Welcome to the RegMedNet spotlight on cell therapy commercialization and translation!
Quick access to all the content in the latest RegMedNet spotlight, including expert editorials, peer-reviewing journal content and more.
The cell therapy industry is rapidly evolving, with new techniques, technology and applications being developed all the time. After some high-profile failures, all eyes are on regulating existing therapies to ensure patient safety is paramount. Legislators, regulators and other stakeholders around world are navigating a difficult line between hope, hype and the scientific evidence.
However, even with supportive regulation, approved cell therapies will need to be truly commercially viable to meet the expectations of patients and clinicians and convince researchers and manufactures to invest in their future. With increased availability of cell therapy on the horizon, and in some cases here, it is crucial that consideration is given to adequate management of manufacture to ensure treatment reimbursement is profitable for both patients and manufacturers.
This spotlight will provide an insight into the challenges, trends, developments and debates surrounding the many factors that influence the commercial viability of a cell therapy. We will explore translation of therapies, good manufacturing practice and methods of scale-up with the help of experts from industry and academia.
- Panel discussion on commercialization and translation
- Why are we still using FBS in our processes?
- Panel discussion on cell therapy regulation
- Reprogramming and iPSC culture considerations for translational research
- Challenges of scale in cell therapy manufacturing
- Panel discussion on iPSC production and application
- A case study review on large-scale manufacturing of stem cell therapies
- Cost-benefit analysis of expanding bone-marrow-derived mesenchymal stem cells (MSCs) using automated cell expansion methods versus manual methods
- Optimizing cell therapy manufacturing through custom, single-use solutions
- Case Studies: Scaling Cell Therapy Manufacturing
- Cell therapy commercialization: GMP and Scalability
- Logical process designs for stem cell manufacturing: computational support tools for improved cost-effectiveness
- Media Matters: Serum-Free Hematopoietic Cell Culture for Gene Editing and Gene Therapy
- Brave new world: Automation, thawing, and connectivity will drive the success of cellular therapy
- Training competencies - the transition from research to a GMP environment
- Q&A transcription: Why are we still using FBS in our processes?
- Regenerative medicine research around the world
- The commercialization of cell and gene therapies: regulatory challenges
- Speaking with Masayo Takahashi: Targeting age-related macular degeneration in the first iPSC clinical trial
- Regulating advanced therapies in the UK: an interview with Michael Rawlins
- Why the FDA’s CAR-T approval sends strong signal to cell therapy industry: an interview with Martin Lamb
- Preserving biomechanics during decellularization: an interview with Antony Odell
- Commercializing regenerative medicine in the early days of a revolution: an interview with Mahendra Rao
- Choosing the right stem cell media: an interview with Biological Industries USA’s Dan Haus
- Counting on counting: a new vision for accelerating progress in regenerative medicine and drug development
- Overcoming the obstacles to a commercially successful cell or gene therapy: an interview with Dr Nafees Malik
- Commercialization of cell therapies – biopreservation’s make or break impact: an interview with Mike Rice
- Discover how MaSTherCell is enabling cell therapy development: an interview with Denis Bedoret
- Considering logistics and tracking to ensure patient safety: an interview with Martin Lamb
- Supporting innovation at Cell and Gene Therapy Catapult: an interview with Keith Thompson
- RegMedNet at Translational Opportunities in Stem Cell Research (ISSCR)
- Process modeling and optimization of a cell therapy manufacturing operation
- Scaling human pluripotent stem cell expansion and differentiation: are cell factories becoming a reality?
- Qualification of academic facilities for small-scale automated manufacture of autologous cell-based products
- Allogeneic cell therapy bioprocess economics and optimization: downstream processing decisions
- The translation of cell-based therapies: clinical landscape and manufacturing challenges
- Developing an automated robotic factory for novel stem cell therapy production
- Regulatory requirements in the good manufacturing practice production of an epithelial cell graft for ocular surface reconstruction
- Manufacturing, characterization and control of cell-based medicinal products: challenging paradigms toward commercial use
- Thermo Fisher Scientific and the Cell and Gene Therapy Catapult collaborate to optimize advanced therapy supply chain
- Teamwork makes dream work – cardiac stem cell therapy moves closer to the clinic
- Unlocking the key to scale-up of mesenchymal stem cell culture
- Large-scale iPSC production system aimed at clinical therapy funded by NIH
- Cell and Gene Therapy Catapult manufacturing center receives new investment
- ISCT revises cell and gene therapy forecast following FDA approval of Novartis CAR-T therapy
- UK Council grants Cell Therapy Catapult planning permission for large-scale GMP manufacturing centre
- Industry & research collaboration announced: Will teamwork make dream work?