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A biologic drug (biologics) is a product that is produced from living organisms or contains components of living organisms. Biologic drugs are widely used to prevent, diagnose, treat, or cure a variety of diseases, including infectious diseases, autoimmune disorders, chronic kidney disease, and cancer. Biologics drugs are derived from a wide variety of natural sources such as human, animal, or microorganisms by using biotechnology. Moreover, Biologics include a wide variety of products such as blood and blood components, vaccines, tissues, allergenic, gene therapy, somatic cells, and recombinant therapeutic proteins. Novel therapies and new technologies are emerging to create new biologics, which holds a prominent future for the biologics market. The market is majorly driven by the increasing prevalence of chronic diseases across the globe, growing capital investment by key players, and higher acceptability and increasing demand for innovative therapies. For instance, according to the National Health Council, around 157 million Americans are expected to have more than one chronic disorder by 2020. Moreover, according to the World Health Organization, diabetes, cancer, and cardiovascular diseases account for around 1.6 million, 9 million, and 17.9 million deaths each year, respectively. Read more @ https://coherentmarketinsights-blog.blogspot.com/2020/11/increasing-prevalence-of-chronic.html

Autoclaves are also known as steam sterilizers and are used to expose each item to direct steam contact at the required temperature and pressure for the specified time. They are used for healthcare or industrial applications to eliminate the protein structure of the bacteria and spores. Compatible of steam autoclaves for crisis strategy decontamination of N95 respirators is expected to propel growth of the global steam autoclave market. For instance, in October 2020, 3M, a U.S-based multinational conglomerate corporation, announced that Belimed steam autoclaves are compatible for crisis strategy decontamination of specific single-use N95 Respirators. Moreover, launch of biological indicators for steam autoclaves is also expected to aid in growth of the market. For instance, in December 2020, Steris Corporation, a U.S-based medical equipment company, launched Spordex Self-Contained Biological Indicator Ampoules to confirm sterilization of liquids in steam autoclave cycles. Emergence of Covid-19 is expected to offer lucrative growth opportunities for players in the global steam autoclave market. For instance, globally, as of 4:03pm CET, 1 March 2021, there have been 113,820,168 confirmed cases of COVID-19, including 2,527,891 deaths, reported to the World Health Organization. Moreover, high prevalence of hospital-acquired infections is also expected to aid in growth of the market. For instance, according to an observational epidemiological study of intra-abdominal infections published in December 2019, in NEJM Journal Watch, of the 2621 critically ill adults with intra-abdominal infections at 309 international centers between January and December 2016, 32% were community-acquired, while 68% were hospital-acquired. Read more @ https://coherentmarketinsights-blog.blogspot.com/2021/03/emergence-of-covid-19-and-lunch-of-new.html

A gynecological device is a medical device that is used to promote female health or to protect and preserve reproductive health for females. This is a very broad category and includes products such as watches, calculators, bandages, and hygienic towels. While many of these products have been clinically tested and found to be safe for female health, there are still a few devices in the market that pose threats to female reproductive health. Gynecological devices usually fall into three categories: medical devices, biological safety devices, and mechanical devices. Medical devices are those that prevent the risk of injury or trauma to a woman's reproductive organs from medical interventions. Biologic safety devices are those that protect a female's health by promoting female reproductive health. Finally, mechanical devices are those that help maintain a woman's reproductive health and allow her to achieve or reach their desired fertility or pregnancy. The use of any of these unsupervised or unsafe medical procedures poses a risk to a woman's reproductive health and should be avoided at all costs. The main factors driving the growth of the gynecological devices market are the rapid increase of gynecological diseases such as uterine fibroids, endometriosis, and vaginitis and the introduction of new innovative gynecological devices in the market. For instance, according to the U.S. National Center for Biotechnology Information, approximately 97 per 1000 women suffer from gynecological diseases in the U.S., among which approximately 53 per 1000 women suffer from menstrual disorders. Rising awareness about gynecological health and preventive check-up to avoid sexually transmitted diseases (STD) is expected to boost the market growth. Moreover soaring numbers of surgical procedures such as female sterilization, endoscopy, laparoscopy, and ablation are driving the demand for gynecological devices. However strict regulatory orders by governmental bodies across the globe rel

