Exclusion
LQT08-hiPSC
Exclude from clean allogeneic source-line shortlist.
Disease-model or disease-related mutation evidence is present.
StatusExclusion
Prioritized evidence work across HLA typing, commercial rights, CoA/GMP documentation, and genomics/omics gaps.
Exclusion
Exclude from clean allogeneic source-line shortlist.
Disease-model or disease-related mutation evidence is present.
Exclusion
Exclude from clean allogeneic source-line shortlist.
Genetic modification is present or reported for this line.
Next evidence
Obtain high-resolution HLA-A/B/C/DRB1/DQB1/DPB1 typing before population-fit claim.
Population-fit readiness cannot be computed without allele-level HLA typing.
Rights review
Verify donor consent and commercial-use rights.
Commercial-use rights are a blocker for source-line selection.
Next evidence
Obtain high-resolution HLA-A/B/C/DRB1/DQB1/DPB1 typing before population-fit claim.
Population-fit readiness cannot be computed without allele-level HLA typing.
Rights review
Verify donor consent and commercial-use rights.
Commercial-use rights are a blocker for source-line selection.
Next evidence
Obtain high-resolution HLA-A/B/C/DRB1/DQB1/DPB1 typing before population-fit claim.
Population-fit readiness cannot be computed without allele-level HLA typing.
Rights review
Verify donor consent and commercial-use rights.
Commercial-use rights are a blocker for source-line selection.
Next evidence
Obtain high-resolution HLA-A/B/C/DRB1/DQB1/DPB1 typing before population-fit claim.
Population-fit readiness cannot be computed without allele-level HLA typing.
Rights review
Verify donor consent and commercial-use rights.
Commercial-use rights are a blocker for source-line selection.
Next evidence
Obtain high-resolution HLA-A/B/C/DRB1/DQB1/DPB1 typing before population-fit claim.
Population-fit readiness cannot be computed without allele-level HLA typing.
Rights review
Verify donor consent and commercial-use rights.
Commercial-use rights are a blocker for source-line selection.
Next evidence
Obtain high-resolution HLA-A/B/C/DRB1/DQB1/DPB1 typing before population-fit claim.
Population-fit readiness cannot be computed without allele-level HLA typing.
Rights review
Verify donor consent and commercial-use rights.
Commercial-use rights are a blocker for source-line selection.
Next evidence
Obtain high-resolution HLA-A/B/C/DRB1/DQB1/DPB1 typing before population-fit claim.
Population-fit readiness cannot be computed without allele-level HLA typing.
Rights review
Verify donor consent and commercial-use rights.
Commercial-use rights are a blocker for source-line selection.
Next evidence
Obtain high-resolution HLA-A/B/C/DRB1/DQB1/DPB1 typing before population-fit claim.
Population-fit readiness cannot be computed without allele-level HLA typing.
Rights review
Verify donor consent and commercial-use rights.
Commercial-use rights are a blocker for source-line selection.
Next evidence
Obtain high-resolution HLA-A/B/C/DRB1/DQB1/DPB1 typing before population-fit claim.
Population-fit readiness cannot be computed without allele-level HLA typing.
Rights review
Verify donor consent and commercial-use rights.
Commercial-use rights are a blocker for source-line selection.
Quality documentation
Obtain or review a formal CoA package.
Basic catalogue evidence is not a substitute for formal release documentation.
Quality documentation
Review GMP documentation and chain-of-custody package.
CMC planning needs GMP provenance before clinical development assumptions.
Quality documentation
Obtain or review a formal CoA package.
Basic catalogue evidence is not a substitute for formal release documentation.
Quality documentation
Review GMP documentation and chain-of-custody package.
CMC planning needs GMP provenance before clinical development assumptions.
Quality documentation
Obtain or review a formal CoA package.
Basic catalogue evidence is not a substitute for formal release documentation.
Quality documentation
Review GMP documentation and chain-of-custody package.
CMC planning needs GMP provenance before clinical development assumptions.
Quality documentation
Obtain or review a formal CoA package.
Basic catalogue evidence is not a substitute for formal release documentation.
Quality documentation
Review GMP documentation and chain-of-custody package.
CMC planning needs GMP provenance before clinical development assumptions.
Quality documentation
Obtain or review a formal CoA package.
Basic catalogue evidence is not a substitute for formal release documentation.
Quality documentation
Review GMP documentation and chain-of-custody package.
