BioSpace

OCTOBER 25, 2021

10X Genomics is continuing to increase its presence outside of the United States, this time with its first manufacturing facility outside of the country.

Genome 78

Genome Genomics Manufacturing 78

Pharmaceutical Technology

OCTOBER 6, 2023

Genomics company Twist Bioscience has entered into an antibody discovery, option and licence agreement with German drug manufacturer Bayer.

Antibody 130

Antibody Genome Genomics Manufacturing 130

Pharmaceutical Technology

MARCH 8, 2023

Global science and technology innovator Danaher has entered a strategic collaboration with the University of Pennsylvania for cellular immunotherapies to address manufacturing challenges impacting cell therapy uptake. The new technologies will also overcome the manufacturing bottlenecks in delivering advanced engineered cell products.

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Gene Therapy Manufacturing Gene Production 244

BioPharma Reporter

NOVEMBER 10, 2021

The company recently opened a manufacturing and commercial hub in Singapore, making the facility its first outside of the US.

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Genome Genomics Manufacturing Regulation 92

XTalks

MARCH 21, 2025

At the same time, the company has plans to expand US manufacturing investments to meet rising demand across its growing pipeline, creating around 13,000 jobs. Iovance reported Q4 2024 revenue of $10 million and plans to expand manufacturing capacity in Philadelphia to meet growing demand and support additional solid tumor indications.

Genome 59

Genome Genomics FDA Approval Trials 59

World of DTC Marketing

DECEMBER 29, 2020

Both the Pfizer and Moderna vaccines copied RNA sequence from the virus genome and found a way to manufacture it at scale with high-level processes and quality control. First, a novel approach was used that didn’t require traditional vaccine production in cell cultures or eggs. 1455NO-HEALTH-CORONAVIRUS_VACCINES_PFIZER_O_.

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Vaccination Vaccine Development Clinical Trials 307

pharmaphorum

JANUARY 29, 2021

Genome editing is an exciting but still nascent field, and companies in the area face as many obstacles as they do opportunities. It has also built its own manufacturing site and launched partnerships with six big pharma companies. The genomic medicine journey. billion in funding.

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Gene Editing Gene Gene Therapy In-Vivo 145

XTalks

JANUARY 21, 2025

TriClip G4 System Manufacturer/developer : Abbott Medical Date of FDA approval : April 1, 2024 Approved for : Tricuspid regurgitation (TR). Abbott Spinal Cord Stimulation (SCS) Systems Manufacturer/developer : Abbott Medical Date of FDA approval : May 30, 2024 Approved for : Chronic, hard-to-manage pain in the torso, arms and legs.

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FDA Approval Manufacturing Development RNA 105

STAT News

FEBRUARY 22, 2023

Life Edit is the North Carolina subsidiary of ElevateBio, a cell and gene therapy manufacturing firm in Waltham. Moderna will fund preclinical research studies run by the two companies using Life Edit’s tools based on CRISPR technologies that allow scientists to make precise changes to the human genome.

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Gene Editing Gene Genetic Disease Research 126

Pharmaceutical Technology

JULY 29, 2022

In preparation for this, drug manufacturing will begin later this year and will be outsourced to external contract manufacturing organisations (CMOs). According to Bumcrot, regRNAs are “RNAs that arise out of the non-coding genome”. A nitrogen-binding drug, its global sales were $292m in 2021, as per GlobalData.

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RNA Gene Expression Gene Gene Therapy 245

XTalks

MARCH 13, 2025

In 2024, GRAIL reduced its workforce by 30% as part of a corporate restructuring to focus on its core multi-cancer early detection business, while BD (Becton Dickinson) cut 200 jobs at its Israeli manufacturing plant amid efforts to streamline operations.

Genome 66

Genome Genomics Marketing Manufacturing 66

XTalks

MARCH 10, 2022

As the leader in genomic sequencing, Clear Labs helps its clients better understand and manage pathogens, from foodborne illnesses to SARS-CoV2. Traditional food safety testing methods used in manufacturing facilities are inconsistent, time consuming and often require trained technicians. You find a positive case in your plant.

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Manufacturing Genome Genomics Contamination 98

Pharmaceutical Technology

OCTOBER 26, 2022

New doors were opened in the 2000s with the development of genome editing, such as CRISPR-Cas9, which introduces molecular tools to change existing DNA. Collaboration and integrated manufacturing. Streamlined clinical trial design with integrated manufacturing can ensure that gene and cell therapies are developed much faster.

