Michigan State University

DUBLIN--( BUSINESS WIRE )--The "Aseptic Processing of Pharmaceutical and Biotech Products Course" training has been added to ResearchAndMarkets.com's offering. This comprehensive course covers fundamental principles, advanced techniques, and regulatory insights necessary for success in aseptic processing. Explore the critical practices and regulatory requirements essential for maintaining sterility and ensuring product quality in pharmaceutical and biotech manufacturing. To adhere to this demand and raise the benchmark of aseptic manufacturing, we have curated a 2-day long virtual course for esteemed professionals like you. Thus, if you are associated with any department of biological and pharmaceutical manufacturing, this course will upskill your knowledge about every step. This course equips you with the knowledge to evaluate the risks and failures in the unit. Moreover, you will be able to identify the repetitive penalties being imposed on the organization due to disappointing manufacturing practices. By the end of this seminar, your products will be ready to pass sterility tests and FDA audits without any hiccups. Course Overview While current GMPs are detailed enough to meet FDA guidelines, many manufacturing units suffer production delays, product losses, and health risks. What is the point of working with high-end facilities and setups when you are still facing common issues? To tackle these, World Compliance Seminar has curated a course to guide you about handling manufacturing facilities effectively. The core benefits of the aseptic processing course include: Managing the complexity of working with highly potent ingredients and executing fill-finish effectively Identifying and overcoming issues with single-use system Exploring the latest technologies available in aseptic filling Best practices to eliminate contamination risk through barrier technology Deeper insights from regulatory panels across the leading countries in the world Understanding the role of robotics in aseptic processing Examining strong trends in small-scale and ready-to-use products Who Should Attend: Aseptic sterile technique training will benefit plenty of individuals such as: Manufacturing professionals: Get the right knowledge of basic principles and develop skills to control procedure setting Project Manager: Understand critical factors required to maintain compliance Quality Control Professionals: Decrease the inspections failures, cautionary letters, and agreement rulings Reformulation and Formulation Developer: Determine how to develop media fill simulations and work on the worst-case scenarios Process Chemistry Specialists: Learn the best repetition techniques for decisive media fill sizes Apart from these professionals, the course is also useful for analytical chemists, in-house regulatory compliance officials, scale-up and technology transfer professionals, and validation experts. Key Topics Covered: Aseptic Processing - Introduction The Disinfected Quantity Form Conservation and control of serious surroundings Expansion of procedures for process, standardization, Preventive Maintenance, CAPA, etc. Exercise of workers to include gowning Certification and assessment of variations Adulteration Sources in Sterile Manufacturing Subdivision Content Controls Cross Pollution Hazards Cleaning Process and Agents for Sterile Production Developing Media Fill Requirements in An Aseptic Environment Form FDA 483s Equipment set up Sterilization process Media fills Smoke studies and their emphasis in Aseptic Production (ISO Class 5 facilities) Endotoxin sources Speakers: Barry A. Friedman, Ph.D Consultant Cambrex Bio Sciences Dr. Friedman possesses over 30 years of industrial managerial experience in various aspects of biopharmaceuticals and medical devices to include regulatory compliance, expert witness testimony, GLP/GMP, quality control, auditing, sterility assurance, microbiological/analytical validations and fermentation technology. Prior to becoming an independent consultant, Dr. Friedman was associated with Cambrex Bio Sciences, a contract manufacturer of GMP bulk biopharmaceuticals located in Baltimore, Maryland. As the Director of Quality Control, he managed a multi-shift Department of thirty one individuals involved in client management, the receipt and testing of raw materials, environmental monitoring and microbiology, analytical chemistry and QC compliance for the production of Phase 1, 2, 3 and commercial products manufactured from bacteria, yeast and mammalian cells. In this capacity, Dr Friedman enjoyed many client and regulatory interactions, both domestic and international. Prior to 2000, Dr. Friedman was the Laboratory Director for Chesapeake Biological Laboratories, a contract Aseptic Fill n' Finish manufacturer located in Baltimore, Maryland. In addition to the professional history listed above, other associations have included W.R. Grace, Sigma Chemical Co., Sherwood Medical, Becton Dickinson, American Cyanamid and Union Carbide. Dr. Friedman received his B.S. degree in Microbiology from Ohio State University, his M.S. from Michigan State University in Microbial Genetics, and his PhD from Ohio State University in Microbiology. For more information about this training visit https://www.researchandmarkets.com/r/h4uyyq About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. 