Drug Discovery World

APRIL 17, 2024

Recombinant adeno-associated viruses (rAAVs) are considered a promising delivery system for gene therapy medicines. This webinar will detail how Oxford Nanopore evaluated long-read nanopore sequencing as a comprehensive and sensitive QC method for rAAVs which is supporting internal research activities at AstraZeneca.

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Drug Discovery World

MAY 19, 2023

This paid-for advertorial by Astrea Bioseparations appeared in DDW Volume 24 – Issue 1, Winter 2022/2023 – Cell and Gene Therapy Guide. Therapeutic developers face significant challenges in purifying cell and gene therapy (CGT) modalities.

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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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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. ©GlobalData.

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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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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.

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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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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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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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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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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. 1] BioNews. Hemophilia News Today. link] [2] Tang Q, et al.

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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

Although this type of contamination has not yet been reported in humans, RCVs can form rapidly growing T cell neoplasms, another type of cancer. To prevent this from happening, the FDA recommends that manufacturers test clinical vector lots, manufactured cell products, and patients who have received treatment with CAR T cell therapy 14.

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Drug Discovery World

NOVEMBER 1, 2023

Taking place on day two of BIA BioProcess UK, the Dragon’s Den special session is focused on next generation analytical technologies and will see six companies compete for an audience vote. Chairing the session will be Julie Kerby, Managing Director of Technology and Process Innovation, Cell and Gene Therapy Catapult.

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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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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

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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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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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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