• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to secondary sidebar

GAiT.Global

The Global Alliance for iPSC Therapies

  • About GAiT
    • About GAiT
    • Sponsors
      • NYSCF
      • KHiB
      • CCRM
      • INSERM / Cithera /INGESTEM
      • HKU
      • CGT
    • Support Us
  • News & Events
  • Publications
  • Workshops
  • iPSC Quality Assessment Rounds
    • iPSC Quality Assessment Round 2022
      • iPSC Quality Assessment Round 2022 – Document Page
  • Directories
  • Clinical Database
  • Portal Login
You are here: Home / Replies /

Reply To: Establishing iPSCs under GMP conditions

· ·

Home › Forums › General Discussion › General Discussion › Establishing iPSCs under GMP conditions › Reply To: Establishing iPSCs under GMP conditions

4th October 2018 at 9:36 am #1164
Stephen SullivanStephen Sullivan
Keymaster

Relevant notes from the GAiT QC Workshop:

Prospective cell line development versus “rederivation” for GMP products

Rederivation of an iPSC line involves taking a research-grade iPSC line and, after processing it properly, placing in a clinical-grade bank. This process requires gathering information retrospectively and has the advantage of not requiring a large outlay at the beginning of the derivation process. While this approach is possible, it is not recommended as retrospective collection of information is difficult. The original hESC lines, for example, were never derived with the intention of being used in clinical trials but primarily due to the limited access to IVF embryos, and the wide use of the lines to develop manufacturing processes, the H1 hESC line was subsequently rederived and used in part of Phase II Astellas Pharma’s RPE trial, similarly the rederived H9 hESC line was used to generate dopamine neurons for BlueRock Therapeutics’ Parkinson’s trial for Parkinson’s disease. However, acquiring FDA approval, developing time frames, and generating a VOM (validation of manufacturing) are all more difficult in retrospect. It is preferable to collect information prospectively as the line is generated.

It is also imperative to know and capture all the data regulators require to use the lines for cell therapeutics development. Validating the starting material is difficult, after which it is imported and processed into GMP facility. Prospective gathering of relevant information is recommended.

Additionally, reconsenting of the donor material may be required. While ISSCR have a program for assisting in the universal consent, in practice having a common consent form is very difficult as specific uses of the lines must be detailed in advance. Early development of ECTD, showing traceability and completing the donation process are all best done prospectively.

A major source of waste would be to initiate ‘GMP’ production of iPSCs from donor cells that will ultimately fail to meet all the regulatory compliance demands for a potential cell-therapeutic. Mandatory information for donation, procurement, and testing data of donor cells is required. Where parties considering the development of clinical-grade iPSC for the GAiT haplobank system, two areas are in need of particular attention: donor consent for the cells and tissues donated and the sharing of a patient’s genetic data.

Consenting to give cells or tissue for research purposes differs from consent to cells or tissue for the development of cell therapeutics or transplantation however, and this difference should not be overlooked (Lo and Parham 2009). Generic donor consent forms for tissue deposition in clinical registries do not consider reprogramming such cells into iPSCs, and their subsequent expansion, differentiation, and use in developing a therapeutic product. Data yielded from testing donor material can have medical consequences for the patient, and there is an ethical requirement to share such information once it has been identified. This can lead to a delay to further progress the cells in the iPSC derivation process.

  • This reply was modified 4 years, 4 months ago by Stephen SullivanStephen Sullivan.
  • This reply was modified 4 years, 4 months ago by Stephen SullivanStephen Sullivan.

Primary Sidebar

Search Users

Forum Search

More results...

Search Forums
Sample Label 1
Sample Label 2
Sample Label 3
Filter by Topic Tags
banking requirements
cell culture automation iPSC manufacturing scale up
comparability iPSC therapeutic CQA critical quality attribute
critical quality attributes
critical quality attributes potency iPSC testing
Database design
database front end design
donor consent
efficacy
establishment gmp
GAiTpost newsletter
iPSC IP license
manufacturing cell substrates
manufacturing comparability
manufacturing scale up therapeutic development
Melboune
Melbourne
Personal data GDPR
QC manuscript
Quality Survey
regulation
standard value use cell therapy development
standardisation control cell therapy
test
Content from
Content to
Advanced Search

Secondary Sidebar

Recent Topics

  • Regulatory Considerations for clinical-grade iPSC
  • iPSC Quality Round 2019 – Amalgamated Primary Data Set
  • Donor Consent
  • Establishing iPSCs under GMP conditions
  • Testing for efficacy

Discussion Tags

banking requirements cell culture automation iPSC manufacturing scale up comparability iPSC therapeutic CQA critical quality attribute critical quality attributes critical quality attributes potency iPSC testing Database design database front end design donor consent efficacy establishment gmp GAiTpost newsletter iPSC IP license manufacturing cell substrates manufacturing comparability manufacturing scale up therapeutic development Personal data GDPR QC manuscript Quality Survey regulation standardisation control cell therapy standard value use cell therapy development

Invite Users to Site

Invite another user onto the GAiT Website
Invite Users

Social media

Follow us on social media

GAiT LinkedIn GAit Sound Cloud GAiT Twitter

 

 

Newsletter





© 2023 GAiT. All Rights reserved. Web Design by Conceptstore
  • Home
  • Portal Login