CMC planning needs GMP provenance before clinical development assumptions.
Quality documentation
Obtain or review a formal CoA package.
Basic catalogue evidence is not a substitute for formal release documentation.
Quality documentation
Review GMP documentation and chain-of-custody package.
CMC planning needs GMP provenance before clinical development assumptions.
Quality documentation
Obtain or review a formal CoA package.
Basic catalogue evidence is not a substitute for formal release documentation.
Quality documentation
Review GMP documentation and chain-of-custody package.
CMC planning needs GMP provenance before clinical development assumptions.
Quality documentation
Obtain or review a formal CoA package.
Basic catalogue evidence is not a substitute for formal release documentation.
Quality documentation
Review GMP documentation and chain-of-custody package.
CMC planning needs GMP provenance before clinical development assumptions.
Quality documentation
Obtain or review a formal CoA package.
Basic catalogue evidence is not a substitute for formal release documentation.
Quality documentation
Review GMP documentation and chain-of-custody package.
CMC planning needs GMP provenance before clinical development assumptions.
Genomic qc
Run or review SNP/CNV evidence.
Genome-wide copy-number evidence is missing or not reviewed.
Genomic qc
Review WES or indel evidence for candidate line risk.
Small variant evidence is needed before a stronger readiness claim.
| Priority | Line | Type | Recommendation | Rationale | Status |
|---|---|---|---|---|---|
| P0 | LQT08-hiPSC | Exclusion | Exclude from clean allogeneic source-line shortlist. | Disease-model or disease-related mutation evidence is present. | Exclusion |
| P0 | PB01-EiPS21-EGFP04 | Exclusion | Exclude from clean allogeneic source-line shortlist. | Genetic modification is present or reported for this line. | Exclusion |
| P1 | KSCBi005-A | Next evidence | Obtain high-resolution HLA-A/B/C/DRB1/DQB1/DPB1 typing before population-fit claim. | Population-fit readiness cannot be computed without allele-level HLA typing. | Open |
| P1 | KSCBi005-A | Rights review | Verify donor consent and commercial-use rights. | Commercial-use rights are a blocker for source-line selection. | Open |
| P1 | KSCBi018-A | Next evidence | Obtain high-resolution HLA-A/B/C/DRB1/DQB1/DPB1 typing before population-fit claim. | Population-fit readiness cannot be computed without allele-level HLA typing. | Open |
| P1 | KSCBi018-A | Rights review | Verify donor consent and commercial-use rights. | Commercial-use rights are a blocker for source-line selection. | Open |
| P1 | KSCBi019-A | Next evidence | Obtain high-resolution HLA-A/B/C/DRB1/DQB1/DPB1 typing before population-fit claim. | Population-fit readiness cannot be computed without allele-level HLA typing. | Open |
| P1 | KSCBi019-A | Rights review | Verify donor consent and commercial-use rights. | Commercial-use rights are a blocker for source-line selection. | Open |
| P1 | KSCBi020-A | Next evidence | Obtain high-resolution HLA-A/B/C/DRB1/DQB1/DPB1 typing before population-fit claim. | Population-fit readiness cannot be computed without allele-level HLA typing. | Open |
| P1 | KSCBi020-A | Rights review | Verify donor consent and commercial-use rights. | Commercial-use rights are a blocker for source-line selection. | Open |
| P1 | KSCBi021-A | Next evidence | Obtain high-resolution HLA-A/B/C/DRB1/DQB1/DPB1 typing before population-fit claim. | Population-fit readiness cannot be computed without allele-level HLA typing. | Open |
| P1 | KSCBi021-A | Rights review | Verify donor consent and commercial-use rights. | Commercial-use rights are a blocker for source-line selection. | Open |
| P1 | KSCBi027-A | Next evidence | Obtain high-resolution HLA-A/B/C/DRB1/DQB1/DPB1 typing before population-fit claim. | Population-fit readiness cannot be computed without allele-level HLA typing. | Open |
| P1 | KSCBi027-A | Rights review | Verify donor consent and commercial-use rights. | Commercial-use rights are a blocker for source-line selection. | Open |
| P1 | KSCBi028-A | Next evidence | Obtain high-resolution HLA-A/B/C/DRB1/DQB1/DPB1 typing before population-fit claim. | Population-fit readiness cannot be computed without allele-level HLA typing. | Open |