Biosimilars, also known as biologic products, are currently the fastest growing category of medical products in the United States, with sales estimated at more than $40 billion dollars annually. When prescribed by doctors, these products may provide more effective treatment options for patients suffering from a chronic disease or condition. In late August, the FDA held a forum on biosimilars. The topic was "biosimilar medications - what are they, how do they work, and are they safe and effective." Representatives from the FDA, pharmaceutical companies, and biotechnology organizations attended the forum. The forum included individuals who are leading the charge to register biosimilar products for clinical trials. According to the FDA, the agency will begin accepting applications for biologic drugs in late fall of 2020. In Japan, various manufacturers are focused on developing pipelines that contain biosimilar candidates aimed at treating various therapeutic conditions for patients in Japan. For instance, in December 2020, Alvotech and Japanese pharmaceutical company Fuji Pharma agreed on an extension on their exclusive strategic partnership for the commercialization of four biosimilar medicines in Japan. Read more @ https://coherentmarketinsights-cmi.blogspot.com/2020/12/biosimilars-and-impact-of-covid-19.html

Immunoassays, or DNA assays, are a method of DNA analysis. DNA is the basis of all biological material, including the DNA of living organisms, cells, and tissues. This method can be used to analyze, identify, and profile various biological samples. The analysis of DNA has developed greatly over the years, due to the ability to conduct DNA tests on living people. The use of immunoassays for gene-based analysis has grown tremendously. Primarily, immunoassay analysis is used to evaluate gene-based treatments in oncology, cardiovascular, orthopedics, infectious diseases, and clinical diagnostics. Currently, the primary uses of immunoassays are for the evaluation of gene-based therapies in oncology and cardiovascular clinical trials. The analysis and measurement of immune parameters by immunoassay instruments are known as response curve analysis (RCA). The first analysis of RCA was done by Ward and coworkers in 1980, using monoclonal antibodies to stimulate the lymphocytes Subsequent immunoassay measurement models and systems have been developed to extend the scope of research and to make immunoassay measurement more cost-effective. Read more @ https://coherentmarketinsights-cmi.blogspot.com/2020/12/immunoassay-instrument-is-gaining-rapid.html

A contrast agent (also called a contrast medium) is an electrically charged material used in medical imaging to enhance the contrast of medical vessels or other tissues in the body. Contrast media/contrast agent either absorbs or changes ultrasound or electromagnetism, which is fundamentally different from radiopharms, which themselves emit electromagnetic radiation. This difference enables contrast agents to be applied to various body tissues with much higher strengths than their non-comp contrast counterparts. The most common contrast media/contrast agent used in medical imaging are CT contrast agents and MRI contrast agents. However, due to their non-magnetic nature, these medical imaging products are not able to be used on organ tissues, such as kidneys, hearts and lungs. Some manufacturers have now started manufacturing non-magnetic, biologically engineered CT and MRI contrast agents called mri-notherapy (mammography, radiofrequency ablation, and ultrasound contrast agents). High prevalence of cancer is expected to boost demand for contrast media. In the U.S., non-magnetic, biologically engineered CT and MRI contrast agents are now being used more frequently to treat patients with benign tumors of all types. Mri-notherapy is used for benign cancers of the breast (breast cancer), abdomen (belly fat), neck, head, joint (arthritis) and spine. Patients with melanoma, anemia, inoperable basilar artery disease, and multiple myeloma are also often treated with mri-notherapy. The therapy has a high success rate for benign tumors and very low incidence of mortality, espeacially in patients undergoing surgery. Moreover, recently, in November 2020, the U.S. FDA approved GE Healthcare's macrocyclic gadolinium-based MRI contrast agent, Clariscan (gadoterate meglumine), in pre-filled syringes. Read more @ https://coherentmarketinsights-cmi.blogspot.com/2020/12/high-prevalence-of-cancer-to-boost.html