Gene Therapy 130

Gene Therapy Gene Marketing Manufacturing 130

XTalks

JULY 3, 2024

Genome Editing in Plants The FDA has also released guidance for foods derived from plants produced using genome editing. This guidance aims to address the regulatory framework and safety assessments for genome-edited plant foods, providing clarity for industry participants involved in developing these innovative products.

Genome 105

Genome Genomics Production Regulation 105

The Pharma Data

OCTOBER 26, 2021

The AVENIO Tumor Tissue Comprehensive Genomic Profiling (CGP) Kit is the first jointly-developed product that brings together the expertise and reach of Roche with Foundation Medicine’s pioneering leadership in genomic science. Cancer is a disease of the genome and treatment no longer depends solely on the tissue of origin.

Genome 52

Genome Genomics Research Medicine 52

BioTech 365

AUGUST 17, 2021

ERS Genomics and Cellular Engineering Technologies Enter CRISPR/Cas9 License Agreement ERS Genomics and Cellular Engineering Technologies Enter CRISPR/Cas9 License Agreement License allows Cellular Engineering Technologies to develop, manufacture and commercialize next generation stem cell lines using CRISPR/Cas9 technology DUBLIN & … Continue (..)

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Engineer Genome Genomics Licensing 40

Pharmaceutical Technology

FEBRUARY 23, 2023

Moderna will also assume further development, manufacturing, and commercialisation responsibilities on exercising a target option. The company’s nuclease collection includes several Protospacer Adjacent Motifs (PAMs), short sequences that help determine the genome’s DNA segments.

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Gene Editing Gene In-Vivo Gene Therapy 147

Pharmaceutical Technology

FEBRUARY 15, 2023

But the mRNA technology is not yet mature and there are no standardised manufacturing protocols yet. Some of the variables include the chemical composition of the LNP, the manufacturing process and of course the RNA itself, whose design and production must elicit the intended therapeutic outcome.” weight abundance.

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Bioassay RNA Development Drugs 130

Pharmaceutical Technology

JUNE 24, 2022

The EMA stated that the agency will initially focus on the chemistry, manufacturing and controls (CMC) data for the component targeting Omicron subvariants. Given SARS-CoV-2’s ability to mutate and change its genome, it is hard to say what will be the future variants of the virus. Omicron subvariants dominate.

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Vaccination Vaccine Antibody Medicine 264

XTalks

AUGUST 29, 2022

CRISPR is notable for engineering living cells, allowing scientists to edit, turn off, delete, or replace genes in a cell’s genome. It is difficult to control where the viral vectors insert genes in the genome, and it is difficult to manufacture large quantities of clinical-grade viral vectors.

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Gene Editing DNA Gene Genome 98

Pharmaceutical Technology

DECEMBER 9, 2022

Solvias is a Swiss-based pharmaceutical company focused on contract research, development and manufacturing. In regards to the latter, notable examples include the acquisition of Cergentis, a genomics-focused biotechnology company based in the Netherlands. Pharmaceutical Technology Excellence Rankings – The Verdict.

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Development Production Manufacturing Vaccine 130

BioPharma Reporter

APRIL 16, 2024

Cytiva has announced the launch of its Xcellerex magnetic mixer â a single-use mixing system designed to address challenges faced by customers engaged in large-scale mAb, vaccine and genomic medicine manufacturing processes.

Genome 52

Genome Genomics Manufacturing Vaccination 52

pharmaphorum

JANUARY 5, 2023

and OriCiro Genomics K.K. Stéphane Bancel, chief executive officer at Moderna, said: “With this acquisition, we obtain best-in-class tools for cell-free synthesis and amplification of plasmid DNA, a key building block in mRNA manufacturing.”. Biotech Moderna, Inc. The deal marks 10-year-old Moderna’s first acquisition.

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Gene Sequencing DNA Vaccination Vaccine 97

pharmaphorum

OCTOBER 4, 2022

AstraZeneca’s rare disease firm Alexion is set to expand its genomic medicine portfolio with the acquisition of gene editing specialist LogicBio Therapeutics, in a deal worth approximately $68 million. As per the agreement, Alexion will initiate a cash tender offer through a subsidiary to acquire all outstanding shares of LogicBio for $2.07

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Gene Editing Gene Genome Genomics 64

XTalks

OCTOBER 8, 2020

Aizon is well positioned to help those manufacturing sectors meet stringent regulatory requirements and extract deeper understanding of complex processes, which ultimately leads to new sources of value,” said John Vitalie, chief executive officer of Aizon, in the press statement from the company.

