FDA Law Blog

JANUARY 4, 2023

The purpose of these town halls are to discuss topics related to OTAT-regulated products, engage with product development stakeholders, and to provide information to help stakeholders to help advance drug development. The next town hall will focus on the clinical development of gene therapy products for rare diseases in February 2023.

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Drug Discovery World

MARCH 27, 2023

Learn more about the trends, insights, and perspectives from ACROBiosystems as a manufacturer of cell therapy reagents, including topics like: CAR-NK research Developing new CAR constructs Evaluation CAR expression detection Role of GMP Manufacturing in cell therapy The post Diving deep into cell therapy: An industry perspective appeared first on Drug (..)

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Reagent Manufacturing Development Drugs 52

Drug Discovery World

JANUARY 30, 2024

Viral vector manufacturing At the Advanced Therapies Awards ceremony, Dr Luigi Naldini, Director of the San Raffaele Telethon Institute for Gene Therapy, was awarded a Lifetime Achievement Award in recognition of ‘extraordinary contributions to gene therapy’, a field he has helped shape through his pioneering work on lentiviral vectors.

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Gene Therapy Manufacturing Gene Clinical Trials 71

Drug Discovery World

MARCH 27, 2023

Learn more about the trends, insights, and perspectives from ACROBiosystems as a manufacturer of cell therapy reagents, including topics like: CAR-NK research Developing new CAR constructs Evaluation CAR expression detection Role of GMP Manufacturing in cell therapy Download now.

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Reagent Manufacturing Development Research 52

Drug Discovery World

OCTOBER 13, 2022

The DDW team spent 4-5 October, 2022 at ELRIG’s annual meeting, Drug Discovery 2022, which remains Europe’s largest meeting for life sciences industry professionals and took place at ExCel, London, UK. Drug Discovery 2022: The numbers . Drug Discovery 2022: The numbers . Of those delegates, 75% work in drug discovery.

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Drugs In-Vivo In-Vitro Biobanking 52

Drug Discovery World

APRIL 3, 2023

As the industry’s awareness of alternatives to traditional antibodies continues to grow, there is increasing demand for these alternatives, which we are seeing particularly within the therapeutic sector, to enable targeted therapeutics and enable the emerging gene therapy market. DS: The company now has clients across big pharma.

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Antibody Gene Therapy Gene In-Vitro 52

Drug Discovery World

MAY 7, 2024

It is up to the end-users and vendors to collaborate and put forth innovative solutions that will aid in driving quicker and more robust mAb production for complex biological processes, leading to quicker and cheaper drug product for patients. RA: What impact do improvements to these processes have on drug discovery and development?

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Antibody Production Manufacturing Engineer 59

pharmaphorum

DECEMBER 16, 2022

Generative AI drug creation company Absci Corporation has added Dan Rabinovitsj (as pictured), VP of connectivity at Meta, to its Board of Directors. Optibrium, another software developer in the AI drug discovery space, has appointed Ian Smith as its new chief technology officer. AI and robotics hires. McKinnell, Jr.

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Behavioural Health Reagent Gene Therapy Production 52

Roots Analysis

FEBRUARY 21, 2022

Moreover, the manual protocols require extensive manipulation, costly reagents and long duration of skilled genomic library production. As a result, NGS library preparation kits have emerged as an innovative technology to overcome the challenges associated with conventional library preparation protocols. Nanoparticles Contract Manufacturing.

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Marketing Gene Sequencing DNA Genome 52

Drug Discovery World

MARCH 13, 2023

The cell and gene therapy (CGT) landscape has grown significantly in the past year. Between the 24 therapies already approved by the FDA 1 and a marked increase in clinical trials, widespread accessibility to precision medicine feels within reach. But now, the increased efficiency is likely making drug development cheaper.

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Gene Therapy Gene Manufacturing Development 52

Roots Analysis

FEBRUARY 23, 2022

In the past two years, close to 3,220 patents related to NGS library preparation kits and reagents have been filed / granted, indicating the heightened pace of innovation. Next Generation Sequencing (NGS) Library Preparation Kits. Strong Intellectual Property Portfolio. Next Generation Sequencing (NGS) Library Preparation Kits. Web: [link].

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Genetics DNA RNA Reagent 52

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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Genome Genomics Medicine Gene Therapy 244

Drug Discovery World

DECEMBER 23, 2022

GenScript USA has expanded its global current Good Manufacturing Practices (cGMP) single-guide RNA (sgRNA) manufacturing capabilities to meet the growing demand for cell and gene therapies. . The 400,000 square-foot cGMP facility enables gene and cell therapy R&D programmes to advance IND filings and clinical trials.

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Gene Therapy Gene Reagent Clinical Trials 52

Drug Discovery World

SEPTEMBER 28, 2022

To further streamline the customer experience, optimised reagent kits with validated antibodies from PerkinElmer’s BioLegend business are also part of the solution. . The post Cell analysis system could streamline cell and gene therapy manufacturing appeared first on Drug Discovery World (DDW). ” . .

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Gene Therapy Manufacturing Gene Reagent 52

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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DNA Manufacturing Gene Therapy Gene 52

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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Gene Therapy Gene Antibody Production 52

Drug Discovery World

OCTOBER 12, 2022

Furthermore, the sensitivity of the fluorescent label was shown to be around x100 greater than 2-aminobenzamide, a reagent that has been used extensively in the past to label glycans. . Agilent’s next round of collaboration will look at cell and gene therapy glycan applications. Drug Discov. The glycan database .

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Protein Gene Therapy Antibody Production 52

Drug Discovery World

JUNE 14, 2023

In acknowledgement of Blood Donor Day 2023, DDW spoke with industry experts about the significance of blood donorship in drug discovery. In addition to the collection, processing and storing of adult blood projects, BCA is also involved in providing umbilical cord blood and other tissue products as critical components of cell therapies.

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Manufacturing Production Gene Therapy Development 52

Drug Discovery World

FEBRUARY 27, 2023

The company launched its EnVision Nexus system at the show, which is designed for demanding HTS applications and to help accelerate drug discovery efforts. As the company’s first HT system, it has been designed to overcome adoption barriers currently limiting the use of predictive human liver models within drug discovery workflows.

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Drugs Life Science Protein Scientist 52

Drug Discovery World

DECEMBER 15, 2022

Improve delivery: Clinical translation of gene therapy is dependent on the efficient and safe delivery of gene editing tools into cells, and this can occur either ex vivo or in vivo. The post Delivering on the promise of gene editing appeared first on Drug Discovery World (DDW). In one example, Choi et al.

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Gene Editing Gene In-Vivo Genome 52

Drug Discovery World

JULY 18, 2023

Rolf Turk , Senior Manager, Genomics Medicine at Integrated DNA Technologies, examines how CRISPR is being used to enhance cancer therapies. Nucleic acid-based diagnostics, which typically require PCR reagents and laboratory equipment, are crucial for identifying, treating, and preventing common infectious diseases.

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