It is important to ensure food safety in hospitals Hospitals being what they are - where patients of almost all kinds visit or stay - are very potent sources of infection. Infection can arise from any part of the hospital. They can spread from patients to patients, from caregivers to patients, from patients to caregivers, from patients to support or administrative staff and vice versa, and so on. An often overlooked source of infection and contamination is the food that comes into hospitals. Food safety in hospitals is a very important element of hygiene First, an understanding of food safety in the context of hospitals is necessary. Food safety in hospitals is described as the scientific way by which food is prepared, handled and stored in hospital settings. Any food that is prepared in hospital kitchens are, like food prepared in other places such as canteens, hotels and restaurants and even homes, sourced from outside. This food comes from suppliers whose hygiene has to be ensured. Food hazards can come in many forms, including, but not limited to: Biological Chemical Physical Allergenic Hazards an Several other contributing factors It is in the process of procuring materials for food and preparing it in hospital kitchens that a major part of food safety in hospitals is compromised. There has to be a thorough mechanism to ensure that all these producers and suppliers follow regulatory requirements in ensuring that the food they produce and supply to hospitals is clean and safe. Literally thousands of patients get infected from over 250 kinds of bacteria, parasites and viruses when they consume food prepared in hospitals. Findings of a recent study It is pertinent to recall the findings of study done in May 2014 in Geneva, Switzerland. It carried out an examination of chicken supplied to and prepared in a hospital in this city. An astounding four fifths of these chickens were known to have been infected with E.coli, leading to its possible transmission to pati

Course "Verification vs. Validation - Product Process Software and QMS" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: This course will review the company Master Validation Plan for major key inputs and CGMP deficiencies. It will address the FDA's newer and tougher regulatory stance. This course's aim is to prove "Product Risk Based V&V" by sufficient, targeted and documented risk-based V&V test case elements/scripts. It will teach participants to evaluate its elements against ISO 14971 and ICH Q9 for hazard analysis and product risk management. This course will evaluate different field-tested, U.S. FDA-reviewed V&V protocols; how to employ equipment/process Requirements Specs / DQs, IQs, OQs, and PQs, or their equivalents per ASTM E2500, all against a background of limited company resources. It will review a matrix that simplifies "as-product", in-product", process and equipment, et al, software VT&V, to assure key FDA requirements are not overlooked. While considering the QMS and 21 CFR Part 11; this course will make practical application of these same in two hands-on sessions. Why you should attend: This session helps participants: * Understand Verification and Validation, differences and how they work together; * Discuss recent regulatory expectations; * Know how to document a "risk-based" rationale, and use it in a resource-constrained environment; * Determine key "milestones" and "tasks" in a project; * Locate and document key subject "inputs"; * Compile "generic" Master and Individual Validation Plans; * Learn the key element of a Product V&V File/Protocol; * Understand how to develop Process and/or Production/Test Equipment V&V Files/Protocols; * Get a grasp of basic Test Case construction; * Understand sample sizes and their justification; * Learn the key elements of Software V&V expected by the FDA and how to document; * Deal with hardwa