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WEDNESDAY, Nov. 20, 2024 -- In pregnant women, the oral microbiome is associated with stress and mental health, according to a study published online Nov. 19 in BMJ Mental Health . Ann M. Alex, Ph.D., from Michigan State University in East Lansing, and colleagues explored a potential oral-brain-behavior axis related to maternal mental health using saliva samples obtained from 224 women in their second trimester oversampled for stress. The association between oralome data and women's recent or cumulative pregnancy stress, trait and state anxiety , depression symptoms, and posttraumatic stress disorder (PTSD) symptoms was examined. The researchers identified higher oral alpha diversity in pregnant women in the high trait anxiety or depression symptom groups, indicating higher richness of species within samples. Beta diversity differed in groups with high and low PTSD symptoms, reflecting differences in community composition. Women with high versus low life stress, anxiety, depression, and PTSD had differently abundant microbes, with the affected microbes mainly differing by symptom. Women with high recent life stress had more abundant members of phylum Proteobacteria, and women with high depression symptoms had more abundant Spirochaetes . In the high trait anxiety and high depression groups, members of phylum Firmicutes were more abundant, while women with high trait or state anxiety or experiencing high depression symptoms had lower genus Dialister ; genus Eikenella was elevated with high trait anxiety, depression, or PTSD. "Our study shows that numerous aspects of the oral microbiome in pregnancy are associated with women's life stress and mental health," the authors write. Abstract/Full Text Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

Findings are the first, peer-reviewed evidence of gene-edited microbes supplying a material proportion of corn farmers' nitrogen in commercial production BERKELEY, Calif., Nov. 13, 2024 /PRNewswire/ -- Peer-reviewed research published today in Scientific Reports describes a new technology that could revolutionize a century-old approach to providing nitrogen to crops. The study, a collaboration of researchers from the University of Wisconsin-Madison, Purdue University, and Pivot Bio, a leading sustainable agriculture company, presented first-of-its-kind evidence showing how gene-editing enhances microbes' ability to fix atmospheric nitrogen and transfer it to cereal crops. Continue Reading First-of-its-kind evidence showing gene-editing enhancing microbes' ability to fix atmospheric nitrogen for cereal crops Post this A scientist at Pivot Bio scraping corn roots to measure the colonization of Pivot Bio's nitrogen producing microbe. Using isotopically labeled nitrogen, researchers traced nitrogen in the air to chlorophyll of corn leaves, providing evidence that it was fixed from the air by the gene-edited microbes. Field studies also showed that these microbes could fix and supply nitrogen comparable to up to 40 pounds of synthetic nitrogen fertilizer with similar yields. Improving the effectiveness of nitrogen fertilizers has been a long-standing challenge. "The core issue," explains Dr. Bruno Basso, a professor of environmental science at Michigan State University, who was not involved in the study, "is that the soil-plant-atmosphere system is extremely complex." Unpredictable weather makes it difficult to match nutrient supply to plants' demand, and to determine precisely how much nitrogen a crop will require and whether the nutrient will remain in the soil. "My research lab has spent years helping farmers, using advanced sensing technology and computer models to help them better understand their fields and use nitrogen fertilizer more efficiently to increase profit and reduce environmental impact, such as nutrient losses to groundwater and greenhouse gas emissions to the atmosphere." Diazotrophs, special types of bacteria that occur in nature, have a unique ability to turn atmospheric nitrogen gas into ammonium, the building block of amino acids and proteins. This process, commonly known as biological nitrogen fixation (BNF), was the main form of nitrogen nutrition for crops for thousands of years before synthetic nitrogen fertilizer was invented. "Native soil diazotrophs lose their ability to perform BNF when exposed to high concentrations of