Process validation for recombinant adeno-associated virus vectors in rare diseases: challenges for MAAs
Published: May 16, 2019
Preparing to navigate European regulatory requirements for gene therapy process validation
Published: May 16, 2019
Planning for Success: Emerging GMP-Grade Raw Materials & Technologies for Cell Therapy
Published: April 15, 2019
Cell Therapy Quality/CMC & Analytics – Full Spotlight
Published: February 21, 2019
European regulator’s perspective: best practice & future directions in cell therapy CMC
Published: February 15, 2019
Commercial Lessons for Clinical Success
Published: February 4, 2019
Management of ‘out of specification’ commercial autologous CAR-T cell products
Published: December 17, 2018
Joined-up thinking: success criteria for tomorrow’s viral vector production platforms
Published: December 3, 2018
New Gene Therapy CMC Guidance from the FDA – A Breakthrough in Regulation or Something More Generic?
Published: August 15, 2018
Accelerated Access of Advanced Regenerative Therapies: an Industry Perspective
Published: August 6, 2018
Breakthrough Therapy Designation & Regenerative Medicine Advanced Therapy Designation Programs in Cellular & Gene Therapies
Published: July 30, 2018
The Regulatory Environment for Cell Therapies in Australia – an Opportunity to Expedite Clinical Development
Published: July 30, 2018
Experiences from Japan – SAKIGAKE Designation System for Regenerative Medical Products
Published: July 17, 2018
Proposed Solutions to Further Improve the Regulatory Landscape for ATMPS in Europe
Published: July 17, 2018
Nohla Therapeutics bags $56 million in Series B financing to fund cell therapy platform
Published: July 16, 2018
Drugs targeting interleukin-1 could eradicate cytokine release syndrome seen in CAR-T therapies
Published: June 8, 2018
Introducing controllable switches could improve the safety profile of CAR-T therapy
Published: June 1, 2018
Bluebird bio’s stem cell-gene therapy receives FDA’s breakthrough therapy designation
Published: May 29, 2018
Cellectis’ off-the-shelf CAR-T therapy trial to proceed with amended protocol
Published: May 23, 2018
Harvard university licenses base editing technology to Beam Therapeutics
Published: May 14, 2018
Latest Developments in Viral and Non-Viral Vector Manufacturing – Download Spotlight
Published: March 16, 2018
Regulatory pathway on the manufacture & quality control of recombinant adeno-associated virus vectors
Published: March 15, 2018
Caladrius bags exclusive license to Shire’s cell therapy program for refractory angina
Published: March 7, 2018
FDA publishes new designation for regenerative medicines
Published: November 21, 2017
Orphan designation for Pluristem’s ARS placenta cell therapy
Published: October 23, 2017
An alternative to patents: can DNA be protected by copyright and design right law?
Published: October 19, 2017
Setting the standards for cryopreservation of stem cells for clinical applications
Published: June 13, 2017
CAR-T Manufacturing Spotlight – Download Complete Issue
Published: May 15, 2017
The regulation of CAR-T cells
Published: May 5, 2017
Impact of raw & starting materials on the manufacture and regulation of gene & cell therapies
Published: April 11, 2017
