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.

Engineer 52

Engineer Genetics Clinical Research Research 52

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

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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Manufacturing Production Contract Manufacturing Contamination 40

Roots Analysis

SEPTEMBER 20, 2023

In this form of therapy, patients are injected with living and intact human cells that are deemed to be capable of providing therapeutic benefit. 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.

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Manufacturing Production Contamination Gene Therapy 40

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

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.

Engineer 52

Engineer Containment In-Vivo Production 52

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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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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Packaging Packaging Containment Production 40

XTalks

MAY 29, 2024

Issues of nitrosamine contamination during manufacturing have also plagued Januvia since 2022, compounding the decline in sales. Novartis also purchased siRNA-focused DTx Pharma for $500 million upfront, which includes a preclinical therapy for an inherited neuromuscular disorder. Bristol Myers Squibb Revenue in 2023: $45.00

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Pharma Companies Sales FDA Approval Vaccine 52

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.

Insulin 130

Insulin Production Manufacturing Contamination 130

XTalks

JANUARY 6, 2025

Cell and Gene Therapies Cell and gene therapies (C&GT) remain at the forefront of healthcare innovation, representing one of the fastest-growing therapeutic areas. As of March 18, 2024, the FDA has approved 36 gene therapies, with an additional 500 therapies in the pipeline.

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