| P1 | KSCBi028-A | Rights review | Verify donor consent and commercial-use rights. | Commercial-use rights are a blocker for source-line selection. | Open |
| P1 | LQT08-hiPSC | Next evidence | Obtain high-resolution HLA-A/B/C/DRB1/DQB1/DPB1 typing before population-fit claim. | Population-fit readiness cannot be computed without allele-level HLA typing. | Open |
| P1 | LQT08-hiPSC | Rights review | Verify donor consent and commercial-use rights. | Commercial-use rights are a blocker for source-line selection. | Open |
| P1 | PB01-EiPS21-EGFP04 | Next evidence | Obtain high-resolution HLA-A/B/C/DRB1/DQB1/DPB1 typing before population-fit claim. | Population-fit readiness cannot be computed without allele-level HLA typing. | Open |
| P1 | PB01-EiPS21-EGFP04 | Rights review | Verify donor consent and commercial-use rights. | Commercial-use rights are a blocker for source-line selection. | Open |
| P2 | KSCBi005-A | Quality documentation | Obtain or review a formal CoA package. | Basic catalogue evidence is not a substitute for formal release documentation. | Open |
| P2 | KSCBi005-A | Quality documentation | Review GMP documentation and chain-of-custody package. | CMC planning needs GMP provenance before clinical development assumptions. | Open |
| P2 | KSCBi018-A | Quality documentation | Obtain or review a formal CoA package. | Basic catalogue evidence is not a substitute for formal release documentation. | Open |
| P2 | KSCBi018-A | Quality documentation | Review GMP documentation and chain-of-custody package. | CMC planning needs GMP provenance before clinical development assumptions. | Open |
| P2 | KSCBi019-A | Quality documentation | Obtain or review a formal CoA package. | Basic catalogue evidence is not a substitute for formal release documentation. | Open |
| P2 | KSCBi019-A | Quality documentation | Review GMP documentation and chain-of-custody package. | CMC planning needs GMP provenance before clinical development assumptions. | Open |
| P2 | KSCBi020-A | Quality documentation | Obtain or review a formal CoA package. | Basic catalogue evidence is not a substitute for formal release documentation. | Open |
| P2 | KSCBi020-A | Quality documentation | Review GMP documentation and chain-of-custody package. | CMC planning needs GMP provenance before clinical development assumptions. | Open |
| P2 | KSCBi021-A | Quality documentation | Obtain or review a formal CoA package. | Basic catalogue evidence is not a substitute for formal release documentation. | Open |
| P2 | KSCBi021-A | Quality documentation | Review GMP documentation and chain-of-custody package. | CMC planning needs GMP provenance before clinical development assumptions. | Open |
| P2 | KSCBi027-A | Quality documentation | Obtain or review a formal CoA package. | Basic catalogue evidence is not a substitute for formal release documentation. | Open |
| P2 | KSCBi027-A | Quality documentation | Review GMP documentation and chain-of-custody package. | CMC planning needs GMP provenance before clinical development assumptions. | Open |
| P2 | KSCBi028-A | Quality documentation | Obtain or review a formal CoA package. | Basic catalogue evidence is not a substitute for formal release documentation. | Open |
| P2 | KSCBi028-A | Quality documentation | Review GMP documentation and chain-of-custody package. | CMC planning needs GMP provenance before clinical development assumptions. | Open |
| P2 | LQT08-hiPSC | Quality documentation | Obtain or review a formal CoA package. | Basic catalogue evidence is not a substitute for formal release documentation. | Open |
| P2 | LQT08-hiPSC | Quality documentation | Review GMP documentation and chain-of-custody package. | CMC planning needs GMP provenance before clinical development assumptions. | Open |
| P2 | PB01-EiPS21-EGFP04 | Quality documentation | Obtain or review a formal CoA package. | Basic catalogue evidence is not a substitute for formal release documentation. | Open |
| P2 | PB01-EiPS21-EGFP04 | Quality documentation | Review GMP documentation and chain-of-custody package. | CMC planning needs GMP provenance before clinical development assumptions. | Open |
| P3 | KSCBi005-A | Genomic qc | Run or review SNP/CNV evidence. | Genome-wide copy-number evidence is missing or not reviewed. | Open |
| P3 | KSCBi005-A | Genomic qc | Review WES or indel evidence for candidate line risk. | Small variant evidence is needed before a stronger readiness claim. | Open |