Roots Analysis

JANUARY 27, 2025

Cell therapies are based on the premise that the patients own cells (autologous), or those from a healthy donor (allogeneic), can be genetically re-programmed to combat various diseases. Contamination is a key concern when it comes to manufacturing cell therapy products. This figure presents the cell therapy manufacturing steps.

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Pharmaceutical Technology

FEBRUARY 3, 2023

With scientists fervently developing mRNA vaccines, nucleic acid therapeutics, and viral vector-based gene therapies, clinicians are set to have a growing number of tools available to treat a wide range of conditions, from infectious diseases to genetic disorders and more. Biores Open Access. 2020 Oct 16;9(1):219-228. doi: 10.1089/biores.2020.0031.

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Advarra

JULY 28, 2022

Use of hazardous materials in a clean bench can increase the risk of occupational exposure and contamination of the room in which the work is being done. The hood also blows sterile (HEPA filtered air) from the top down towards the work surface to protect the product from contamination with non-sterile ambient room air. .

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Scienmag

JUNE 25, 2021

A new study by UC Davis researchers confirms the low likelihood that SARS-CoV-2 contamination on hospital surfaces is infectious. The study, published June 24 in PLOS ONE, is the original report on recovering near-complete SARS-CoV-2 genome sequences directly from surface swabs.

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The Pharma Data

NOVEMBER 10, 2020

It is important to note that the E.coli strain identified in this outbreak is not genetically related to either of the E. 15 or 16 due to possible contamination with E. coli O157:H7 outbreaks that occurred in 2019 resulting in contamination of romaine lettuce in the Salinas Valley growing area. . SILVER SPRING, Md. ,

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The Pharma Data

JANUARY 6, 2021

Two boys, a 23-month-old and a 6-year-old, developed lung cancers that proved an exact genetic match to cervical cancers within their mothers at the time of birth, Japanese researchers report. In both cases, doctors used genetic testing to positively link the mothers’ cervical cancers to the lung cancers in their sons.

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Roots Analysis

APRIL 15, 2024

Over the years, these large molecules have demonstrated promising therapeutic outcomes in the treatment of myriad of chronic and challenging disorders, including autoimmune disorders, infectious diseases, genetic disorders, and oncological disorders.

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Roots Analysis

OCTOBER 24, 2023

They consist of two or more amino acids and are synthesized naturally from transcription of a sequence of genetic code. This precaution is taken to prevent any potentially harmful contaminant from escaping the production area. This is in contrast to the containment requirements at manufacturing facilities of traditional APIs.

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Roots Analysis

SEPTEMBER 20, 2023

Cell therapies are based on the premise that the patient’s own cells ( autologous ), or those from a healthy donor ( allogeneic ), can be genetically re-programmed to combat various diseases. Contamination is a key concern when it comes to manufacturing cell therapy products.

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Roots Analysis

SEPTEMBER 18, 2023

Since gene-modified cell therapies rely on genetic alterations made outside of the body of a patient, the corresponding cells must be maintained in a stable state in an ex-vivo setting, for a predetermined amount of time. As a result, during cryopreservation processing and storage, cryomacs bags become fragile and prone to cracking.

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The Pharma Data

MAY 13, 2021

every day are contaminated with at LEAST ONE TOXIC ingredient. The REAL problem lies in the fact that most of the foods we eat today have been Genetically Modified. These ingredients can be harmful and even LIFE THREATENING. These ingredients are responsible for putting your health at risk. million deaths in the United States alone.

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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.

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FDA Law Blog

MAY 19, 2023

The submission will need to include a “detailed description of a protocol for continuous monitoring, identification, and handling of genetic mutations and/or novel isolates or strains.” Continuous Monitoring and Post Market Reporting Special Controls Within the Special Control for Risk Analysis are details regarding continuous monitoring.

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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.

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XTalks

FEBRUARY 26, 2021

The controversy continues over profits, privacy of genetic information extracted from the cells and racial inequities in access to research and healthcare. 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. Henrietta Lacks.

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Pharmaceutical Technology

APRIL 27, 2023

When combined with rapid advancement in delivery technologies, mRNA has the potential to lead to breakthroughs in the development of tailored treatment approaches in a wide range of indications from cancer to rare genetic disorders while enabling rapid responses to emerging threats.

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XTalks

JANUARY 6, 2025

Furthermore, CRISPR/Cas9 presents a promising avenue for overcoming genetic diseases in the near future. CAR-T cell therapies continue to dominate the pipeline for genetically modified cell therapies, with 97 percent of them targeting cancer. By 2025 , 10 to 20 new gene therapies are expected to gain approval each year.

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XTalks

SEPTEMBER 14, 2020

CanSino Biologics is developing a vaccine that involves snipping a bit of the virus’ genetic code off and coupling it with a harmless virus to provoke a SARS-CoV-2 immune response. Several laboratories have already shown that they can detect genetic material from the virus in wastewater.

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