Manufacturing

Articles

The final guidance provides recommendations for developing gene therapy products incorporating genome editing of human somatic cells.

FDA Give Guidance on Human Genome Editing in Gene Therapies

Feliza Mirasol is the science editor for 

Charles River’s off-the-shelf rep/cap plasmids are intended to simplify gene therapy supply chains.

Charles River Launches Off-the-Shelf Rep/Cap Plasmids for AAV Vector Manufacturing

Chris Spivey is director of Industry Relations and Strategic Partnership, MJH Life Sciences.

Revolutionary therapies restructure pharmaceutical manufacturing.

Leap Year

There are positive indications for future growth.

New Therapies Cry Out for New Skills

Tome Bioscience is facilitating the transition in biology from the editing phase to the cut-and-paste phase.

Tome brings $213 Million to the Programmable Genome Editing Party

Andelyn Biosciences has been selected by Ultragenyx to manufacture UX111, that company’s gene therapy for treating Sanfilippo Syndrome.

Ultragenyx Picks Andelyn Biosciences to Manufacture Novel Gene Therapy for Sanfilippo Syndrome

RoslinCT will manufacture Vertex Pharmaceuticals’ CRISPR-based gene therapy, Casgevy, recently approved for treating sickle cell disease and β thalassemia.

RoslinCT to Manufacture CRISPR-Based Gene Therapy Casgevy

John Lewis, PhD, is CEO of Entos Pharmaceuticals.

Collaboration is a key component to achieving long-term success with genetic medicines.

Risks and Rewards of Investing in RNA-based Genetic Medicine Manufacturing

Exagamglogene autotemcel seen as synechdoche.

New Medicines, Markets, and Manufacture: CRISPR for Sickle Cell Disease and β-thalassemia

Jennifer Markarian is a contributing editor for 

Emergence of advanced manufacturing technology to ensure quality of biopharmaceutical drugs combined with efforts to identify a regulatory pathway indicate that a distributed manufacturing model is within reach. 

Manufacturing, Gene Therapies