Manufacturing, Cell Therapies

UK-based Orchard Therapeutics and PharmaCell ally to support clinical trials and commercialization of Orchard’s ex-vivo gene therapies.

There is much work to do to achieve efficient, cost-effective production processes.

At the American Society of Hematology Annual Meeting, Novartis and Kite Pharma both released results from early-phase clinical trials with CAR-T therapies.

In addition to having the optimal cell line and process, it is crucial to have the optimal cell culture medium and feed to maximize performance potential.

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.

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

Horizon announces new bioproduction outlicense deal with an unnamed partner for a minimum value of £500,000.

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

BioPharm International spoke with Selexis CEO and Chairman Igor Fisch, PhD about the latest cell-line development advances.

Experts discuss recent advances in cell viability testing methods in bioreactors.

WuXi AppTec’s new biomanufacturing facility is its third facility in the Philadelphia, PA Navy Yard.

A new virus-retentive membrane may be used to filter chemical-defined cell culture media for risk mitigation.

Advances in cell culture media technology have helped achieve safer biologics.

Quality, flexibility, and cost savings are driving use of perfusion technology in biosimilars manufacturing.

On July 25, 2016 Kite Pharma entered into an agreement with the University of California, Los Angeles,  (UCLA) to advance development of off-the-shelf allogenic T-cell therapies from renewable pluripotent stem cells. The company entered into an exclusive license agreement with UCLA for an artificial thymic organoid (ATO) cell culture system. The ATO replicates the human thymic environment to support efficient ex vivo differentiation of T-cells from primary and reprogrammed pluripotent stem cells.

The collaboration will focus on the investigational candidate JTX-2011 and up to four other early-stage programs in immune-oncology.

GE further ramps up its cellular and gene therapy offerings with its acquisition of Biosafe, a cell processing solutions company.

A research team associated with Dr. Carl June announces it has discovered a way to engineer a patient’s own immune cells to recognize cancer-specific glycoantigens on tumor cells.

The first-ever use of CRISPR in humans will be evaluated by the National Institutes of Health during a meeting from June 21–22, 2016.

Results of a Phase II clinical trial reveal that stem-cell transplantation treatment following complete immune system destruction increases the duration of long-term remission in patients with multiple sclerosis.

Brammer Bio establishes late-phase development and commercial manufacturing facility for advanced cell and gene therapies in Lexington, MA.

The Cell and Gene Therapy Catapult released a review of their third annual survey of GMP cell and gene therapy facilities in the United Kingdom.

Data acquired from osmolality, glucose, and folic acid tests provides useful information for the specific identification of cell-culture media.

Early successes drive the need to overcome safety issues, increase efficacy, and address manufacturing challenges.

Developers of CAR-T cell therapies with products showing successful early-stage clinical results are currently seeking manufacturing capacity that will enable the production of the larger quantities of material needed for Phase III trials and eventual commercialization.