Course "Internal Auditing for the Medical Device Industry" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: This course provides an overview of internal auditing requirements and techniques for medical device companies as a method for risk management and quality improvement. The course will cover auditing requirements, audit planning, preparation, knowledge, auditor skills, interviews, documents and records review, objective evidence, audit report writing and corrective action. Why should you attend: Attendees should attend this seminar for risk management and improvement purposes to identify weaknesses, problems, compliance risks, and improvement opportunities. Who Will Benefit: * Quality Manager * Quality Associate * Quality Engineer * Quality Technician * Regulatory Associate Agenda: Day One Lecture 1: Overview of an auditing program, principles of quality management systems and how they related to auditing, benefits of auditing, and what is auditing. Lecture 2: Types of audits, auditor qualifications, ethics, responsibilities, audit phases, audit planning, and scheduling. Lecture 3: Conducting audits, interview techniques, objective evidence, data collection, tracing, use of checklists, and reviewing documents and records. Lecture 4: Conducting process audits, running closing meetings, audit report writing, corrective actions, and improvement Day Two Lecture 1: Overview to auditing to ISO 13485 and FDA QSR. Global differences which affect auditing approaches, auditing document control and record keeping, management responsibility, and resource management. Lecture 2: Auditing order handling, design control, purchasing, and supplier controls. Lecture 3: Auditing production, validation, and preservation. inspection and testing, control of test equipment, customer property, and sterilization Lecture 4: Auditing customer feedback, internal auditing programs, complaint

Overview: The Sunshine Act, or Open Payments Program, requires manufacturers of drugs, medical devices, and biologics that participate in U.S. federal health care programs to report certain payments and items of value given to physicians and teaching hospitals. This Act was part of a healthcare reform bill adopted in March 2010. It came about due to requests for increased transparency about the financial relationships between physicians and industry. The Centers for Medicare and Medicaid (CMS) issued the final rules in 2013 which implemented the Sunshine Act. Why should you Attend: Anyone required to adhere to the Sunshine Act standards or anyone interested in knowing what must be reported and made public. Areas Covered in the Session: Purpose of the Sunshine Act Who is required to report under the Sunshine Act? What is reported? Exclusions Tracking Penalties Useful links Who Will Benefit: This webinar will provide valuable assistance to all personnel in: Human Subjects Research Healthcare interested in exploring the field of Clinical Research Clinical Research Coordinators Principal Investigators/Physicians Administration in charge of Clinical Research Regulatory Compliance Speaker Profile Sarah Fowler-Dixon is Education Specialist and instructor with Washington University School of Medicine. She has developed a comprehensive education program for human subject research which has served as a model for other institutions. She crafted budgets, policies, procedures, reporting, and training for the new program. She has initiated the planning, development, authorship and implementation of many human subjects research policies, practices, guidelines, submission and reviewer forms often working with state and federal authorities. She has provided consultation regarding ethical, federal, state, and institutional requirements for faculty and staff both in the design and execution of their projects and teaches research ethics and regulatory affairs and the fu

The research in healthcare are augmenting the global biobanking market. The biobank concept was introduced by the Icelandic parliament through an Act on health sector database in 1998. After that the US bioethics Advisory commission present a report on handling human biological specimens.

Biopharmaceuticals contract manufacturing refers to pharmaceutical companies outsourcing the development and manufacturing of drugs. It is driven by the use of advanced technologies, scientific advances, and d a highly complex research and development enterprise. It provide wide range of manufacturing services to biopharmaceutical companies. Biopharmaceutical contract manufacturing is widely used due to the complexity in manufacturing of biomolecules, as are considerably more complex, different in shape, size, and behavior than pharmaceuticals. Contract manufacturing organizations (CMOs) provide services from development of biologics to commercial scale production. Biopharmaceutical contract manufacturing involves the production of medicines in small units that can be customized to meet customer specifications. Contract manufacturers usually produce high quality and highly secure pharmaceuticals at low prices. The primary components of these drugs are plant materials and chemical substances. Biopharmaceutical companies are focused on producing numerous pharmaceuticals for the pharmaceutical industry. Read more @ https://coherentmarketinsights-cmi.blogspot.com/2021/03/biopharmaceutical-contract.html

