pharmaphorum

FEBRUARY 3, 2022

Light is being shed on recent product recalls for mould contamination, and infection outbreaks serve as a reminder to pay more attention to these overlooked organisms, as well as considerations towards container closure integrity testing which is being increasingly deployed to block microbe movement. View the full agenda: [link].

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Contamination Scientist Manufacturing Production 52

XTalks

MARCH 25, 2022

Last summer, Pfizer recalled a dozen lots of its smoking cessation drug Chantix due to nitrosamine contaminants. The US Food and Drug Administration (FDA) has recognized the increasing problem of nitrosamine contamination in human drugs.

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Contamination Drugs Production Manufacturing 95

XTalks

JULY 18, 2023

The drugmaker is facing more than 38,000 talc-related lawsuits, mostly over its iconic baby powder which plaintiffs claim was contaminated with asbestos that caused ovarian cancer and mesothelioma.

Research 95

Research Contamination Doctors Doctor 95

Scienmag

DECEMBER 8, 2020

Odds of exceeding maximum contaminant levels were significantly greater for water systems in the Southwest and serving Hispanic communities A new national study of public water systems found that arsenic levels were not uniform across the U.S., even after implementation of the latest national regulatory standard.

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Contamination Life Science Cardiology Medicine 41

XTalks

DECEMBER 14, 2020

Amneal acquired AvKARE in December 2019, just one month after the company announced a voluntary nationwide recall of generic ranitidine due to potential contamination with N-nitrosodimethylamine (NDMA), an environmental contaminant and possible human carcinogen.

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Packaging Packaging Drugs Generic Pharmaceutical 98

Pharmaceutical Technology

JULY 22, 2022

Peter Hotez’s tweet on PAI Life Sciences’ phase 1 trial of its snail fever vaccine. Schistosomiasis, also called the snail fever, is caused by parasitic flatworms that enter the human skin when individuals come in contact with contaminated water, the article noted. Retweets: 113.

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Vaccination Vaccine Life Science Immune Response 130

XTalks

APRIL 12, 2023

Since around 2009, Johnson & Johnson has been facing over 40,000 lawsuits from people alleging that its talc-based baby powder causes cancers like ovarian cancer and mesothelioma due to asbestos contamination.

Contamination 98

Contamination Cosmetics Production Sales 98

XTalks

JULY 25, 2023

While there is no evidence of person-to-person transmission, anthrax skin lesions may be contagious through direct contact or contaminated objects. The bacteria usually enter the body through wounds, but infection can also occur through contaminated meat or inhalation of spores.

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FDA Approval Vaccination Vaccine Antibody 98

XTalks

NOVEMBER 7, 2023

Implementing protocols to ensure safety and prevent contamination in their work environment. Medical science liaisons are in great demand due to their critical function within life science organizations. A medical science liaison’s expertise and proficiency significantly enhance a company’s credibility.

Doctors 59

Doctors Doctor Life Science Production 59

pharmaphorum

JULY 25, 2022

“You don’t want cross-contamination to occur. The way we designed the unit, air inlet comes in, in the passage while the outlet is on top of a patient’s bed, which means it is uniflow and, hence, cross-contamination is minimal.” About the author.

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Contamination Marketing Life Science Engineer 122

XTalks

DECEMBER 14, 2020

Amneal acquired AvKARE in December 2019, just one month after the company announced a voluntary nationwide recall of generic ranitidine due to potential contamination with N-nitrosodimethylamine (NDMA), an environmental contaminant and possible human carcinogen.

Packaging 52

Packaging Packaging Drugs Generic Pharmaceutical 52

Roots Analysis

AUGUST 30, 2023

Other key benefits of digital biomanufacturing include improved efficiency, higher product yield, better product quality, data integrity, reduced manual intervention and limited risk of contamination. For instance, since 2020, there has been a gradual increase in the number of mergers and acquisitions in this domain.

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Manufacturing Production Contamination Gene Therapy 40

Cloudbyz

NOVEMBER 9, 2021

Advantages gained from digitalization are certainly not limited to Human Biosample Management (HBSM) or any other applied aspects of the Life Sciences. If you find out a sample was contaminated at the source, you can alert all relevant personnel within a matter of seconds before confirming they all received the alert in person.

