Thursday 28 September 2023

Pharmaceutical giants wager on AI to expedite clinical trials

 

Major pharmaceutical companies are employing artificial intelligence to speed up the process of finding participants for clinical trials and potentially save millions of dollars by reducing the number of individuals required to test drugs.

Businesses like Amgen, Bayer, and Novartis are teaching AI to search through billions of public health records, prescription data, medical insurance claims, and internal data to discover trial patients, sometimes cutting the time it takes to sign them up in half.



 

The U.S. Food and medication Administration (FDA) reported that from 2016 to 2022, it had received around 300 applications involving the use of AI or machine learning in medication development. More than 90% of those applications were submitted in the last two years, and the majority involved using AI at some stage of clinical development.

Source: https://www.reuters.com/technology/big-pharma-bets-ai-speed-up-clinical-trials-2023-09-22/ 

 

Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

Wednesday 27 September 2023

New partnership seeks to reduce toxic effects of pathogenic digestive bacteria


 

 

The bacterium Clostridioides difficile is a nosocomial infectious agent and one that is challenging to treat. C. difficile infection is spread by bacterial spores found within faeces. Transmission occurs if surfaces become contaminated with the spores with further spread occurring via the hands of healthcare workers.

 

 

 

Mohamed Seleem, director of the Center for One Health Research, and the company Nectagen Inc,. have received a $275,000 grant from the U.S. National Institute of Allergy and Infectious Diseases. The funds will be used to study whether synthetic proteins developed by Nectagen can reduce the toxicity of the digestive bacteria.

 

The widespread use of antibiotics for a variety of medical issues can destroy beneficial intestinal biomes along with harmful infectious bacteria. The use of systemic antibiotics, including broad-spectrum penicillins/cephalosporins, fluoroquinolones, and clindamycin, causes the normal microbiota of the bowel to be altered.

 

This can open the door for spores of C. difficile to vegetate and dominate the digestive system, becoming a dangerous pathogen that can lead to life-threatening bouts of intestinal cramps and diarrhoea.

 

Other risk factors involved in the causation of infection include advanced age, chemotherapy, use of proton pump inhibitors, chronic renal disease, chronic liver disease, and malnutrition.

Only one new antibiotic drug has been developed to fight C. difficile in the past 40 years. Some patients are treated with an antitoxin, but it must be taken intravenously and is often prohibitively expensive. Currently, restoring the gut microflora through methods such as fecal microbiota transplantation is one of the most effective approaches for the treatment of an infection.

 

C. difficile recurs in up to 20 percent of patients after treatment, and many of those patients die. A more effective, less expensive, orally consumable approach is needed to reduce mortality from C. difficile.

 

The grant funding will enable the Seleem Lab in the Center for One Health Research — a collaborative effort of the Virginia-Maryland College of Veterinary Medicine and the Edward Via College of Osteopathic Medicine — to conduct testing on animal models to determine if synthetic “nanoCLAMP” proteins produced by Nectagen, ingested orally, can reduce the toxic effects of C. difficile.

 

The term nanoCLAMP contains the prefix “nano”, implying microscopic size; while CLAMP stands for CLostridal Antibody Mimetic Proteins. This refers to specialized molecules designed to bind to specific molecular targets within cells.

 

Nectagen is a Lawrence, Kansas-based biotechnology company that develops and markets “antibody mimetic reagents,” or lab-created molecules that behave similarly to an antibody by imitating an antibody’s binding properties.

 

It is hoped that the nanoCLAMP proteins will be “thermally stable and protease resistant” enough to survive in the digestive tract and protect endothelial cells lining the intestines from C. difficile toxin damage.



Read more: https://www.digitaljournal.com/tech-science/new-partnership-seeks-to-reduce-toxic-effects-of-pathogenic-digestive-bacteria/article#ixzz8A0yhWkHD

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

Tuesday 26 September 2023

The Benefits of Cryotherapy


 

Are you looking for a revolutionary way to boost your overall health and well-being? If so, then you may be interested in learning about the incredible benefits of cryotherapy. Cryotherapy is a treatment that involves exposing your body to severe cold temperatures for a short period of time. This method has been gaining popularity in recent years due to its many health benefits. This blog post will explore some of the top benefits of cryotherapy and how it can improve your life.


By Lizzie Weakley


Reduces Pain and Inflammation

Cryotherapy reduces pain and inflammation by constricting your blood vessels and reducing the flow of blood to the affected area. This treatment can be especially beneficial for individuals suffering from chronic pain, such as arthritis or fibromyalgia. It can also be helpful for athletes looking to reduce muscle soreness and speed up recovery after a workout.

 

Boosts Energy and Enhances Mood

Cryotherapy has been shown to boost energy levels and enhance mood by increasing the release of endorphins, the body's natural painkillers. This treatment can also help to reduce stress and anxiety, which can have a positive impact on mental health. By improving your mood and energy levels, cryotherapy can help you lead a more productive and fulfilling life.

 

Enhances Athletic Performance

Whole body cryotherapy sessions can enhance athletic performance by reducing muscle soreness and inflammation, which can improve mobility and range of motion. This treatment can also increase blood flow and oxygenation to muscles, which can enhance endurance and speed. Many professional athletes use cryotherapy regularly as a means of improving their performance and preventing injuries.

 

Helps with Weight Loss

 

Cryotherapy has been shown to help with weight loss by increasing the body's metabolic rate. This treatment can also help to reduce the appearance of cellulite by stimulating the production of collagen in the skin. By incorporating cryotherapy into your weight loss plan, you may be able to achieve your goals more quickly and effectively.

 

Strengthens the Immune System

Cryotherapy can strengthen the immune system by increasing the production of white blood cells, which help the body fight off infections and diseases. This treatment can also help to reduce inflammation, which is a primary cause of many chronic illnesses. By strengthening your immune system, cryotherapy can help you stay healthy and avoid getting sick.

 

Cryotherapy is a revolutionary treatment that can have many positive effects on your overall health and well-being. Whether you are an athlete looking to enhance your performance, or someone looking to boost your mood and energy levels, cryotherapy may be able to help. Before trying cryotherapy, be sure to consult with a healthcare professional and find a reputable provider in your area. Try it today and experience first-hand the incredible benefits of this cutting-edge treatment.

 

Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

Monday 25 September 2023

What Counts? Establishing a Bioburden Strategy for a New Pharmaceutical Product


 

For both sterile and non-sterile manufacturing, bioburden control as evidenced by microbial counts is especially important in relation to the quality of the finished product and as an indicator of process control. Samples are drawn from intermediate product at defined stages (ideally based on risk assessment) and these allow for the microbial levels to be tracked from upstream processing to downstream processing (with an expectation that the microbial levels decrease, or at least remain unchanged provided they are below an acceptable action level).

 

 

Sandle, T. (2022) What Counts? Establishing a Bioburden Strategy for a New Pharmaceutical Product, American Pharmaceutical Review, 25 (6): 62-67

 

See: https://www.americanpharmaceuticalreview.com/Featured-Articles/590786-What-Counts-Establishing-a-Bioburden-Strategy-for-a-New-Pharmaceutical-Product/

 

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

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