A 3D cell culture is basically an artificial environment where biological cells are allowed to grow or interact naturally in all three dimensions, similar to how they do in vivo. Unlike 2D cultures, a 3D culture allows living cells in vitro to adopt all possible growth directions, much like how they would in the real world. This is ideal for treating diseases that involve multiple organ systems. In medicine, this is known as organo-evolution. Here are some advantages of 3D cell cultures: Unlike before, it is now possible to culture different kinds of cells such as blood, sperm, and stem cells in vitro. This was made possible by the introduction of new equipment called the culture chamber, which is used to manipulate cells in culture. Before, only two types of cells were possible to culture, monoclonal (which are typically the type found in bodily tissue) and plating (which are typically found in muscle and blood cells). In addition, the 3D cell culture can be controlled, making it more useful. For instance, researchers can use different types of media on different cells at the same time; this can help them investigate cell culture in more detail. Read more @ https://coherentmarketinsights-cmi.blogspot.com/2021/03/3d-cell-culture-allow-researchers-to.html

Fungicides are biological active substances or biocides that kill specific fungal species or fungi. A fungicide restricts their proliferation. Fungi are known to cause serious economic damages in agriculture, causing financial losses, quality, and crop loss. Increasing demand for food is expected to propel growth of the seed treatment fungicides market. For instance, according to Food and Agriculture Organization, Asia Pacific needs to increase their food production by up to 77% by 2050 to meet food demand of increasing population. Moreover, decrease in arable land is also expected to aid in growth of the market. For instance, according to the study 'Will Limited Land, Water, and Energy Control Human Population Numbers in the Future', published in the journal Human Ecology, the amount of arable land available per person will decrease to 1500m² by 2050 from 4000m² in 1961. Approval of new pesticides and fungicides is expected to offer lucrative growth opportunities for players in the seed treatment fungicides market. For instance, in December 2019, The U.S. Environmental Protection Agency approved the use of 10 pesticide products on hemp in time for the 2020 growing season, which include nine Biopesticides, under the Federal Insecticide, Fungicide and Rodenticide Act. Read more @ https://coherentmarketinsights-blog.blogspot.com/2021/03/increasing-demand-for-food-and-approval.html

Animal depression medications are usually only prescribed for depressed behavior in animals and are usually used as a stand-alone or second-line therapy, depending upon the degree of the condition. When treating depression in humans, it is most often treated with proper prescription medications, behavioral therapy, or counseling. The other classification of animal depression refers to biological causes like genetic defects and imbalances in the brain that result in depressive disorder in animals. As of now, only a few of these causes are known such as thyroid, immune system, endocrine, neurological disorders among others. However, it is believed that in the near future, a comprehensive list of the causes of depression in animals will be known. Increasing trend of pet adoption and growing pet humanization is expected to drive growth of the global animal depression medication market. Pet adoption is rapidly increasing in both developed and emerging economies. According to the American Society for the Prevention of Cruelty to Animals (ASPCA), around 6.5 million companion animals with 3.3 million dogs and 3.2 million cats enter the U.S. animal shelters nationwide every year. Read more @ https://coherentmarketinsights-blog.blogspot.com/2021/01/animal-depression-medication-market.html

Protein A colorimetric resins are the most extensively used affinity purifiers in bio-manufacturing and other industries. Protein A colorimetry is a robust, high-throughput chromatography method and is used primarily as a capture step because of its inherent precision. Approval and launch of new biosimilars is expected to propel growth of the protein A resin market. For instance, in December 2020, Sandoz Canada Inc., a generics and biosimilars manufacturer and a division of the Switzerland-based multinational Novartis AG, received Health Canada authorization for Hyrimoz (adalimumab injection, reference biologic drug: Humira) on November 4, 2020 for marketing in Canada. Hyrimoz, the new biosimilar, has been approved for the treatment of rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn's disease, ulcerative colitis, hidradenitis suppurativa, psoriasis and adult uveitis. Moreover, high prevalence of chronic diseases is also expected to aid in growth of the protein A resin market. For instance, according to the American Cancer Society, in 2019, there will be an estimated 1,762,450 new cancer cases diagnosed and 606,880 cancer deaths in the U.S. Read more @ https://coherentmarketinsights-blog.blogspot.com/2020/12/emergence-of-covid-19-to-offer_23.html