nitrogen in the soil for extended periods of time. This is an evolutionary response to conserve energy because BNF is a very energy-intensive process," explains Dr. Jean-Michel Ané, professor of bacteriology and plant and agroecosystem sciences at the University of Wisconsin-Madison, a co-author of the study. "We need to convince these bacteria to maintain high levels of BNF in environments with lots of nitrogen, such as synthetically fertilized soils." Researchers at Pivot Bio developed gene-edited microbes using non-transgenic methods to enable diazotrophs to continue providing nitrogen to the crop even under high nitrogen conditions. "With the gene edits, we blind microbes to the presence of nitrogen in their surroundings, so they continue to fix ammonium, delivering it directly on the root system," said Dr. Karsten Temme, chief innovation officer and co-founder at Pivot Bio and a co-author of the paper. "We also introduced other edits to ensure the bacteria can transfer the fixed nitrogen to the crop instead of keeping it for itself." The paper presents evidence of this process happening in the lab and field test plots. It is also the first peer-reviewed paper covering PROVEN® 40, Pivot Bio's second-generation commercial product for corn containing gene-edited nitrogen-fixing microbes. "Nitrogen fertilizer is arguably the most significant invention of the past century and will be essential to the world's development and food security for the foreseeable future. However, we believe it can be used better," said Dr. Temme. "Pivot Bio's focus is on improving the productivity of farming by increasing the efficiency of nitrogen with our gene-edited microbes and reducing losses of synthetic fertilizer to the environment." In the field, the researchers used a variety of isotopic experiments to again demonstrate nitrogen fixation, this time under real-world conditions, and quantify the nitrogen levels in the plant. They also collected hundreds of samples from farmers who reduced nitrogen fertilizer rate by 35 to 40 pounds of nitrogen per acre, replacing it with Pivot Bio's PROVEN 40. On average, researchers found plants treated with PROVEN 40 had higher nitrogen levels early in the season and no negative impacts on yield, even though they had received less synthetic fertilizer. "It is very hard to keep track of nitrogen as it moves from the air to the microbe and then to the plant. We rely on the isotopic signatures of nitrogen atoms coming from the air versus those in the soil," Dr. Ané explains. With these measurements, researchers detected isotopically labeled nitrogen in the chlorophyll of corn leaves in the lab, a sign that microbes supplied that nitrogen to the plant. "This extensive research is promising because it means that farmers can start reducing nitrogen fertilizer without compromising productivity: a win-win for the farmer and the environment," said Dr. Temme. "This is very exciting because the technology is highly scalable. Our products have already been used on over 13 million acres in the U.S. since their commercial launch five years ago, which translates into real impact." Dr. Basso agrees. "If this technology continues to improve and deliver more nitrogen to crops, and they show this translates to reductions of environmental pollution and the overall agricultural carbon footprint, it could be a game changer for nitrogen management. The more we replace synthetic fertilizer for more efficient and sustainable sources of nitrogen to support crop yield, the better is for farmers, communities and the environment." The full paper can be found in Scientific Reports. Founded in 2011, Scientific Reports is an open-access journal from the Nature Portfolio, publishing notable original research across the natural and clinical sciences and known for its rigorous peer review process. About Pivot Bio Pivot Bio is a leading sustainable agriculture company delivering to farmers patented crop nutrition technologies that harness the power of nature to reliably and productively grow the food the world needs in the face of increasing volatility. Currently available in North America, and soon in Brazil, the company's products are a breakthrough innovation. They are among the industry's most promising climate solutions. The company's nitrogen is weatherproof, safer to handle, and does not leach or contribute to nitrous oxide emissions. Pivot Bio has been recognized three times by Time magazine on its annual list of best inventions, by Fast Company on its World Changing Ideas and World's 50 Most Innovative Companies lists, by CNBC on its Disruptor 50 list of private companies, by Fortune on its Impact 20 list of startups driving social good and by MIT Tech Review as one of 15 climate tech companies to watch. For more information, visit PivotBio.com. SOURCE Pivot Bio, Inc WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED