Camargo

MAY 2, 2021

Advances in scientific knowledge and growth in the cell and gene therapy space have led to a new and exciting era of medicine for patients, as well as a new motivation for regulators to provide clear, efficient pathways for product developers. Source: Medicines in Development | 2020 Update: Cell and Gene Therapy , PhRMA.

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Gene Therapy Gene Packaging Packaging 155

Drug Discovery World

JANUARY 17, 2023

Oregon State University College of Pharmacy scientists have shown that lipid nanoparticles and messenger RNA could treat blindness associated with a rare genetic condition. . Researchers developed nanoparticles able to penetrate the neural retina and deliver mRNA to the photoreceptor cells whose proper function makes vision possible. .

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Gene Editing Gene Gene Therapy Genetics 98

Drug Discovery World

JUNE 9, 2023

“DTx-1252 targets the underlying genetic lesion of the disease and leverages our Fatty Acid Ligand Conjugated OligoNucleotide (FALCON) platform to unlock the promise of RNAi therapeutics. We look forward to the continued development of DTx-1252.” and Europe.

Genetics 52

Genetics RNA Packaging Packaging 52

Pharmaceutical Technology

SEPTEMBER 20, 2022

The production of commercial dose non-sterile products such as tablets, capsules, ointments, creams, and powders is rising due to their growing global demand, attributed to increasing demand for anti-ageing products, hereditary factors, genetic mutations, exposure to harmful radiation, and rising geriatric population.

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Drug Discovery World

JULY 11, 2022

However, the speed at which CGT products can impact healthcare depends on how the industry will navigate novel challenges and risks from the nascent field of CGT development. There are over 7,000 genetic diseases that could potentially be cured using gene therapy 10. Methods& clinical development, 21,524–529. Conclusion.

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Gene Therapy Gene Development Production 52

Drug Discovery World

OCTOBER 25, 2023

DDW Editor Reece Armstrong speaks to Dr Darrell Green , Lecturer in RNA Biology Biomedical Research Centre Norwich Medical School University of East Anglia, about his work using next generation sequencing (NGS) and the areas the technology is impacting within drug discovery and development. The second concept is largely in oncology.

Bioinformatics 115

Bioinformatics Genetics RNA Drugs 115

XTalks

MAY 25, 2022

Driscoll’s curated collection of strawberries was developed through traditional breeding methods and without genetically modified organisms (GMOs). Related: Scientists Unveil Biodegradable, Antibacterial Food Packaging.

Genetics 98

Genetics Packaging Packaging Scientist 98

The Pharma Data

OCTOBER 26, 2020

Sensorion is currently advancing two preclinical gene therapy programs conducted under a broad multi-program research partnership with the Genetics and Physiology of Hearing Unit at Institut Pasteur (Paris). About Sensorion. Novasep provides cost-effective and sustainable manufacturing solutions for the life sciences industries.

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Gene Therapy Gene Manufacturing Production 52

The Pharma Data

APRIL 28, 2021

Takeda’s new solid pharmaceutical packaging building in Hikari, Japan, was recognized with the 2021 “Process Intelligence and Innovation” category award. The project at the Hikari site is a four-story building designed to elevate pharmaceutical packaging operations to a new industrial standard. For more information, visit [link].

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Manufacturing Packaging Packaging Production 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. So, we set out to solve some of the problems,” she explains.

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pharmaphorum

MAY 26, 2022

Within pharma and healthcare, where greater representation has been proven to lead to better health outcomes for all patients and the pharmaceutical companies developing medicines, change is also happening. As a Non-Clinical Assessor at MHRA he assessed non-clinical data packages for new and generic medicines. About the authors.

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Clinical Trials Clinical Trials Trials Medicine 131

Drug Discovery World

JANUARY 23, 2024

2023 was a momentous year of growth and development for the company, with the launch of a new brand identity, a state-of-the-art facility expansion, and exciting new scientific partnerships. The consortium has been awarded €3.4

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Roots Analysis

APRIL 15, 2024

Over the years, these large molecules have demonstrated promising therapeutic outcomes in the treatment of myriad of chronic and challenging disorders, including autoimmune disorders, infectious diseases, genetic disorders, and oncological disorders.

