BioPharma Reporter

MAY 10, 2022

Regenxbio says it is to delay dosing of patients in its DMD gene therapy clinical trial following a quality issue at an unnamed third-party contract manufacturer.

Contract Manufacturing 52

Contract Manufacturing Gene Therapy Manufacturing Gene 52

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). The most common marketed drugs in this space aim to address the hyperammonaemia caused by the defective genes in this disorder.

RNA 245

RNA Gene Expression Gene Gene Therapy 245

Pharmaceutical Technology

NOVEMBER 22, 2022

Despite China producing a significant proportion of the world’s API supply (mostly small molecule), it manufactures relatively few biosimilar and innovator drugs and no cell and gene therapies for the western markets of Europe and the US despite investments and an increasing number of startups to improve innovative manufacture.

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Manufacturing Gene Therapy Gene Contract Manufacturing 162

Pharma Mirror

MARCH 31, 2022

Symbiosis Pharmaceutical Services Ltd (Symbiosis), a fast-growing contract manufacturing organisation (CMO) specialising in sterile global manufacture of pharmaceuticals, vaccines and biopharmaceuticals including Advanced Therapeutical Medicinal Products (ATMPs), has announced the completion of a £1.3

Manufacturing 130

Manufacturing Contract Manufacturing Gene Therapy Research 130

Fierce Pharma

JUNE 3, 2024

As Japanese chemical giant Asahi Kasei continues its foray into the biopharma contract manufacturing space, the company’s biologics CDMO is expanding its offerings to include starting materials for | Asahi’s U.S.

DNA 80

DNA Gene Therapy Contract Manufacturing Gene 80

Fierce Pharma

OCTOBER 31, 2023

Even as Catalent dusts itself off from a pandemic sales plunge, the company may be teetering on the edge of another contract manufacturing precipice.

Gene Therapy 59

Gene Therapy Gene Contract Manufacturing Trials 59

Pharmaceutical Technology

AUGUST 16, 2022

Large (market cap $10–100bn) and mega-cap (market cap >$100bn) sponsors also require contract manufacturers and packagers with specialist injectable capabilities in the case of cell and gene therapies, as shown in the report titled Contract Injectable Packaging Trends in the Bio/Pharma Industry (August 2022).

Gene Therapy 162

Gene Therapy Packaging Packaging Contract Packaging 162

pharmaphorum

NOVEMBER 12, 2020

UCB has made a new foray into the gene therapy space, buying fellow Belgium-based company Handl to get control of its adeno-associated virus (AAV) capsid delivery platform and two research programmes in neurodegenerative diseases. The post UCB revs up its gene therapy drive with Handl acquisition appeared first on.

Gene Therapy 52

Gene Therapy Gene Manufacturing Contract Manufacturing 52

BioTech 365

MAY 27, 2021

Gene Therapies, Cell Therapies, and COVID-19 Vaccines Viral Vector Contract Manufacturing Outlook Report 2021: Spotlight on AstraZeneca’s COVID-19 Vaccine, Luxturna, Zolgensma, Emergent, Catalent – ResearchAndMarkets.com Gene Therapies, Cell Therapies, and COVID-19 Vaccines Viral Vector Contract Manufacturing Outlook Report 2021: Spotlight (..)

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Contract Manufacturing Gene Therapy Vaccination Vaccine 40

BioPharma Reporter

JULY 18, 2024

Contract development and manufacturing organizations (CDMOs) perform vital services for the biopharmaceutical industry â a role that is growing as cell and gene therapies gain momentum. Here are five of the top CDMOs bringing advanced therapies toward the market.

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Gene Therapy Marketing Manufacturing Gene 98

Roots Analysis

AUGUST 29, 2023

In this context, it is worth highlighting those 14 biopharmaceutical products ( including cell therapies, gene therapies, monoclonal antibodies and recombinant proteins ) were approved in the US alone, in 2021. As a result, biopharmaceutical contract manufacturing has picked up pace in the recent years.

