Bio Pharma Dive

MARCH 20, 2023

As new gene therapies are developed to treat a growing number of indications, patients may soon have access to novel treatment options and potential cures.

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Gene Therapy Gene Development Manufacturing 245

Bio Pharma Dive

NOVEMBER 13, 2023

Forge Biologics operates a contract manufacturing business as well as develops its own gene therapies, which appears to have attracted the Japan-based food and biotechnology company.

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Gene Therapy Gene Contract Manufacturing Manufacturing 269

Bio Pharma Dive

AUGUST 21, 2023

By partnering with an accomplished CTDMO, gene therapy innovators can benefit from guidance and support.

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Gene Therapy Gene Manufacturing 246

Pharmaceutical Technology

MAY 4, 2023

Forge Biologics and global life sciences company Labcorp have announced a strategic adeno-associated virus (AAV) gene therapy development and manufacturing collaboration. This will improve accessibility to services for AAV-mediated gene therapy programmes.

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Gene Therapy Gene Development Manufacturing 256

Pharmaceutical Technology

MARCH 21, 2024

Panellists discuss opportunities and challenges in cell and gene therapies at the Advanced Therapies conference in London, UK.

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Gene Therapy Gene Manufacturing 130

Bio Pharma Dive

OCTOBER 30, 2020

A longer-than-expected timeline for developing a new manufacturing process means a key study for Axovant's top gene therapy likely won't begin until 2022.

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Gene Therapy Manufacturing Gene Development 275

Fierce Pharma

APRIL 9, 2024

Though gene therapy manufacturing specialist Ascend Advanced Therapies just launched a little more than a year ago, the CDMO is already on the hunt to expand. As part of the deal, Ascend has also agreed to a long-term partnership with Beacon to produce its ocular gene therapies for clinical and commercial use.

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Gene Therapy Gene Manufacturing Development 102

Pharmaceutical Technology

APRIL 25, 2023

Forge Biologics has received a qualified person (QP) declaration to manufacture adeno-associated virus (AAV) gene therapies to support European clinical programmes. The company stated that a European QP has completed an in-depth audit at its manufacturing facility in Columbus, Ohio, US.

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Gene Therapy Gene Manufacturing Production 130

Pharmaceutical Technology

JUNE 29, 2022

Terumo Blood and Cell Technologies and BioBridge Global subsidiary, GenCure, have entered a new partnership agreement to expand and integrate cell and gene therapy manufacturing solutions. In the initial stage, the alliance will use Terumo and GenCure’s capabilities to set up a reference manufacturing centre for BioBridge.

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Gene Therapy Gene Manufacturing Production 264

BioPharma Reporter

FEBRUARY 5, 2024

At Advanced Therapies Week 2024 in Miami, Isabel Cameron hosted a roundtable discussion to discuss all things cell and gene therapy manufacturing.

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Gene Therapy Manufacturing Gene Development 105

pharmaphorum

JANUARY 25, 2024

On today’s podcast, host Jonah Comstock is joined by Arturo Araya, EVP of commercialisation at Cellares, a company that is attempting to create a new kind of contract manufacturing organisation for the rapidly crystalizing world of cell and gene therapy.

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Gene Therapy Manufacturing Gene Contract Manufacturing 111

Pharmaceutical Technology

MAY 24, 2023

Forge Biologics has joined the public-private collaboration, the Bespoke Gene Therapy Consortium (BGTC), to expedite the development and manufacture of new AAV [adeno-associated virus] gene therapies to treat patients with rare diseases. Topic sponsors are not involved in the creation of editorial content.

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Gene Therapy Gene Development Manufacturing 242

Bio Pharma Dive

APRIL 23, 2024

The complete response letter for Abeona’s treatment is one of several manufacturing setbacks for cell and gene therapy developers in recent years.

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Manufacturing Gene Therapy Gene Development 159

Pharmaceutical Technology

OCTOBER 25, 2022

Ast ellas Pharma has announced plans to make a strategic investment to back the development of Taysha Gene Therapies’ adeno-associated virus (AAV) development programmes for Rett syndrome and giant axonal neuropathy (GAN). Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.

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Gene Therapy Gene Development Genetics 264

BioPharma Reporter

APRIL 22, 2024

SK pharmteco has signed an agreement with Ferring Pharmaceuticals, to scale up commercial manufacturing capacity for the drug substance of Ferringâs intravesical gene therapy Adstiladrin.

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Gene Therapy Manufacturing Gene Drugs 59

Pharmaceutical Technology

APRIL 3, 2023

The deal will see Polyplus join the German life science group’s portfolio allowing the latter to leverage expertise in transfection reagents and plasmid DNA for gene therapy. Polyplus, based in Strasbourg, France, produces key components in the production of viral vectors used in cell and gene therapies.

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Gene Therapy Gene DNA Reagent 246

Pharmaceutical Technology

MAY 16, 2023

The Foundation for the National Institutes of Health (FNIH) has announced its plans to prioritise eight rare diseases to provide industry standards for manufacturing, preclinical testing and product analytical testing for gene therapy development.

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Gene Therapy Gene Research Clinical Trials 227

Pharmaceutical Technology

MAY 26, 2023

Krystal Biotech has received approval from the US Food and Drug Administration for topical gene therapy VYJUVEK to treat dystrophic epidermolysis bullosa (DEB) in adults and in children aged six months and above. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.

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Gene Therapy Gene FDA Approval Manufacturing 264

Pharmaceutical Technology

MAY 25, 2023

ElevateBio has raised $401m in a Series D financing round for advancing its technology platforms to expedite the design, production and development of cell and gene therapies. ElevateBio intends to use the funds to advance its genetic medicine current good manufacturing practice (cGMP) and process development business, BaseCamp.