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Biobanking Contamination Life Science Packaging 80

Drug Discovery World

MAY 22, 2023

Closed and automated systems are an oft-cited solution to the problems of process variability and contamination, and even under the particularly delicate therapeutic modalities of CGT, technical innovation has come along leaps and bounds over the past 10 years.

Gene Therapy 52

Gene Therapy Gene Drugs Contamination 52

XTalks

JANUARY 4, 2023

In addition, NexoBrid is not recommended for wounds contaminated with hazardous substances to avoid a greater risk of spreading the dangerous substance and any unpredictable reactions with the drug product.

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FDA Approval Clinical Trials Clinical Trials Contamination 98

XTalks

AUGUST 3, 2021

Concerns of asbestos contamination in Johnson & Johnson’s talc-based formulations have been around since the 1970s, with the company accused of ignoring and failing to report them to the US Food and Drug Administration (FDA).

Containment 98

Containment Production Contamination Marketing 98

XTalks

JULY 22, 2021

Related: Johnson & Johnson Pulls Neutrogena and Aveeno Spray Sunscreens Over Benzene Contamination. As such, the company said the health benefits of curbing smoking outweigh the theoretical potential cancer risk from the nitrosamine impurity in the drug. Pfizer said the benefit/risk profile of Chantix remains positive.

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Drugs Doctors Doctor Branding 98

XTalks

FEBRUARY 21, 2022

The company also said that quality control is a crucial aspect of the manufacturing process, which is why it will help to ensure the identity, composition, strength, purity (including the absence of product- and process-related impurities) and absence of microbiological contamination of each batch that is produced.

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Vaccination Vaccine Production Manufacturing 105

Drug Discovery World

OCTOBER 5, 2022

The company hopes that through its technology, academics, life science industries and pharma industries can test and develop more personalised treatments for intricate tissue engineering and cell therapy, such as repairing damaged tissue, replacing lost biological functions, localised therapeutic solutions and complex drug formulations. .

Drugs 52

Drugs Regulation Manufacturing Medicine 52

Advarra

SEPTEMBER 14, 2023

GDP provides distributors with auditable systems to ensure safe storage and transport, contamination prevention, and recall management, while helping make certain only authorized products enter the distribution network. Finally, GDP governs the wholesale distribution of medicines , keeping products safe and in usable condition for consumers.

Clinical Research 52

Clinical Research Compliance Research Clinical Trials 52

Pharma in Brief

AUGUST 9, 2021

Requirements relating to biologics’ starting and auxiliary materials, controlling the contamination of biologics, and biologics’ storage and transportation requirements would be replaced with more flexible conditions which apply more broadly. Manufacturing Controls.

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Regulation Drugs Manufacturing Production 98

XTalks

MARCH 10, 2022

Mined talc is prone to asbestos contamination because the two minerals are often found together in nature. Kligman’s human experimentations were known at the time and for decades afterward, appearing in newspapers and books; however, Johnson & Johnson’s involvement in them has only been revealed now.

Containment 98

Containment Dermatology Contamination Sales 98

XTalks

AUGUST 3, 2023

Johnson & Johnson’s latest bankruptcy attempt, tied to its proposed $8.9 billion settlement for talc litigations, has been shot down by the United States Bankruptcy Court for the District of New Jersey.

Compliance 98

Compliance Contamination Research Life Science 98

XTalks

FEBRUARY 8, 2024

Diabetes remains a critical global challenge, affecting millions of lives and commanding significant attention from the medical, life sciences and pharmaceutical sectors. In 2022, Januvia was flagged for nitrosamine contamination , a potential carcinogen commonly produced as a byproduct during drug manufacturing.

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Sales Insulin FDA Approval Drugs 52

Cloudbyz

NOVEMBER 3, 2021

Before deploying collected samples for a project, small portions from those samples are retained as a precautionary measure, to account for any potential destruction or contamination of the originally designated portions of the samples. Let’s use the easiest example of a sample. But a new trend is making changes to this model.