Manufacturing 98

Manufacturing Life Science Cosmetics Regulation 98

pharmaphorum

JUNE 23, 2022

The deal comes a year after Intellia and partner Regeneron reported promising results from the first clinical trial of a drug used to edit the genomes of cells within the body, in patients with rare disease ATTR amyloidosis. billion in potential milestones if the project advances through development and onto the market.

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Gene Editing In-Vivo Gene Sequencing Gene 97

FDA Law Blog

MARCH 3, 2024

Biotechnology companies of concern include BGI (formerly Beijing Genomics Institute), MGI, Complete Genomics, WuXi Apptec, and any subsidiary, parent, affiliate, or successor of such entities. Office of Management and Budget (OMB) can also specify other equipment or services to be subject to the Act’s prohibitions.

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Genome Genomics Manufacturing Production 102

The Pharma Data

DECEMBER 17, 2020

Klisyri will be manufactured by Athenex. The week began with big news from the field of genomics, as the FDA on Monday approved a first-of-its-kind intentional genomic alteration (IGA) in pigs that could reduce potential allergic reactions when porcine materials are used for medical purposes in humans.

FDA Approval 52

FDA Approval Genome Genomics Production 52

pharmaphorum

JANUARY 6, 2023

BioNTech gets the opportunity to tap into the NHS as a source of subjects for its cancer vaccine studies, as well as access to genomics and health data resources, and in return will open an R&D centre in Cambridge, employing more than 70 scientists, as well as an office in London.

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Clinical Trials Clinical Trials Trials Vaccination 111

pharmaphorum

FEBRUARY 3, 2021

The paradigm of patient-derived autologous CAR-T cell production hinders controllable or scalable manufacturing and on-time treatment for patients. Multiple break points in the genome might not only trigger a DNA damage response and cell death but could also generate translocations and chromosomal rearrangements.

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Gene Editing Gene DNA Engineer 98

Pharmaceutical Technology

AUGUST 26, 2008

As understanding of biological systems has forged ahead, pharmaceutical companies have made increasing use of biotechnology in discovering and manufacturing new medicines. It was once derided as the stuff of science fiction, but in recent years, biotechnology has emerged as an important growth area in pharmaceuticals.

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Antibody Licensing Licensing Production 100

Intouch Solutions

NOVEMBER 20, 2023

This tailored, local approach to treatment, when blended with the wonders of cutting-edge testing and genomics, is poised to be a game-changer, promising not only better patient outcomes but also improved resource efficiency. Market Access will prioritize Health Equity: Healthcare remains a locally delivered and consumed good!

Marketing 105

Marketing Manufacturing Genome Genomics 105

pharmaphorum

MAY 23, 2022

That includes health, clinical and MRI imaging data as well as genomic information, and the project could be useful in the discovery of new medicines and medical technologies, according to a joint statement.

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Big Data Genome Genomics Development 90

pharmaphorum

NOVEMBER 28, 2021

1.1.529 variant of COVID-19 – now christened Omicron – leading vaccine manufacturers have said they are poised to develop new shots if needed. Other vaccine manufacturers have also responded to the new variant. With governments around the world announcing measures to curb the new B.1.1.529

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Vaccination Vaccine Protein Genetics 111

Pharmaceutical Technology

DECEMBER 22, 2022

This can include changes to materials and manufacturing, supply chain reviews; reduction in energy use or switches to renewables; recycling initiatives; and carbon offsetting. We are specifically looking at novelty, including companies launching products into new areas or innovation in the product’s design, manufacture or marketing.

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Insulin Production Development Genetics 130

pharmaphorum

NOVEMBER 12, 2020

In 2018, it bought Element Genomics – a spin-out of Duke University in the US – to add genome-editing technologies, and has also been growing its internal exercise at its Boston R&D hub, although so far it hasn’t advanced and gene therapies into clinical development.

Gene Therapy 52

Gene Therapy Gene Manufacturing Contract Manufacturing 52

The Pharma Data

OCTOBER 27, 2020

.” The single-reaction panel targets five regions of the viral genome and provides excellent accuracy and sensitivity. “Most real time qPCR-based assays target only two or three targets on the viral genome.” “Most real time qPCR-based assays target only two or three targets on the viral genome.”

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Genetic Analysis Genome Genomics Reagent 52