Disposable syringes are designed for one-time use and is discarded in order to prevent the spreading of infection. It can be defined as a sterile cylindrical medical instrument with a hollow needle at the end. This device act as a pump that easily draws drugs from vials and delivers these drugs to the body. A syringe is used to deliver injectable drugs in the body through an intravenous route. The growing use of injectable drugs across the healthcare sector is predominantly fueling the market growth of disposable syringes. The rise in global healthcare expenditure is another key factor propelling the market growth of disposable syringes. According to the World Health Organization, global spending on health was US$ 7.8 trillion in 2017 or about 10% of GDP and $1,080 per capita - up from US$ 7.6 trillion in 2016. Moreover, the growing demand for self-injection devices & long-acting formulations is again propelling the market growth. Increasing spending on R&D of new drugs development coupled with the growing demand for biologics will further favor the market growth of disposable syringes. Furthermore, growing concerns regarding needle stick injuries and accidental infections are also expected to bolster the market growth of disposable syringes. Read more @ https://coherentmarketinsights-blog.blogspot.com/2020/11/increasing-spending-on-r-of-new.html

Gouty arthritis is a type of arthritis that causes inflammation, typically in one joint, which begins suddenly. Gouty arthritis is caused by the deposition of needle-shaped crystals of uric acid in a joint. The primary symptoms of gouty arthritis include severe pain, swelling, and redness in joints, often in the big toe. Increasing prevalence of gout with rising alcohol consumption is expected to drive growth of the global gouty arthritis market. According to the Centers for Disease Control and Prevention (CDC), from 2013-2015 around 54.4 million adults in the U.S. have some form of arthritis, gout, rheumatoid arthritis, or fibromyalgia. According to the Arthritis Foundation, 8 million people in the U.S. suffer from gout arthritis every year. According to the same source, high intake of sugary or alcoholic drinks is one of the major risk factors for gout arthritis. Alcohol is a major source of purine, which produces uric acid. High levels of uric acids in the body can result in the formation of crystals of uric acid, eventually leading to gout. Hence, such factors are expected to drugs market is expected to drive growth of the global gouty arthritis market. Furthermore, increasing adoption of biologics and increasing R&D activities in regenerative medicines is expected to propel the global gouty arthritis market growth in the near future. Read more @ https://coherentmarketinsights-blog.blogspot.com/2021/02/gouty-arthritis-market-is-gaining.html

Toxic chemicals & materials are making their way into everyday consumer products, homes, buildings, and even more. Some toxic chemicals have been phased-out of manufacturing in the United States, including asbestos, toxic dyes, and lead-based paint. If you have been exposed to hazardous chemicals in your home or workplace, or if you are concerned about the environmental impact of your product or service, contact a lawyer. A good lawyer will investigate the dangers of chemical and material use, provide information on legal remedies available to you, and provide you with recommendations for better, safer practices. The attorneys can also help you find a chemical testing laboratory that will test the levels of chemicals in your environment to determine whether they cause negative health issues. If you are concerned about how the toxic chemicals & materials have entered your environment, consider cleaning it up yourself. For example, if you're in a business where chemicals are used or stored, you may be able to clean up contaminated waste, which may be easier than hiring a cleanup company. If you are concerned about the environmental impact of a toxic chemical, contact your local EPA. They have specific programs that address concerns about chemical contaminants. These programs include the Safe Drinking Water Act, the Environmental Protection Agency (EPA), and the Safe Handling of Hazardous Drugs and Biological Weapons Act. They all regulate the chemical and material use in our homes, businesses, and environment. Read more @ https://coherentmarketinsights-cmi.blogspot.com/2020/12/chemicals-materials-impact-of-toxic.html