Process and Product Development Technology
Charter
To help establish and communicate best practices in Process and Product Development as it relates to therapeutic cell-based products, and to assess emerging cell processing technologies and forecast their impact on the commercialization process
Objectives & Target Areas
- Establishing Process & Product Development as cross-functional disciplines that greatly impact cell therapy commercialization
- Therapeutic cell bioprocessing technologies and tools for upstream and downstream processing of
- patient-specific and autologous cell therapy products utilized in institutional cell processing laboratories or centralized manufacturing plants
- Allogeneic or “Universal” cell therapy products that require commercial scalability
- Serum free media, single-use bags and tubing sets, biopreservation and formulation technologies, and advances in patient delivery strategy
- In process, lot release, and cell characterization assays for monitoring the critical quality parameters of the therapeutic cell based product
Priorities
- Defining the relationships with ISCT Committees in terms of processing, assays, and standardization, with recommendations for position papers
- Identification of an effective communication and access forum for Therapeutic Cell Process and Product Development for registered user access (new), and for ISCT membership-only access
- Online directory of tools and technologies for upstream and downstream processing, serum free media, biopreservation and formulation solutions, as well as final storage containers for cell therapeutics
Key Benchmarks 2011
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At least 2 publications related to Cell Therapy Process & Product Development authored by members Q1 ✓ Q3 |
March, September |
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Launch database of products related to cell therapy processing live on PPD website, upgraded with comments section |
June |
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Develop a plan to increase Bioprocessor membership including a needs assessment and benefit development. |
June |
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At least 4 webinars hosted and chaired by PPD committee members |
December |
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Significant progress in providing guidance and removing ambiguity in area of Potency testing for cell therapy products measured by new educational resources |
December |
Click here to view the upcoming Commercialization Committee webinars
Click here to view the February 8th SBE-ISCT joint webinar recording
