Drug Patent Watch

DECEMBER 17, 2024

Benefits of FMS in Pharmaceutical Manufacturing Space efficiency Reduced risk of cross-contamination Increased production speed Adaptability to various processes and products Why Flexibility Matters in CDMO Partnerships In an industry where change is the only constant, flexibility can mean the difference between success and failure.

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XTalks

JULY 26, 2021

The authors concluded that the relatively high levels of the bacteria enterococci indicated that food safety was a concern for these products due to potential infections, antibiotic resistance and gene transfer associated with the bacteria E. The storage and handling of these products should mimic that of raw meats,” the authors wrote.

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Pharmaceutical Technology

APRIL 4, 2023

There are 13 sites in the region that offer API biologic services and 12 of these are based in Telangana, all offering protein and peptide manufacturing, and one – Loka Biosciences (Hyderabad, Telangana, India) – also offers gene therapy production. Source: GlobalData, Pharma Intelligence Center Drug Database (Accessed March 20, 2023).

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Advarra

JULY 28, 2022

This article explores how these tools work and why biosafety cabinets are preferred in research involving cell and gene therapies. 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. What is a Biosafety Cabinet?

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pharmaphorum

MARCH 22, 2022

The challenges posed to manufacture these new therapies falls in line with the complexity of the therapies themselves, with a number of breakthroughs in the next generation of therapies being particularly challenging to produce at scale, such as cell and gene therapies. Taking manufacturing to the next level.

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Advarra

MARCH 31, 2023

The use of engineered genetic materials in clinical trials is rapidly expanding, with potential applications for genetic vaccines, gene-modified cellular therapies, and gene therapies. Gene Delivery Systems Genetic material, in the form of DNA or RNA, does not easily enter cells without the aid of a delivery system.

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The Pharma Data

JANUARY 10, 2021

Recent research has shown that virus contamination of environmental surfaces may lead to viral transfer and therefore an acceleration of outbreaks. The kit is highly specific for the two regions N1/N2 on the SARS-CoV-2 N-gene, ensuring reliable results with a two target approach.

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Roots Analysis

APRIL 15, 2024

These complex entities, such as antibodies, antibody drug conjugates, cell therapies, gene therapies, and therapeutic proteins, are highly specific molecules that are designed to precisely target biomarkers associated with a particular disease pathway.

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FDA Law Blog

NOVEMBER 1, 2022

USP opened the workshop with a description of its organization, each of its applicable standards for advanced therapies, including its standards (general chapters) <1046> Cell and Tissue Based Products and <1047> Gene Therapy Products, and its microbial related chapters open for comment: <74> Solid Phase Cytometry-Based Rapid (..)

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Roots Analysis

SEPTEMBER 18, 2023

Biologics: Gene therapy and cell therapy-based futuristic treatments fall under the category of advanced therapy medicinal products ( ATMPs ) and offer opportunities to individuals suffering from a variety of illnesses, including various types of cancers.

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Roots Analysis

SEPTEMBER 20, 2023

It is important to highlight that cell and gene therapies have been used to treat an array of medical conditions for which no other treatments are available. Contamination is a key concern when it comes to manufacturing cell therapy products.

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Roots Analysis

OCTOBER 24, 2023

The limitations of stainless-steel bioreactors such as high risk of contamination, process related challenges and high operational cost have prompted innovators to develop more advanced single use bioreactor in order to meet the rising demand for safe and efficacious biotherapeutics.

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Roots Analysis

AUGUST 30, 2023

Further, in the same year, nearly half of the biologic approvals were allotted to novel class of modalities, including antibody drug conjugates (ADCs), bispecific antibodies, cell therapies and gene therapies. Specifically, advancements in niche segments is expected to culminate in accelerated growth of the biologics market.

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XTalks

NOVEMBER 7, 2022

Such information can reveal details about tumor staging, tumor progression, heterogeneity, gene mutations and clonal evolution. 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.

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Roots Analysis

OCTOBER 11, 2023

To balance these factors, we can expect to see an increased collaboration between manufacturers, suppliers, and regulatory agencies to ensure safe, and contamination-free bio innovations. The following figure presents some of the key market drivers and restraints in the agricultural biologicals domain.

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The Pharma Data

MAY 13, 2021

every day are contaminated with at LEAST ONE TOXIC ingredient. food is “A food in which the gene from one species has been forced into the DNA of another species and the process itself creates all sorts of unpredicted side effects.”. These ingredients can be harmful and even LIFE THREATENING. A better definition of a G.M.O.

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Roots Analysis

FEBRUARY 1, 2024

In the absence of suitable temperature controlled packaging solutions, the products packaged, such as vaccines, biologics, cell and gene therapies might get exposed to extreme ambient temperatures. Microbial contamination due to poorly maintained freezers and fridges.

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XTalks

MAY 29, 2024

Issues of nitrosamine contamination during manufacturing have also plagued Januvia since 2022, compounding the decline in sales. Other notable FDA approvals included Zavzpret , the first and only calcitonin gene-related peptide (CGRP) receptor antagonist nasal spray for the acute treatment of migraine, and alopecia drug Litfulo.

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Pharmaceutical Technology

APRIL 27, 2023

GlobalData pharmaceutical analysts project that RNA-based gene therapies for oncology will grow from zero in 2022 to $4.6 Every stage of development should result in a reproducible, safe drug product with no cross contamination from one batch to another. billion by 2028.

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Pharmaceutical Technology

MAY 17, 2023

One big challenge is contamination. It can cost millions of dollars to remove contamination from a manufacturing process and this causes a consequent delay to the preparation of the drug. As with contamination, variation in outcomes and product quality are often a result of the raw materials used.

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XTalks

JANUARY 6, 2025

Gene Editing CRISPR-Cas9 and related gene-editing technologies continue to advance, and today they are widely used to study and develop therapeutic approaches for a broad range of human diseases. As of March 18, 2024, the FDA has approved 36 gene therapies, with an additional 500 therapies in the pipeline.

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XTalks

SEPTEMBER 14, 2020

Results are available in about 15 minutes, so the test is much faster than currently available tests which detect viral genes. There is also a risk of the mask becoming contaminated from viral droplets while on the face and once contaminated, the virus may get into the eyes, nose or mouth when the mask is removed.

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