Manufacturing

Articles

This approval marks the second gene therapy to be approved by FDA and the first to be approved for certain types of non-Hodgkin lymphoma.

FDA Approves Kite’s CAR-T Drug, Second Gene-Therapy in US

The committee has voted unanimously to approve Spark Therapeutics’ gene therapy candidate, Luxturna (voretigene neparvovec), for treating a genetically inherited blindness.

FDA Committee Recommends Approval of Spark’s Eye-Disease Gene Therapy

The Cell and Gene Therapy Catapult, one of UK’s centers of excellence, has partnered with Japan’s Forum for Innovative Regenerative Medicine to boost their respective stances in the global cell and gene therapy landscape.

UK’s Cell and Gene Therapy Catapult Partners with Japan

HTG, a company that provides molecular profiling services, expects to complete submission of its premarket approval application to FDA for an in vitro gene assay by 2018.

HTG Molecular Diagnostics to Complete FDA Filing for Gene Assay

Pfizer will invest $100 million to expand its manufacturing facilities in Sanford, North Carolina.

Pfizer Plans Gene Therapy Manufacturing Investment in North Carolina

Licensing agreement will expand Oxford Genetics bio-therapeutic discovery, design, and development service business.


Oxford Genetics Licenses CRISPR Gene Editing Technology from ERS Genomics

Spark Therapeutics and Selecta entered a license agreement for Selecta’s gene-therapy co-administration technology.

Spark Licenses Selecta’s Gene-Therapy Administration Technology

Oxford Genetics has secured a GBP1 million capital from investment group Mercia Technologies to support its growth strategy in delivering new services for cancer-fighting gene-therapy technologies.

Oxford Genetics Secures GBP1 Million Investment for Gene Therapy Technologies

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

FDA’s new Office of Tissues and Advanced Therapies will oversee a growing range of cellular and genetic products.

FDA Tackles Cellular, Gene Therapies

Caroline Hroncich was associate editor for Pharmaceutical Technology, Pharmaceutical Technology Europe, and BioPharm International from 2015 to 2017.

Scientists from the Fred Hutchinson Cancer Research Center have developed a semi-automated benchtop system for the manufacture of gene therapy.

Manufacturing, Gene Therapies