Contract Manufacturing 40

Contract Manufacturing Manufacturing Gene Therapy Marketing 40

Roots Analysis

AUGUST 29, 2023

In this context, it is worth highlighting those 14 biopharmaceutical products ( including cell therapies, gene therapies, monoclonal antibodies and recombinant proteins ) were approved in the US alone, in 2021. As a result, biopharmaceutical contract manufacturing has picked up pace in the recent years.

Contract Manufacturing 40

Contract Manufacturing Manufacturing Gene Therapy Marketing 40

BioPharma Reporter

DECEMBER 9, 2021

Taiwan based contract manufacturer, Bora Pharmaceuticals, in partnership with Taishin Healthcare Limited, is ready to spend millions to expand its footprint in the CDMO sector.

Contract Manufacturing 52

Contract Manufacturing Gene Therapy Gene Manufacturing 52

BioPharma Reporter

OCTOBER 20, 2022

Forge Biologics has added plasmid DNA manufacturing to its roster of services, enabling it to vertically integrate its production process.

DNA 73

DNA Manufacturing Gene Therapy Production 73

Fierce Pharma

MAY 25, 2023

As drugmakers advance a wave of new cell and gene therapies, contract manufacturers have captured a larger share of the biopharma spotlight in recent years as they push to meet ever-increasing dema | As drugmakers advance a wave of new cell and gene therapies, contract manufacturers have captured a larger share of the biopharma spotlight in recent (..)

Contract Manufacturing 52

Contract Manufacturing Gene Therapy Gene Manufacturing 52

BioPharma Reporter

APRIL 10, 2024

Patrick Thiaville is chief scientific officer of Exothera Nucleic Acids, a viral vector CDMO (contract manufacturing and development organization) using standard and innovative bioproduction platforms to rapidly deliver affordable viral vector-based vaccines and cell and gene therapies.

Contract Manufacturing 52

Contract Manufacturing Gene Therapy Gene Manufacturing 52

BioPharma Reporter

MAY 15, 2024

Before the industry is set to arrive in San Diego for Bio International 2024, we spoke with Dr. Harald Oberegger, global head business development at Novartis Contract Manufacturing.

Manufacturing 52

Manufacturing Contract Manufacturing Gene Therapy Business Development 52

Pharmaceutical Technology

APRIL 4, 2023

Indian pharma manufacturing continues to be the backbone of drug supplies worldwide, and GlobalData analysis suggests US overreliance on the country for generic drug supply. Telangana’s pharma manufacturing industry is well established and continues to have more than double the pharma sites of Andhra Pradesh. © GlobalData.

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Manufacturing Generic Drugs Contract Manufacturing Production 130

Drug Discovery Today

OCTOBER 19, 2020

Former Lonza President of Biologics Manufacturing joins to continue rapid expansion of DNA contract manufacturing; Touchlight’s synthetic dbDNA in high demand as starting material in the manufacture of advanced therapies such as mRNA vaccines and cell and gene therapies

DNA 45

DNA Contract Manufacturing Gene Therapy Manufacturing 45

Pharmaceutical Technology

MAY 26, 2023

The acquisition targets had a wide variety of manufacturing services, including API and dose manufacturing, packaging, and analytical services. These acquisitions focused on advanced cell and gene therapy capabilities.

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Life Science Manufacturing Contract Manufacturing Gene Therapy 130

BioTech 365

APRIL 22, 2021

Forge Biologics to Present at Chardan’s 5th Annual Genetic Medicines Manufacturing Summit Forge Biologics to Present at Chardan’s 5th Annual Genetic Medicines Manufacturing Summit COLUMBUS, Ohio–(BUSINESS WIRE)–Forge Biologics, a hybrid gene therapy contract manufacturing and clinical stage therapeutic development company, … Continue (..)

Genetics 40

Genetics Manufacturing Medicine Contract Manufacturing 40

Pharmaceutical Technology

JUNE 14, 2023

Future waves of approvals for ATMPs (advanced therapy medicinal products, e.g., cell and gene therapies) will heighten demand on the contract packaging industry, further increasing the need for advanced cold chain solutions and specialized packaging designed to withstand cryogenic temperatures.

