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제목 [GAiT post] 2017/10/11 (Quality Standards Workshop - key decisions made) 등록일 2017.11.12 16:23
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Quality Consensus - Summary of decisions made at GAiT Quality Standards workshop
Dear all,
  • Thanks to all who attended the GAiT Quality Standards Workshop last week.
  • Please find below a summary of the key decisions made concerning critical quality attributes for iPSC lines to be considered for the GAiT haplobank network. We circulate this to all GAiT associates to make sure that our understanding of the decisions made has been faithfully captured and to allow thought and additional discussion.
    • Please note there is now a LinkedIn group for GAiT (here) in addition to the Twitter account  (@iPSCtherapies). Conversation concerning the workshop should have the hashtag #gait2017.
    • When the new GAiT website & database is up and running in the coming months, discussion boards will be included to facilitate discussion and mutual understanding.
  • We are now preparing a manuscript around the agreed consensus which will give further detail. A draft will be circulated to attendees after Board approval shortly.
  • Again, we are very grateful to Glyn Stacey, our visiting Quality Standards chair, who did an excellent job chairing.
Kind regards,
Stephen Sullivan
GAiT - the Global Alliance for iPSC Therapies
Resolution of decisions made at the GAiT iPSC Quality Standards workshop (5th October 2017 / Sheffield, UK.)
 
Critical Quality AttributeRecommended test methodComments
STRSTR profiles
 
Mandatory
Use a commercially available kit performed by accredited personnel

Check allele coverage with GAiT

SNP or other test may be used in-house and contributed as data for information but difficulties with different algorithms mean GAiT needs data that can be compared easily across centres
MycoplasmaQualified qPCR or culture (broth/agar or Vero inoculation/DNA stain) methodMandatory
Use of Pharmacopoeia methods
KaryotypeG BandingMandatory
SNP valuable for information and keep watching brief
ViabilityDye exclusion test on thawing
Recovery of a typical iPSC culture (action NIBSC)
Mandatory
More than or equal to 50% viable cells
Doubling timeNot requiredData may be added for information
ImmunophenotypeFlow cytometry or immunocytochemistry of two markers which should include a self-renewal marker (Oct4) and a stem cell surface marker (e.g. TRA-1-60, SSEA4)Required but for information to show a stem cell phenotype and not a release criterion

Additional data recommended

No tolerance on levels of expression but markers positive should typically be on >70% of cells
 
Pluripotency assaysAt least one method usedRequired but only for information to show potential to produce each germ layer
Viral testingBased on risk assessment of cells and reagents and residual risk.Mandatory as required by risk assessment of donor and process.

Donor testing for pathogens considered relevant to cell line.
Residual vector testingAppropriate sensitive assay to be usedMandatory

Action: Stephen Sullivan to contact NIBSC regarding reference materials (also consider CIRM limit of <1 copy per 100 cells)
Differentiated cellsNot requiredCovered by immunophenotyping
Cell debrisNot requiredHighly unlikely impact on product
EndotoxinRequiredMandatory
Use Pharmacopeia method
LabellingNot required as relevant not current discussion-
WGA and other genetic/epigenetic analysis/disease markersNot requiredStrongly encouraged for future reference


 
Thanks also to those how remained for the post-meeting dinner.

Our next meeting will be in Berlin on the 1st November 2017 and will be chaired by Andreas Kurtz. We shall
agree HLA- and clinical grade iPSC- data fields for the GAiT database.More details to follow.