Microbiology Resources. Edited by Professor Tim Sandle (established 2009)
The EMA has updated this Q&A relating to key GMP and GDP topics. Updates relate to two questions, which are questions 2 and 5:
EU GMP Guide Part 1 CH 5 Q2
This indicates that it is possible to use multiple batch numbers in packaging of medicinal products
Q5 relates to the requirements for batch numbers appearing on the packaging of medicinal products subject to parallel trade.
Image Source: Pixabay
A guest post by Indiana Lee
Neurodegenerative diseases have baffled and frustrated researchers and clinicians alike for decades. Despite prodigious advances in medical and biological science, Alzheimer’s Disease and related dementias have defied the experts’ staunchest efforts to understand the etiology of the disease or to intervene in its progression.
And that has meant that, for far too long, there had been devastatingly few options for victims, families, and healthcare providers. For too many years, patients, families, clinicians, and researchers had been largely powerless in the face of the mysterious and merciless adversary.
But that is changing. Every day, our understanding of progressive dementias grows. At any given moment, new and better diagnostic strategies are emerging. Now more than ever, we have an array of treatment options to slow the cognitive decline — and countless more are currently under development.
And that means that, though Alzheimer’s remains a fearsome nemesis, there is hope on the horizon, with an army of researchers leading the way.
Among the most exciting domains of Alzheimer’s research, today is in the field of microbiology. A growing body of research is supporting, and describing, the microbial mechanisms at work in the brains of patients with Alzheimer’s and other dementias.
Of particular interest is the role of gut bacteria in the progression of neurodegenerative diseases. According to recent research from the Human Microbiology Institute, bacteriophages, which are viruses that invade and replicate inside bacteria, appear to be implicated in the etiology of Alzheimer’s and related diseases.
These findings also seem to align with studies that have found that specific soy metabolites created by certain types of gut bacteria are strongly associated with fewer white matter lesions in the aging human brain. It is possible, therefore, that in the future, clinicians may be able to evaluate patients’ gut biome to assess their level of disease risk and perhaps even to intervene through dietary or pharmaceutical means.
However, it’s not only gut bacteria that seem to play a role. Research suggests that oral bacteria are also likely to contribute to neurodegenerative disorders, especially in those with a genetic predisposition to such diseases. Bacteria associated with gum disease, for example, are strongly associated with increased levels of inflammation, which can be damaging to the brain’s vascular system and may also contribute to the formation of plaques in the brain. Additionally, these oral bacteria are also highly likely to infiltrate the brain via the mouth’s circulatory system.
This enhanced understanding of the complex etiology of Alzheimer’s and related dementias is, of course, fundamental to our efforts to mitigate risk factors and prevent or delay the onset of disease. For example, maintaining excellent oral health can be an important tool for avoiding pathological cognitive decline. Good, consistent oral care and the early treatment of periodontal disease, studies suggest, are especially important to the formation and proliferation of bacteria that can damage the brain.
Gene therapy is also proving to hold immense promise both for prevention and for the treatment of these disorders. For example, activation of p38gamma has been shown to significantly improve enzymatic memory. This, some studies suggest, may not only slow disease progression but may even reverse even severe memory loss.
One of the greatest and most heartbreaking frustrations of neurodegenerative diseases like Alzheimer’s has been the appalling lack of effective treatment options for so many years. As our understanding of the origins and progression of these disorders grow, however, so too do the number of weapons in our arsenal.
In addition to gene therapies, managing the gut microbiome, and ensuring superb oral health, there are also a rapidly growing number of sophisticated and effective therapies. Most importantly, for the first time, emerging therapies are increasingly capable not only of treating disease symptoms but of slowing and mitigating disease evolution.
For example, therapies are being developed to prevent the formation of beta-amyloid plaques using a range of targeted therapies. These include the use of monoclonal antibodies to harness the power of the immune system to clear plaques from the brain, or the deployment of Fyn proteins to improve synaptic function.
In conjunction with the therapeutic approach, research is demonstrating the efficacy of a more holistic strategy. Lifestyle management that centers on the integration of diet, exercise, sleep, social interaction, and cognitive stimulation is highly effective in reducing symptoms and delaying disease progression.
Neurodegenerative diseases are among the most feared and tragic of human ailments. And what makes it even worse, perhaps, is that for far too long there had been precious little that anyone could do about it. There is, however, significant hope on the horizon. As our understanding of the etiology and progression of these dreaded diseases grow, so too does our ability to delay, prevent, mitigate, and even reverse their effects. And that means that there may well soon come a day when no family is forced to face this long goodbye.
Pharmaceutical product recalls relate to a type of flaw, ranging from mislabelling to contaminated ingredients. Generally, pharmaceutical companies conduct voluntary recalls in collaboration with a regulatory agency. This article looks at recent data for pharmaceutical recalls pertaining to the US and Europe, both as overall trends and in relation to specific occurrences. The assessment suggests that the rate of recalls is increasing.
Tim Sandle has written a new article: 
The types of pharmaceutical products that undergo a recall are as varied as the available products on the market. They include over-the-counter, prescription and compounded drugs, ranging from tablets and capsules, injectable drugs, liquids, lotions and creams, and many more. Similarly, the reason for recalls are equally varied although there is more commonality in terms of the general types of problems that trigger recalls to occur.
The leading causes of pharmaceutical recalls are sterility, the presence of particulate/foreign matter, and failed specification testing, according to figures from the US Office of Pharmaceutical Quality. Every recall is different, so the financial impact varies greatly. It is based on a number of factors, including the number of units affected and the global reach of the recall. There are also indirect costs that need to be factored in. For example, if pharmaceutical companies don’t work with partners to execute the recall, their internal staff must step in at the expense of their usual duties.
This article presents the main types of recalls occurring within the US, Europe and other territories, noticing some differences in trends and approaches to recalls.
For details, please contact Tim Sandle
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Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)
The connection between COVID-19 symptoms and other underlying health conditions continues to be researched. A new finding draws a connection between symptom severity and intestinal health, in relation to the gut microbiome.
As an example of one of the connections between COVID-19 symptom severity and an underlying health condition, it as been established that diabetes can make the disease worse. This is possibly because the coronavirus triggers inflammation in the body and high blood (glucose) sugar levels also cause inflammation inside our body, hence the action of the virus exacerbates the diabetic condition.
With the new strand of research, scientists have examined emerging evidence suggesting that poor gut health adversely affects COVID-19 prognosis. Central to this the microbiome and the variations between the microbial communities in the gut between individuals.
The human microbiome refers to the totality of microorganisms and their genetic interactions within a given niche. The human body is an intricate system that hosts trillions of microbial cells across the epithelial surface, and within the mouth and gut. These microorganisms play a role in human physiology and organ function, including digestion and immunity.
The research finds that intestinal dysfunction appears to exacerbate the severity of coronavirus infection. This is through enabling the virus to access the surface of the digestive tract and the internal organs. These organs are, in particular, vulnerable to infection because the cells have ACE2 on their surfaces, which is the protein target of the coronavirus.
In terms of the cause, the researchers consider diet to be an important determinant. Of concern is the so termed "western diet", which is characterized by a diet low in fiber. A fiber-deficient diet is one of the main causes of altered gut microbiomes.
The research has been published in the journal mBio, and it is titled "Do an Altered Gut Microbiota and an Associated Leaky Gut Affect COVID-19 Severity?"
