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 (..)

Gene Therapy 85

Gene Therapy Contract Manufacturing Gene Production 85

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. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.

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Gene Therapy Gene Development Manufacturing 242

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.

Gene Therapy 243

Gene Therapy Gene Gene Editing Manufacturing 243

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

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.

Gene Therapy 130

Gene Therapy Genetic Disease Genetics Gene 130

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. Bluebird and Lonza recently amended their production contract for the second time since the deal was announced in summer of 2016.

Gene Therapy 84

Gene Therapy Manufacturing Gene Production 84

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

Pharma Mirror

JANUARY 24, 2023

Science-based innovation for manufacturing high quality cells challenges dogma and terminology Cell and gene therapies are dominating the world of drug development. billion by 2026, up from $186 billion in 2019 according to the Evaluate Pharma report.

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Production Gene Therapy Manufacturing Gene 130

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.

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DNA Manufacturing Gene Therapy Production 75

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.

Gene Therapy 130

Gene Therapy Gene Development Manufacturing 130

BioPharma Reporter

SEPTEMBER 19, 2023

The contract development and manufacturing organization (CDMO) Fujifilm Diosynth Biotechnologies has completed a UK manufacturing facility for the production of advanced therapies including viral gene therapies, oncolytic viruses and viral vaccines for use in clinical trials.

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Manufacturing Gene Therapy Clinical Trials Clinical Trials 98

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

Pharmaceutical Technology

FEBRUARY 8, 2023

Genenta Science and AGC Biologics have signed a development and manufacturing service agreement (MSA). Under the deal, AGC Biologics will be responsible for manufacturing the cell therapy lentivirus-based product for the ongoing clinical programmes of Genenta Science.

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Manufacturing Gene Therapy Production Clinical Trials 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

Pharmaceutical Technology

JUNE 9, 2023

The US Food and Drug Administration (FDA) has granted approval to commence commercial production at Bristol Myers Squibb’s new advanced cell therapy manufacturing facility in Devens, Massachusetts. The site has been involved in the development, manufacture and testing of clinical and commercial medicines.

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FDA Approval Production Gene Therapy Manufacturing 130

Pharmaceutical Technology

AUGUST 25, 2022

Sonoma Biotherapeutics has signed a lease agreement for setting up an 83,000ft² research and development (R&D) and manufacturing centre for cell therapies. A cGMP-compliant production facility will be housed at the centre for manufacturing cell products at scale.

Manufacturing 130

Manufacturing Engineer Gene Therapy Production 130

BioPharma Reporter

MARCH 14, 2023

The new Clinical Biotechnology Centre (CBC) in Bristol will expand the UKâs ability to make clinical grade products for the research and development of new cell and gene therapies.

Gene Therapy 98

Gene Therapy Gene Manufacturing Production 98

Pharmaceutical Technology

JUNE 8, 2023

Mendus has entered an alliance with NorthX Biologics to co-establish a cell therapy manufacturing unit for its lead asset, vididencel, in Sweden. Mendus has partnered with NorthX and Swedish investment firm Flerie Invest, which will make an initial investment of Skr90m ($8.25m) in the manufacturing unit.

Manufacturing 130

Manufacturing Gene Therapy Gene Clinical Trials 130

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. Pharma manufacturing facilities in Andhra Pradesh and Telangana accounted for 22.5% © GlobalData. © GlobalData. ©GlobalData.

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Manufacturing Generic Drugs Contract Manufacturing Production 130

Pharmaceutical Technology

AUGUST 17, 2022

Biopharmaceutical contract development and manufacturing organisation (CDMO) AGC Biologics has entered a strategic collaboration with RoosterBio to expedite the manufacturing of cell and exosome therapies. It will also have the potential to scale to Phase III clinical development and commercial manufacturing.

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Manufacturing Gene Therapy Genetic Engineering Gene 130

Pharmaceutical Technology

APRIL 27, 2023

Bristol Myers Squibb will take over a former Novartis plant to boost viral vector production for chimeric antigen receptor (CAR) T-cell therapies. Bristol Myers Squibb stated that the facility will provide viral vector production capabilities for its two CAR T-cell therapies.

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Production Gene Therapy Manufacturing Engineer 130

Pharmaceutical Technology

OCTOBER 14, 2022

Pharmaceutical companies Xcell Biosciences (Xcellbio) and aCGT Vector have partnered to expedite the development of cell and gene therapies. The two companies will aim to improve the manufacturing and analytic procedures used to develop personalised cell and gene therapies to treat cancer patients.

Gene Therapy 130

Gene Therapy Gene Development Manufacturing 130

BioPharma Reporter

AUGUST 10, 2023

AGC Biologics, a global contract development and manufacturing organization (CDMO), has completed the expansion of its manufacturing space at its Milan Cell and Gene Center of Excellence production site.