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Manufacturing Production Contract Manufacturing Contamination 40

Drug Discovery World

DECEMBER 15, 2022

Gene editing tools such as zinc finger nucleases, transcription activator-like effector nucleases (TALEN) and clustered regularly interspaced short palindromic repeat (CRISPR) nucleases have been heralded for their enormous potential to treat diseases and genetic disorders. Likewise, Lessard et al.

Gene Editing 52

Gene Editing Gene In-Vivo Genome 52

FDA Law Blog

MARCH 3, 2024

Biotechnology equipment includes genetic sequencers, mass spectrometers, polymerase chain reaction machines or any other equipment, components or accessories designed for the research, development, product, or analysis of biological materials as well as any software, firmware, or other digital components.

Genome 102

Genome Genomics Manufacturing Production 102

The Pharma Data

AUGUST 7, 2020

As the pharma industry stands firm in its commitment to advance the sector to fight Covid-19, news has emerged from the European Commission who intend to streamline the development of therapies using genetically modified organisms to treat Covid-19.

Clinical Trials 52

Clinical Trials Clinical Trials Gene Trials 52

Drug Discovery World

MAY 7, 2024

Ultimately, we owe it to patients to work together and come up with new and innovative manufacturing as well as process development approaches to accelerate the development and achieve speed to clinic. RA: In recent years, what improvements have we seen to cell-line engineering for antibodies?

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Antibody Production Manufacturing Engineer 59

pharmaphorum

JANUARY 4, 2023

Because these products can be efficiently manufactured in large batches, the approach eases some of the challenges associated with autologous cell therapies (in which a patient’ cells are collected, genetically modified, and then returned to the patient) and offers the potential to accelerate time to therapy and broaden access globally.

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Gene Therapy Manufacturing Gene Production 91

Drug Discovery World

FEBRUARY 8, 2023

The threat of empty capsids Capsids are the protein shell that would usually enclose the genetic material of a virus. In AAV therapeutics, empty capsids are those that are not packaged with the therapeutic DNA. Partially-filled capsids may also be present, and contain packaged process-related impurities or truncated genetic material.

Gene Therapy 52

Gene Therapy Gene Antibody Production 52

Pharmaceutical Technology

JUNE 18, 2023

Cholesgen (Shanghai) has announced a three-year partnership with AstraZeneca to advance research and development (R&D) in hypercholesterolemia and related metabolic diseases. The companies will validate genetic drug targets and advance therapeutic molecules into clinical development.

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Drug Discovery World

JULY 18, 2023

Years of development and fast-paced research have continued to unlock its potential, expanding how CRISPR can be used to treat, detect, and prevent common diseases such as cancer and Covid-19. CRISPR also addresses another limitation in CAR T therapies related to the insufficient quantity and poor quality of autologous T cells.

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DNA Genome Genomics RNA 98

FDA Law Blog

DECEMBER 7, 2022

This product was developed by uniQure prior to being licensed to CSL Behring. As demonstrated by the few gene therapies approved by FDA, we are still in the early days of the development and evaluation of gene therapy benefits and risks in the United States. That brings us to the product’s approval.

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Gene Therapy Gene FDA Approval Production 119

STAT News

NOVEMBER 4, 2022

Although several companies are developing  treatments based on CRISPR gene editing technology , and early data suggests that they might be safe and effective, there are no approved drugs based on the approach. Like many gene therapy companies, Cure Rare Disease packaged the therapy in adeno-associated viruses.

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Gene Editing Gene Gene Therapy Clinical Trials 105

Drug Discovery World

MARCH 13, 2023

While there is no silver bullet for increasing the availability of CGTs, improving manufacturing processes that enable their development at scale can help reduce the cost of these treatments and get them to those who need them most. But now, the increased efficiency is likely making drug development cheaper.

Gene Therapy 52

Gene Therapy Gene Manufacturing Development 52

XTalks

AUGUST 29, 2022

Cytimmune Sciences recently presented new data on their first-in-class, multi-cytokine immunotherapies at the Cytokine Drug Development Conference in Boston. In addition, following different treatment regimens, cancer cells confer genetic mutations that make these cells even more challenging for the body to recognize.