Contract Packaging 130

Contract Packaging Packaging Packaging Development 130

Pharmaceutical Technology

JULY 29, 2022

Pfizer (New York, New York) and Moderna’s (Cambridge, Massachusetts) Omicron-specific Covid-19 vaccines are in late-stage development, have demonstrated good efficacy against the variant and will likely be available to the public later this year to provide an additional booster and increase demand for injectable manufacturing.

Manufacturing 130

Manufacturing Vaccination Vaccine Packaging 130

Roots Analysis

FEBRUARY 21, 2022

Since the introduction of a gene sequencing method by Frederick Sanger in 1977, the field of genomic data collection and analysis has evolved significantly. The evolution of NGS technologies has made it possible to sequence thousands of genes with a suspected genetic disease predisposition, in a very short period of time and at minimal costs.

Marketing 52

Marketing Gene Sequencing DNA Genome 52

Roots Analysis

JANUARY 14, 2024

Usually, the desired gene, such as human insulin gene, when inserted into the plasmid of the host cell uses transcriptional and translational machinery of the host to express itself. It is worth mentioning that in vitro gene expression requires a suitable host for the production of a specific gene product.

Contract Manufacturing 40

Contract Manufacturing Protein Manufacturing Production 40

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.

Manufacturing 40

Manufacturing Production Contract Manufacturing Contamination 40

Roots Analysis

MARCH 9, 2022

In the last decade alone, the annual number of approvals of biopharmaceuticals (including monoclonal antibodies, recombinant proteins, vaccines, and gene therapies), by the US FDA, have steadily risen. Biopharmaceutical Excipient Manufacturing Market.

Manufacturing 52

Manufacturing Marketing Contract Manufacturing Protein 52

Roots Analysis

MARCH 13, 2022

In the last decade alone, the annual number of approvals of biopharmaceuticals (including monoclonal antibodies, recombinant proteins, vaccines and gene therapies), by the US FDA, have steadily risen. Over the years, the rising popularity of biologics has led to a paradigm shift in the healthcare industry.

Manufacturing 52

Manufacturing Drug Delivery Marketing Drug Delivery Systems 52

Roots Analysis

AUGUST 8, 2023

Disposable bioreactors have transformed the process of conventional biomanufacturing, and their adoption is increasing rapidly for production of various biologics, such as antibody, recombinant proteins, cell and gene therapy.

Manufacturing 52

Manufacturing Production Marketing Gene Therapy 52

Roots Analysis

OCTOBER 3, 2023

Key Trends that are Shaping up the Global Bioreactors and Fermenters Market As per a recent market report by Roots Analysis, more than 255+ companies are currently involved in manufacturing bioreactors and fermenters, across the globe for the production of biopharmaceuticals, such as antibodies, vaccines, cell and gene therapies.

Vaccination 40

Vaccination Vaccine Production Manufacturing 40

XTalks

FEBRUARY 27, 2024

The company expects the average manufacturing turnaround time to be 34 days, which is from when a tumor sample reaches the manufacturing facility to final release of the product, but without taking into account delivery times.

FDA Approval 52

FDA Approval Manufacturing In-Vivo Trials 52

XTalks

APRIL 11, 2024

In last month’s call, Legend CEO Ying Huang, PhD, shared that the partners are aiming to increase manufacturing capacity at their New Jersey plant. 2seventy has been used to the struggles ever since it spun out of gene therapy biotech bluebird bio. In addition, the companies are also gunning for a first-line setting approval.

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FDA Approval Manufacturing Trials Clinical Trials 52

Pharmaceutical Technology

APRIL 24, 2023

Biologics are costly to produce and sell, and the more recent modalities, such as cell and gene therapies, can be difficult to manufacture. There are fewer sites for cell and gene therapies and vaccines – 90 companies with 127 facilities, as per GlobalData figures.

Contract Manufacturing 130

Contract Manufacturing Manufacturing Protein Sales 130

Pharmaceutical Technology

OCTOBER 27, 2022

There are already nine Chinese-based companies with 14 US contract manufacturing facilities. These capabilities include cell and gene therapies, which China would like to develop to move away from its current focus on high-volume, low-value (often generic) API small molecule manufacture.

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Manufacturing Contract Manufacturing Gene Therapy Gene 267