Biobanking 52

Biobanking Clinical Research Contamination Research 52

Pharmaceutical Technology

FEBRUARY 3, 2023

Free Whitepaper Environmental monitoring for closed robotic workcells used in aseptic processing Recognising that human operators are a major potential source of contamination in aseptic processing, a global study was set up to examine the use of closed robotic workcells. Biores Open Access. 2020 Oct 16;9(1):219-228. doi: 10.1089/biores.2020.0031.

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Genome Genomics Medicine Gene Therapy 244

Drug Discovery World

APRIL 25, 2024

The market for cell line development is currently rising due to an increased focus by the life sciences sector on biopharmaceuticals and targeted therapies. He has worked in life sciences and pharmaceutical B2B publishing for seven years and was previously Editor of European Pharmaceutical Manufacturer.

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Development Protein In-Vivo Life Science 59

XTalks

NOVEMBER 7, 2022

However, Dr. Bahassi reported that the selection of CTCs using this method is often not very efficient and the CTC population is usually highly contaminated with leukocytes. This is a negative CTC selection technique because CD45 markers are used to remove white blood cells from the sample, leaving CTCs behind.

Clinical Trials 98

Clinical Trials Clinical Trials Trials FDA Approval 98

pharmaphorum

NOVEMBER 24, 2022

Cleanrooms are critical in the development of pharmaceuticals, offering a controlled environment free from contamination to test new drugs and therapeutic devices. The pharmaceutical and life sciences services provider recently revealed its latest partnership with Moderna, collaborating for renting of COD services across the US.

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Manufacturing Pharma Packaging Packaging Packaging 98

XTalks

MAY 13, 2022

Leachables are inorganic or organic chemical entities that leach into a product from packaging materials under normal storage conditions or during accelerated product stability studies i.e. simulating actual use of a product or shelf life. These compounds thus become a part of the drug matrix.

Packaging 98

Packaging Packaging Containment Production 98

Drug Discovery World

NOVEMBER 1, 2023

The company will explain how Monipa could make infrared spectroscopy a highly practical and cost-effective inline monitoring solution for the biopharmaceutical industry.

Life Science 52

Life Science Contamination Gene Therapy Manufacturing 52

XTalks

FEBRUARY 26, 2021

It wasn’t until the early 1970s when large numbers of other cell lines were found to be contaminated with HeLa in some labs that an investigation was launched. After her death, Lacks’ family remained unaware that her cells were being used in labs around the world and fueling groundbreaking scientific discoveries.

Scientist 69

Scientist Research Genetics Cosmetics 69

Delveinsight

SEPTEMBER 8, 2021

Especially in the field of Pharmaceutical & Life Sciences, a company’s all-around product life-cycle stages, which consist of planning, designing, constructing, product testing, and commissioning processes are provided by a Pharma Consultant. Pharma Consultant. Pharma Consultancy Modus Operandi.

Marketing 52

Marketing Production Sales Life Science 52

XTalks

AUGUST 7, 2023

Transmission of the molluscum contagiosum virus occurs through direct person-to-person contact or via contaminated objects known as fomites. Immunocompromised individuals are particularly vulnerable to complications and may develop larger lesions.

FDA Approval 98

FDA Approval Dermatology Clinical Trials Clinical Trials 98

Drug Discovery World

AUGUST 10, 2022

Although this type of contamination has not yet been reported in humans, RCVs can form rapidly growing T cell neoplasms, another type of cancer. Once CAR T cells are designed to target the correct tissue, have been successfully manufactured, and are free of harmful contaminants, they are ready for administration to patients.

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Manufacturing Gene Genome Genomics 98

The Pharma Data

NOVEMBER 15, 2020

She chairs the board of directors of Sellas Life Sciences, a publicly traded biotechnology company, chairs its nominations & governance committee, and is a member of its audit, compensation and finance committees. and international leadership positions, including Staff Vice President and Associate General Counsel.

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Clinical Trials Clinical Trials Production Trials 40

XTalks

MAY 20, 2022

She said it is also spread through open sores, contact with bodily fluids or by touching contaminated clothes or bedding. Mylène Drouin said the monkeypox virus is not sexually transmitted and is mainly spread “by close contact and [respiratory] droplets.”. Treatments.

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Vaccination Vaccine Contamination Licensing 98