Article Provided by Miltenyi Biotec Despite a turbulent market environment, the cell and gene therapy (CGT) field continues to advance, with several groundbreaking therapies slated to receive FDA approval this year alone. The momentum is undeniable. However, the path from clinical development...
Erica Waller Senior Product Manager Cryo Automation and Stores Azenta Life Sciences Burlington, MA, USA Cryopreservation, the process of preserving cells, tissues, and organs at extremely low temperatures, stands out as a pivotal technique in modern medicine. As we push the boundaries of...
Sponsored Article provided by Akron Biotech Robert Margolin Vice President, Commercial Akron BioProducts Ezequiel Zylberberg Vice President, Corporate Development Akron BioProducts Allen Parsons Associate, Regulatory Affairs Akron Bio Mahajoub Bello...
Pittsburgh, Pa., August 23, 2024 — Cook MyoSite announced that the first participant was treated in the DigniFI Study, a two-stage, randomized, controlled Phase III trial comparing the safety and efficacy of iltamiocel with placebo in the treatment of female participants with chronic fecal...
by Fajar Dumadi, BSc Regulatory Program Specialist ISCT Head Office This draft guidance provides recommendations for developing a science- and risk-based strategy to help assure the potency of a human cellular therapy or gene therapy (CGT) product. This draft guidance document, when finalized...
Sponsored Content from Stemcell Technologies The cell and gene therapy field is rapidly advancing as shown by the growing number of clinical trials and regulatory-approved therapies.¹ As the breadth of cell types, technology platforms, and target diseases continues to evolve, so too...
by Laine Bodnar Senior Manager Communications CCRM Whether you’ve visited Canada or not, you probably know that it’s famous for beautiful scenery, maple syrup and ice hockey. Canada is also where Drs. James Till and Ernest McCulloch defined the hallmark properties of stem cells in the...
by Katy Spink, Ph.D., Dark Horse Consulting Group’s COO & MP Katy Spink Presents at an Internal DHC Retreat in 2018 Full disclosure: my CGT career began just over 20 years ago when I worked with pluripotent stem cells at Geron . I’ve always been a believer in the...
by Dr. Steve Oh, PhD Independent Cell Therapy Leader Singapore A webinar presented by the ISCT Process Development and Manufacturing (PDM) Committee Particulates are everywhere but do they pose a problem in cell and gene therapy products? On the 16 Oct. the...
ISCT’s Process Development & Manufacturing Committee invites you to take part in a survey to determine the current state of Process Analytical Technologies (PAT) in Cell & Gene Therapy (C>) Manufacturing. Fundamental analytical challenges exist when manipulating and expanding...