Clinical Supply and Gene - Clinical Research Informer

Catalent Adds New Cryogenic Capabilities at Shiga, Japan, Facility to Support Clinical Supply Demand for Cell and Gene Therapy Development

The Pharma Data

MAY 26, 2023

The expansion forms part of Catalent’s ongoing global strategy to increase its ability to handle, store and manage advanced therapies for clinical supply, and follows investments at its facilities in Philadelphia, Singapore, and Shanghai, China, in specialized, ultra-low temperature storage capabilities. With sites in the U.S.,

Clinical Supply

Clinical Supply Gene Therapy Gene Development

Rentschler Biopharma and Ikarovec partner to expedite new gene therapies

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

Gene Therapy Gene Clinical Supply Manufacturing

Sharp completes new gene therapy packaging and distribution capacity in The Netherlands

BioPharma Reporter

JANUARY 26, 2022

Contract packaging and clinical supply services company Sharp has completed the construction of new purpose-built production suites to facilitate the packaging, storage and distribution of gene therapies at its facility in Heerenveen, The Netherlands.

Gene Therapy

Gene Therapy Packaging Packaging Contract Packaging

Why demand is rising for secure and climate-controlled gene therapy services

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.

Gene Therapy

Gene Therapy Gene Packaging Packaging

Catalent looks to meet needs of expanding CGT market, completes expansion work at biologics drug substance facility

BioPharma Reporter

APRIL 27, 2021

Contract development and manufacturing organization, Catalent, has invested in the capabilities at its clinical supply services facility in Philadelphia, in the US, to further support biotech firms developing cell and gene therapies.

Gene Therapy

Gene Therapy Clinical Supply Gene Manufacturing

Catalent Expands OneBio® Suite for Integrated Development, Manufacturing and Supply Across Biologic Modalities

The Pharma Data

JUNE 7, 2023

Originally launched in 2019 for early-phase protein therapy development, OneBio Suite offers customers an integrated service to accelerate programs from development to manufacturing, including fill/finish and packaging, and support for clinical supply and commercial launch.

Manufacturing

Manufacturing Development Protein Gene Therapy

Untangling the Complexities of Cell and Gene Therapy Clinical Trials: A Supply Chain Perspective

Pharmaceutical Technology

MAY 24, 2023

By Luisa Sterkel & Joana Loureiro , Tenthpin Consultants The promise and potential of cell and gene therapies (CGT) has emerged in the recent past and currently over 1.500 CGT are registered for clinical trials holding great hope for the treatment of challenging and uncurable diseases.

Clinical Trials

Clinical Trials Clinical Trials Gene Therapy Clinical Supply Chain

Oxford Biomedica and Beam Therapeutics sign CAR-T deal

The Pharma Data

AUGUST 4, 2020

The agreement also puts in place a three year clinical supply agreement for the two companies. Under the terms of the deal, Oxford Biomedica will receive an undisclosed upfront payment, with additional payment related to development and manufacturing of lentiviral vectors for use in clinical trials. .

Gene Editing

Gene Editing Licensing Licensing Clinical Supply

CSL makes $4bn+ move in mRNA vaccines with Arcturus deal

pharmaphorum

NOVEMBER 2, 2022

“This collaboration is an exciting opportunity to complement CSL’s own next-generation mRNA programme with a partner who developed a platform to deliver late stage clinical supplies at scale,” said CSL’s chief operating officer Paul McKenzie.

Vaccination

Vaccination Vaccine Immune Response Gene Therapy

Overcoming inefficiencies to improve access to cell and gene therapy

Drug Discovery World

MARCH 13, 2023

The cell and gene therapy (CGT) landscape has grown significantly in the past year. Between the 24 therapies already approved by the FDA 1 and a marked increase in clinical trials, widespread accessibility to precision medicine feels within reach. One example: Zynteglo, a newly approved gene therapy priced at a record-breaking $2.8M

Gene Therapy

Gene Therapy Gene Manufacturing Development

Keeping tabs on Covid-19: BioNTech buys GMP-certified facility to boost vaccine…

The Pharma Data

SEPTEMBER 18, 2020

BioNTech plans to manufacture additional therapeutic and vaccine drug candidates at the plant, such as other mRNA vaccines, antibody and cell and gene therapy candidates to support the development of its diversified cancer and infectious disease product pipeline.

Vaccination

Vaccination Vaccine Manufacturing Clinical Supply Chain

J&J’s Carvykti and BMS’ Abecma Win FDA Approvals for Earlier Use in Multiple Myeloma

XTalks

APRIL 11, 2024

The companies have also expanded a contract manufacturing agreement with Novartis that will help produce Carvykti for both commercial and clinical supply at the New Jersey plant through the end of 2029. 2seventy has been used to the struggles ever since it spun out of gene therapy biotech bluebird bio.

FDA Approval

FDA Approval Manufacturing Trials Clinical Trials

VTX-801 RECEIVES U.S. FDA FAST TRACK DESIGNATION FOR THE TREATMENT OF WILSON DISEASE

The Pharma Data

AUGUST 15, 2021

Vivet Therapeutics (“Vivet”), a clinical-stage biotechnology company, and Pfizer Inc. VTX-801 is a novel investigational gene therapy to be evaluated in a Phase 1/2 clinical trial to determine the safety, tolerability, and pharmacological activity of a single intravenous infusion in adult patients with Wilson Disease.

Gene Therapy

Gene Therapy Gene Clinical Trials Clinical Trials

A supply chain to match the changing face of science

Drug Discovery World

NOVEMBER 3, 2022

Ten years ago, cell and gene therapy (CGT) was really finding its feet as success stories such as that of Emily Whitehead began to hit the news. Paul Viggers has spent 15 years working within the Life Science Industry providing leadership in both Clinical and Commercial Business Development. The catalysts . References .

Gene Therapy

Gene Therapy Production Development Business Development

Clinical Research Informer

Catalent Adds New Cryogenic Capabilities at Shiga, Japan, Facility to Support Clinical Supply Demand for Cell and Gene Therapy Development

Rentschler Biopharma and Ikarovec partner to expedite new gene therapies

Trending Sources

Sharp completes new gene therapy packaging and distribution capacity in The Netherlands

Why demand is rising for secure and climate-controlled gene therapy services

Catalent looks to meet needs of expanding CGT market, completes expansion work at biologics drug substance facility

Catalent Expands OneBio® Suite for Integrated Development, Manufacturing and Supply Across Biologic Modalities

Untangling the Complexities of Cell and Gene Therapy Clinical Trials: A Supply Chain Perspective

Oxford Biomedica and Beam Therapeutics sign CAR-T deal

CSL makes $4bn+ move in mRNA vaccines with Arcturus deal

Overcoming inefficiencies to improve access to cell and gene therapy

Keeping tabs on Covid-19: BioNTech buys GMP-certified facility to boost vaccine…

J&J’s Carvykti and BMS’ Abecma Win FDA Approvals for Earlier Use in Multiple Myeloma

VTX-801 RECEIVES U.S. FDA FAST TRACK DESIGNATION FOR THE TREATMENT OF WILSON DISEASE

A supply chain to match the changing face of science

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