Advantages of Cellular Starting Material Characterization for Allogeneic Cell Therapy Applications: Impacts to Downstream In-Process Cell Therapy Adaptive Manufacturing
Description: The presenters provide a CDMO perspective for how the Accellix Platform is advantageous across allogeneic cell therapy and RUO product manufacturing workflows, enabling data-driven decision-making, from starting material sourcing through to product release:
Starting Material Screening
- Upfront donor screening and starting material characterization is essential to address a primary source of variability in allogeneic manufacturing.
- Defining critical material attributes (e.g., minimum CD3% population, CD4/CD8 ratio, restrict NK impurities) allows developers to apply smart selection of starting material and set go/no-go guidance for leukopak downstream use.
- Screening creates a “donor to dose” understanding, linking donor biology to process performance, product yield, and clinical outcomes.
- Excellos’ E360 platform uses multiparametric analysis (metabolic fitness, effector potential, stemness, and memory potential) to address variability in patient outcomes driven by donor biology.
- By pairing the Accellix Platform with these analytical frameworks, developers can identify superior starting materials, reduce manufacturing costs, and improve clinical success rates.
In-Process Monitoring
- Accellix enables rapid characterized leukopak inputs during autologous CAR-T manufacturing that can feed directly into systems like the CliniMACS Prodigy, eliminating the 3-hour traditional flow cytometry hold.
- Providing these in-process parameters earlier, ideally at the point of collection on a certificate of analysis, can remove hold times entirely, prevent idle clean-room operators, reduce QC-related errors or delays, and lower overall risk of manufacturing failure.
QC Release
- Accellix enables rapid characterization during the development of donor-derived, purified cell isolate products (e.g., CBU-derived CD34+ isolates).
- Supports QC release testing to confirm purity levels for research-use products.
- Requires only minimal sampling, preserving valuable low-volume final material.
The vision for successful cell therapy programs relies on deeper, upfront characterization of starting material, integrating immunophenotyping, functional fitness, and demographic data to improve yield, product quality, and alignment between manufacturing outcomes and clinical response. Achieving this vision depends on close strategic collaboration with blood collection experts who provide and characterize the cellular starting materials.
