Advarra

JULY 28, 2022

This article explores how these tools work and why biosafety cabinets are preferred in research involving cell and gene therapies. Biosafety cabinets (BSCs) protect the product as well as the user and the environment. It will also spread contamination throughout the room. . What is a Biosafety Cabinet?

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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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FDA Law Blog

NOVEMBER 1, 2022

Some key points the Agency shared included the following: Your product is only as good as the process-demonstrate your manufacturing process consistently produces drug product as per your critical process parameters (CPPs). As the clinical program for the drug product matures, the CMC information should mature hand in hand.

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pharmaphorum

MARCH 22, 2022

for manufacturing, with the aim of streamlining and enabling greater automation through adoption of digital tools, is leading to greater interest in the potential for VR and AR to improve efficiency and reduce costs in production. The pharma industry’s overall push into industry 4.0 The importance of manufacturing.

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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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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. A key part of the IBC’s evaluation is assessing the risks posed by the engineered genetic materials.

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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.

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Drug Discovery World

MAY 11, 2023

Kerstin Pohl , Senior Global Marketing Manager, Gene Therapy & Nucleic Acid at SCIEX, looks at the application of liquid chromatography-mass spectrometry for analysing host cell proteins. Gene-based therapeutics and vaccines hold immense potential for more efficient and personalised treatment and prevention of complex diseases.

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Drug Discovery World

JANUARY 19, 2023

This paid-for advertorial by Catalent appeared in DDW Volume 24 – Issue 1, Winter 2022/2023 One significant challenge in the manufacturing of cell and gene therapies is the production of high-quality plasmid DNA (pDNA). Figure 1: The integrated development pathway for cell and gene therapies.

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Drug Discovery World

FEBRUARY 8, 2023

Svea Cheeseman , Refeyn, explains why better efficiency is needed to advance the production of viral vectors for use in gene therapies. Adeno-associated viruses (AAVs) are a promising, widely used vector for delivering gene therapies. Data were provided by the Cell and Gene Therapy Catapult (London, UK).

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Drug Discovery World

AUGUST 10, 2022

By Mark White, Associate Director of Biopharma Product Marketing at Bio-Rad and Marwan Alsarraj, Biopharma Segment Manager, Digital Biology Group. Although this type of contamination has not yet been reported in humans, RCVs can form rapidly growing T cell neoplasms, another type of cancer. Detecting replication-competent viruses.

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Roots Analysis

FEBRUARY 1, 2024

In terms of science, cold chain industry requires the understanding of chemical and biological processes associated with the product. This technology usually relies on physical methods to ensure desirable temperature conditions for perishable products throughout the supply chain.

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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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Pharmaceutical Technology

MAY 17, 2023

In this Q&A, Pharmaceutical Technology speaks to Sara Bursomanno, PhD Global Product Manager, Novo Nordisk Pharmatech, on insulin’s role in the past, present, and future of cell culture processes. One big challenge is contamination. At the same time, biopharmas also have to keep up with the high demand for their drug products.

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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 Excluding vaccines, there are five mRNA therapeutic products in clinical trial development as of November 2022. billion by 2028.

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