Expert Panels 2019 Recorded Content

The second content page for this event contains with audio recording and slides for each panel. Underneath these is the program for the meeting, with excerpts from pre-recorded interviews with Experts who were unable to attend on the day.

Listen to the Expert Panels

View slides used to lead Expert Panel discussion

PSC Manufacturing Expert Panels 2019 Slides (as PDF document)Download

Organizers’ Summary Slides from Closing Panel Download

13.00-13.25 Opening Panel

Review of takeaways from last years CIRM/IABS PSC Manufacturing, Standards, & Controls meeting and objectives and context for this year’s discussion

Chair: Dr Stephen Lin (CIRM)

Download the CIRM/IABS PSC Manufacturing, Standards & Controls Meeting Report here Download

13.30-13.55 Panel 2

Pluripotent stem cells as manufacturing cell substrates – challenges encountered and forecast

Chair: Dr Wen Bo Wang (Fate Tx)

Excerpt: PSC/iPSC therapeutic manufacturers should consider the clinical usability of their product from the beginning of the translation process. Besides safety, efficacy, and cost, usability is be a key parameter determining overall clinical impact – Dr Bill Shingleton (HESI CT-TRACS, Asymptote). [Apologies for the poor visual quality of this excerpt.]

See manufacturing cell substrates panel participants (TBI)

Download the UKRMP Cell Manufacturing Workshop Report here Download

14.00-14.25 Panel 3

International standardization of human pluripotent stem cell manufacturing – rationale and review of current status

Chair: Prof Glyn Stacey (ISCBI/SSCBio Ltd./Beijing Stem Cell Bank)

Excerpt: Standardization of iPSC lines as Starting Material for Therapeutic Development – Prof Marc Turner (GAiT, SNBTS)

Efficiencies of PSC/iPSC translation effort are assisted by the different professional silos being aware of the others’ activities and challenges. The properties a PSC/iPSC cell line must have to gain regulatory approval as a starting material for manufacture, for example, may not always be discernible to academic colleagues and these are helpful for all focused on clinical translation to be aware of – Prof Marc Turner (GAiT, SNBTS)

See international standardization panel participants

Download the Scientific considerations for
the regualtory evaluation of cell therapy products paper here Download

14.30-14.55 Panel 4

Defining Quality Parameters of Human Pluripotent Stem Cells as manufacturing intermediates for therapeutic development

Co-Chair: Dr Amanda Mack (Fujifilm Cellular Dynamics International)

Co-Chair: Assoc Prof Ngaire Elwood (ISCT/Murdoch’s Children’s Research Institute/FACT/ BMDI Cord Blood Bank)

Excerpt: Opportunity in learning from MSCs: choosing appropriately stringent Critical Quality Attributes for PSCs/iPSCs will assist reproducibility and interpretation of clinical data -Prof Marc Turner (GAiT, SNBTS)

Download Quality Control Guidelines for clinical grade iPSC lines here Download

15.00-15.25 Panel 5

Outlining a road map to cell therapy comparability

Chair: Prof Jo Mountford (GAiT/SNBTS/University of Glasgow)

Excerpt: Provenance of materials used impacts the quality of PSC/iPSC lines, which then in turn, also affects the quality of therapeutic products derived therefrom. – Prof Marc Turner (GAiT, SNBTS)

Excerpt: Initial steps towards PSC/iPSC line comparability: (i) selecting and periodically revising Critical Quality Attributes as a community, (ii) selecting what quality assays and what standards to use, and (iii) ensuring quality testing, conducted by different users across the community, is consistent and indicative. – Prof Marc Turner (GAiT, SNBTS)

See comparability panel participants (TBI)

Download the strategic road map to filing a Biologics License Application for a pluripotent stem cell derived therapeutic product Download

15.25-16.00 Bathroom Break

16.00-16.25 Panel 6

Towards standardized tumorigenicity testing – challenges and the way forward

Chair: Dr Yoji Sato (NIHS)

16.30-16.55 Panel 7

Towards automated and closed human Pluripotent Stem Cell Manufacture

Co-Chair: Dr Elizabeth Schwarzbach (NYSCF)

Co-Chair: Dr Mathilde Girard (YposKesi)

Excerpt: Reliance on subjective operator-based judgements limits the progress of the PSC field -Dr Ricardo Baptista (Ex-Cell & Gene Therapy Catapult)

17.00-17.15 Panel 8

Financial and Logistical Challenges to human Pluripotent Stem Cell Manufacture

Co-Chair: Dr Rajesh Ambasudhan (Allele Biotech)

Co-Chair: Dr Bill Shingleton (HESI CT-TRACS, Asymptote)

Excerpt: Analytics development in the PSC/iPSC sector requires careful communication between therapeutic developers and tool makers. Disclosing what is required, and at what specification, without comprimising intellectual property is a sensitive balancing act. – Dr Bill Singleton (HESI CT-TRACS, Asymptote)