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Clinical Trials Clinical Trials Trials Drugs 95

Roots Analysis

OCTOBER 30, 2023

The next generation RNA therapeutics and RNA vaccines pipeline currently features the presence of more than 20 circular RNA therapeutics and vaccines, being developed across initial stages of drug development (discovery and preclinical).

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RNA Vaccination Vaccine Development 40

Drug Discovery World

JANUARY 10, 2023

Or, you can collaborate with our scientists to develop a custom monoclonal or polyclonal antibody, or a custom IHC or multiplex IF assay. Pillar 6: Genetic Strategies. Custom antibody development. Antibody validation. This pillar uses gene knockout or knockdown to reduce the levels of target protein available for detection.

Antibody 52

Antibody Protein Reagent Scientist 52

pharmaphorum

DECEMBER 13, 2021

The Covid-19 pandemic showed what could be done with resources and collaboration to accelerate the development of vaccines. One of its other scientific legacies was the specific development and approval of mRNA vaccines, the first in that drug class on the market. There are multiple other mRNA vaccines that are being developed.

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Drug Discovery World

FEBRUARY 6, 2023

A key breakthrough area where big data analytics has shown tremendous scope and application is in systems biology, which has bolstered holistic drug research and development, ultimately to provide patients with access to the right therapies. Figure 2: Advanced data visualisation examples for transcriptomics data.

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The Pharma Data

JANUARY 17, 2021

It received FDA guidance January 5 th and is in the midst of preparing the first package of investigational new drug (IND) applications – usually with an n-of-1, for individual patients. n-Lorem selects patients based on their genetic mutation and the organ affected rather than their specific diseases. “We

Genetics 52

Genetics Clinical Trials Clinical Trials Drugs 52

The Pharma Data

NOVEMBER 5, 2021

The final product assembly and packaging plant will support the growing demand for Amgen’s medicines in the United States and is expected to be operational by 2024. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Packaging 52

Packaging Packaging Medicine Manufacturing 52

The Pharma Data

NOVEMBER 10, 2020

coli O157:H7 strain found by Michigan Department of Agriculture and Rural Development (MDARD) in Tanimura & Antle brand packaged single head romaine lettuce. It is important to note that the E.coli strain identified in this outbreak is not genetically related to either of the E. SILVER SPRING, Md. , coli O157:H7 (STEC).

Contamination 52

Contamination Packaging Packaging Production 52

Drug Discovery World

MARCH 27, 2023

Genomics is driving a revolution in drug development and, in the long run, the state of public healthcare. Genetic insights are also guiding healthcare closer to precision medicine, enabling clinicians to tailor medical decisions or therapies to each patient. The first draft human genome took a decade to create, and 13 years to complete.

Genome 52

Genome Genomics Research Scientist 52

Drug Discovery World

AUGUST 16, 2022

Anita Ramanathan examines the importance of inclusivity and diversity throughout the drug discovery and development process. . Disparities resulting from genetic, environmental, social, and economic factors increase cancer risks in certain subpopulations, and negatively affect their health outcomes.

Research 52

Research Clinical Trials Clinical Trials Trials 52

The Pharma Data

OCTOBER 30, 2020

To develop REGN-COV2, Regeneron scientists evaluated thousands of fully-human antibodies produced by the company’s VelocImmune ® mice, which have been genetically modified to have a human immune system, as well as antibodies identified from humans who have recovered from COVID-19.

Production 52

Production Antibody Manufacturing Trials 52

The Pharma Data

DECEMBER 16, 2020

Gustave Perna, who oversees the logistics for Operation Warp Speed, told reporters earlier this week that McKesson will package and distribute the vaccine to more than 3,000 sites across the country. Instead, it uses a genetic code, which tricks the body into developing an immune response to the virus.

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Vaccination Vaccine Immune Response FDA Approval 52

XTalks

MARCH 25, 2021

She also writes informative blogs on topics including drug development, life science company profiles and HR content pertaining to the pharma and biotech industries. Ayesha obtained an MSc in Cancer & Genetics from McMaster University and a PhD in Medical Biophysics from the University of Toronto.

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