Gene Therapy 98

Gene Therapy Gene Manufacturing Production 98

XTalks

JUNE 12, 2023

Bristol Myers Squibb (BMS), a multinational pharmaceutical company based in New York City, has announced that its new state-of-the-art cell therapy manufacturing facility in Devens, Massachusetts, has received approval for commercial production from the US Food and Drug Administration (FDA).

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Manufacturing Gene Therapy FDA Approval Gene 95

XTalks

JUNE 8, 2023

Over the past few years, there has been a significant expansion in the cell and gene therapy landscape, with an increasing number of therapies entering clinical trials and receiving regulatory approvals. “I think if we all go into these relationships with this mindset, we’ll achieve great things together.”

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Gene Therapy Gene Production Development 98

Pharma Mirror

FEBRUARY 23, 2021

Catalent is also announcing the launch of pDNA development and manufacturing services at its Rockville, Maryland facility. Together, the addition of pDNA technology and production capabilities. The post Catalent to Acquire Delphi Genetics and Launch US Plasmid Manufacturing Site appeared first on Pharma Mirror Magazine.

Genetics 130

Genetics Manufacturing Gene Therapy DNA 130

BioPharma Reporter

SEPTEMBER 28, 2021

has opened a manufacturing facility at the Phase II Suzhou Biomedical Industrial Park (BioBAY) in Suzhou, China. Neurophth Biotechnology Ltd.

Manufacturing 105

Manufacturing Gene Therapy Production Gene 105

Pharmaceutical Technology

JUNE 8, 2023

GenScript ProBio has collaborated with the New York Blood Center Enterprises’ business unit, called Comprehensive Cell Solutions (CCS), to accelerate the development and manufacture of cell and gene therapies. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.

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Gene Therapy Gene Development Antibody 130

Camargo

DECEMBER 20, 2021

Many of the advancements included in PDUFA VII are driven in large part by an increase in the development of innovative products such as cell and gene therapies. The increase is designed to strengthen CBER’s capacity and capabilities for regulating cell and gene therapies. Enhancing Product Quality Reviews.

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Gene Therapy Gene Development Production 184

Pharmaceutical Technology

NOVEMBER 21, 2022

RVAC Medicines has signed a master research partnership agreement with the Agency for Science, Technology and Research (A*STAR) for analysing and developing solutions to build messenger ribonucleic acid (mRNA) manufacturing and analytics expertise in Singapore. Topic sponsors are not involved in the creation of editorial content.

Manufacturing 130

Manufacturing Medicine Vaccination Vaccine 130

Pharmaceutical Technology

JUNE 2, 2023

Rentschler Biopharma has collaborated with Ikarovec for expediting the new gene therapies to treat ophthalmic disease. The company is developing new and differentiated gene therapies for the treatment of serious, but common eye diseases. Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.

Gene Therapy 130

Gene Therapy Gene Clinical Supply Manufacturing 130

Pharmaceutical Technology

JUNE 19, 2023

Although only a small number of gene therapies have reached the market thus far, the industry is poised to grow quickly over the next few years. According to GlobalData’s clinical trials database, there are currently 1,231 planned and ongoing trials for gene therapies and gene-modified cell therapies alone.

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Gene Therapy Gene Packaging Packaging 130

Pharmaceutical Technology

JANUARY 20, 2023

Bancel explained that this deal will “shrink the time to get from designing the sequence to having products ready by two more weeks”. Increasing manufacturing capacity for pandemic prevention “The other piece we are working on is … how do we build manufacturing capacity around the world?”, said Bancel. said Bancel.

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Manufacturing Vaccination Vaccine Gene Therapy 246

Drug Discovery World

MAY 7, 2024

Where the bottlenecks of achieving higher cell density and higher titers were once thought to be issues of the past, hurdles have now shifted to achieving speed and scale in mAb production without sacrificing quality. DC: Antibodies have and remain a large product class within the biopharmaceutical market.

Antibody 59

Antibody Production Manufacturing Engineer 59

Roots Analysis

FEBRUARY 27, 2024

Over the last few decades, various viral vector manufacturing have been developed, optimized and standardized for introduction of therapeutic DNA / gene of interest into a patient’s body / cells. On the other hand, among non-viral gene delivery tools, plasmid DNA has emerged as the preferred option.

Manufacturing 52

Manufacturing Gene Therapy Gene DNA 52

Pharmaceutical Technology

FEBRUARY 23, 2023

Moderna has entered a strategic research and development partnership with ElevateBio’s Life Edit Therapeutics to discover and develop new in-vivo mRNA gene editing therapies. Moderna will also assume further development, manufacturing, and commercialisation responsibilities on exercising a target option.

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Gene Editing Gene In-Vivo Gene Therapy 147