- Quality and Regulatory Challenges Surrounding New Cell and Gene Therapy . . .
Jennifer Cheung of WuXi Advanced Therapies explores the evolving quality and regulatory challenges facing cell and gene therapy developers and the progress toward widely applicable solutions
- Redefining quality in cell and gene therapies: Lessons from . . .
Quality assurance (QA) and quality control (QC) roles are typically understaffed, forcing personnel to juggle a wide range of responsibil-ities such as deviations, SOP revisions, and project-specific assay development and qualification
- Careers at CTMC | Join Us in Advancing Cell Therapy
Explore career opportunities at CTMC and be part of a purpose-driven team accelerating cell therapy development Join us in uniting science, clinical expertise, and manufacturing to impact patient lives
- Understanding Critical Quality Attributes (CQAs) in T-Cell and MSC Therapy
Sterility testing is a universal quality requirement across all cell therapy categories For allogeneic cells and tissues, the FDA mandates donor screening for transmissible infections, including HIV-1 2, hepatitis B, hepatitis C, transmissible spongiform encephalopathy, and syphilis
- For cell therapies, raw material quality hinges on the human touch
When it comes to cell-based therapy manufacturing, the concept of quality management carries important distinctions from more traditional therapeutics production Of course, the same rigour is
- Achieving Efficient Manufacturing and Quality Assurance through . . .
These strategies could help overcome unresolved cell therapy manufacturing challenges and complement frameworks to design quality into these complex cellular systems, ultimately increasing patient access to living therapeutics
- Quality Assurance and Control for Safe and Effective Therapy
Ensure cell and gene therapy safety and efficacy with Revvity’s quality control and assurance solutions Discover LabChip, AlphaLISA, and nucleic acid tools
- Quality Control and Assurance in Cell Therapy: Building Robust Systems . . .
By Dr Hemant Gupta, Principal Scientist In the manufacture of cell and gene therapies, where the product is a living, complex biological entity administered directly to patients, Quality Control
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