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Gene Therapy Gene Gene Editing Manufacturing 243

BioSpace

MARCH 25, 2024

Brazil’s Ministry of Health and nonprofit Caring Cross announced a collaboration Tuesday aimed at local manufacturing of CAR-T cell and stem cell gene therapies at a much lower cost than Europe and the U.S.

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Gene Therapy Gene Manufacturing 121

pharmaphorum

AUGUST 10, 2023

Manufacturing gene therapies, oncolytic viruses, and vaccine candidates: In conversation with ABL Mike.Hammerton Thu, 10/08/2023 - 08:00 Bookmark this

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Gene Therapy Manufacturing Gene Vaccination 98

BioPharma Reporter

MARCH 19, 2024

Food and Drug Administration has cleared AGC Biologicsâ Milan site to begin manufacturing of Orchard Therapeuticsâ Lenmeldy (atidarsagene autotemcel), a gene therapy for early-onset metachromatic leukodystrophy (MLD).

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Gene Therapy Manufacturing Gene FDA Approval 59

Pharma Mirror

APRIL 28, 2021

Catalent will provide process development and CGMP manufacturing of AavantiBio’s adeno-associated viral (AAV) vector-based therapeutic candidate for use in clinical trials in the U.S. and Europe. Catalent will further support process optimization and look to reduce material.

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Gene Therapy Genetic Disease Genetics Gene 130

Pharmaceutical Technology

JULY 7, 2022

For many decades, investigators have been working on innovative therapeutic modalities known as cell and gene therapies, which use modified versions of the body’s own cellular and genetic material to treat and potentially cure these diseases. A new frontier in cancer research. Securing the supply chain.

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Gene Therapy Gene Medicine Genetics 245

BioSpace

JULY 18, 2023

Next-gen biomanufacturers are particularly susceptible to the challenges inherent in manufacturing cell and gene therapies, risking getting derailed by unexpected costs for already-tight budgets.

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Gene Therapy Manufacturing Gene 98

Bio Pharma Dive

NOVEMBER 5, 2020

The setback for Bluebird's LentiGlobin comes amid a string of manufacturing-related delays for gene therapy developers.

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Gene Therapy Gene Manufacturing Development 318

BioPharma Reporter

JANUARY 10, 2023

Catalent is to support the manufacture of Sarepta Therapeutics' gene therapy candidate for the treatment of Duchenne muscular dystrophy (DMD).

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Gene Therapy Manufacturing Gene Regulation 119

Pharmaceutical Technology

NOVEMBER 9, 2022

On November 2, the Institute for Clinical and Economic Review (ICER) released its updated evidence aimed at measuring the clinical effectiveness and cost of the two haemophilia gene therapies. Known by the brand name Roctavian, BioMarin’s haemophilia A therapy valoctocogene roxaparvovec could be fairly priced in the range of $1.95–1.96

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Gene Therapy Gene FDA Approval Medicine 278

Fierce Pharma

SEPTEMBER 28, 2023

As bluebird bio’s pricey gene therapy launches take flight, the company is boosting manufacturing capacity with Swiss CDMO Lonza. Under the updated deal, Lonza has agreed to increase manufacturing capacity for bluebird’s therapies Zynteglo and Skysona, according to a SEC filing published Wednesday.

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Gene Therapy Manufacturing Gene Production 94

Bio Pharma Dive

AUGUST 25, 2022

The biotech signed a 30-year deal with the University of Pittsburgh to establish a gene and cell therapy manufacturing hub that’s being built with a $100 million grant.

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Manufacturing Gene Gene Therapy 262

BioPharma Reporter

NOVEMBER 7, 2022

Charles River Laboratoriesâ growing gene therapy manufacturing capabilities have landed it a deal with the eye disease biotech Nanoscope Therapeutics.

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Gene Therapy Manufacturing Gene Clinical Development 98

Bio Pharma Dive

JUNE 20, 2023

Joining larger CDMOs like Lonza and Catalent, a new group of companies aims to capitalize on persistent bottlenecks in producing complex genetic treatments.

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Gene Therapy Manufacturing Gene Genetics 268

BioPharma Reporter

JUNE 29, 2023

Astraveus, the creator of modular, microfluidic cell foundries for cell and gene therapy (CGT) manufacturing, has raised â16.5 million in series seed financing.

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Gene Therapy Manufacturing Gene Regulation 90

Drug Discovery World

SEPTEMBER 5, 2023

In the eleventh eBook of the Hamilton series ‘Analytical Methods for Viral Vector Development and Manufacturing in Gene Therapy’, we learn about: Gene therapy: history, viral vectors and the role of CDMOs Automation of analytical assays during viral vector development and manufacturing The solutions that Hamilton offers to customers working (..)

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Gene Therapy Manufacturing Gene Development 52

Fierce Pharma

MARCH 14, 2024

After charting multiple personalized medicine expansions in recent years, contract manufacturer Charles River Laboratories is back with another gene therapy pact—this time centered on an adeno-asso | After charting multiple personalized medicine expansions in recent years, contract manufacturer Charles River Laboratories is back with another gene therapy (..)

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Gene Therapy Contract Manufacturing Gene Production 94

Bio Pharma Dive

APRIL 11, 2023

Founded by University of Pennsylvania researchers, VintaBio will manufacture the viral vectors that are essential in cell and gene therapy production, but which have been in shorter supply as more companies entered the space.

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Gene Therapy Gene Production Manufacturing 152

Pharmaceutical Technology

DECEMBER 14, 2022

Merck and Synplogen have signed a non-binding Memorandum of Understanding (MoU) to expedite the development and manufacturing of viral vector-based gene therapy applications. The firms intend to merge their expertise to provide simplified viral vector gene therapy development, production and testing in Japan.

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Gene Therapy Gene Development Manufacturing 130