Manufacturing, Gene Therapies

The company is investing $130 million to add Phase III through commercial-scale manufacturing suites to its gene therapy campus in Harmans, MD.

This article will explore the traditional path from the laboratory to the clinic and how the fixed-bed technology provides an alternative solution to meet commercial demands.

The cell banks were created using current good manufacturing practices and can be used each time CombiGene produces new plasmids for the production of its gene therapy, CG01.

The therapy, indicated for a rare form of B-cell non-Hodgkin’s lymphoma, was developed by Kite, a Gilead company, which will manufacture the therapy at its facility in El Segundo, CA.

Sangamo will receive a $75 million upfront license fee payment and will be eligible to earn up to $720 million in other development and commercial milestone payments, including up to $420 million in development milestones and up to $300 million in commercial milestones.

This method is expected to help bring gene therapies to market faster, safer, and cheaper.

RNA is easier to manipulate than DNA but challenging to deliver to the right cells.

The site can now support customized product and bioprocess development and custom cell and gene therapy reagent manufacturing.

The companies are entering into a license agreement to provide CSL Behring with exclusive global rights to etranacogene dezaparvovec, uniQure’s investigational gene therapy for patients with hemophilia B.

The company will invest $75 million into its Canton, MA, facility to expand its viral vector, gene therapy, and contract development and manufacturing capabilities.

Previous investments set a foundation for later efficiency improvements.

Working with incubators can provide cell and gene therapy developers with more opportunities.

Ori Biotech is partnering with manufacturers and materials suppliers to develop an automated system for cell and gene therapy manufacturing.

The company will invest $180 million to construct a new 290,000-ft2 facility in Plainville, MA.

Hitachi Chemical Advanced Therapeutics Solutions and apceth Biopharma entered into long-term development and manufacturing services agreements for the clinical and commercial supply of multiple bluebird bio therapies.

The center will be located at NJIT’s Life Sciences and Engineering center and will feature two good manufacturing practices suites that are expected to be completed and operational during the summer of 2020.

The new cell-line producing platform enables fully scalable production of high-performance adeno-associated virus vectors.

Viral vectors show promise as a delivery mechanism for gene therapy, but which virus types are commercially viable?

The company will build an additional commercial-scale, contract manufacturing facility for viral vectors and gene therapies near its existing site in Carlsbad, CA.

The new patented process results in uniform, scalable production and the ability to deliver cell cargo similar to natural exosomes/extracellular vesicles.

Daiichi Sankyo has entered into a partnership with Ultragenyx Pharmaceutical for the use of Ultragenyx’s proprietary AAV-based gene-therapy manufacturing technology.

Thermo Fisher is focused on investing to expand three specific areas of demand: biologics, cell and gene therapy, and drug product development and commercial capabilities.

In January 2020, the agency finalized six clinical development and manufacturing guidance documents and drafted new guidance on what would qualify new gene therapies as orphan drugs.

The 135,000 square foot facility will be constructed over 18 months and is expected to be operational in 2021.

Technology and capacity investments create opportunities in the cell and gene therapy arena for CDMOs and biopharma alike.