Xenotransplantation
Xenotransplantation is any procedure that involves the transplantation, implantation or infusion into a human recipient of either
- live cells, tissues, or organs from a nonhuman animal source, or
- human body fluids, cells, tissues or organs that have had ex vivo contact with live nonhuman animal cells, tissues or organs.
The development of xenotransplantation is, in part, driven by the fact that the demand for human organs for clinical transplantation far exceeds the supply.
Featured Products
Best Practices in Quality and Compliance Management
Price: $70.00
Price: $70.00
Immunogenicity To Biologics: Processes, Impact On Efficacy And Safety, and Management Strategy
Processes and effects of immunogenicity to biologics - screening methodologies - regulatory mandates - commercial repercussions of unwanted immune responses
Processes and effects of immunogenicity to biologics - screening methodologies - regulatory mandates - commercial repercussions of unwanted immune responses
Differences in GMP Requirements between Drugs and Biologics
Biologics regulations - drug regulations - differences in GMP requirements
Biologics regulations - drug regulations - differences in GMP requirements
Quality Expectations for Drugs and Biologics during Early Development: Phase 2
Phase 2 FDA Guidance Documents - QC studies - CMC quality elements - Common Technical Document CTD - Biologics License Application BLA - New Drug Application NDA
Phase 2 FDA Guidance Documents - QC studies - CMC quality elements - Common Technical Document CTD - Biologics License Application BLA - New Drug Application NDA