Custom Assay Kits
In addition to standard assay kits, Accellix develops custom assay kits tailored for specific cell therapy manufacturing workflows, including drug-release assays.
Coupled with automated and customizable analysis algorithms that dynamically classify cell subsets for each run, critical quality attributes of cell products can be easily measured for real-time monitoring and decision making.
Measure critical quality attributes of the cell product at every step, from patient sample acquisition to drug product release
The Accellix platform has been embraced by leading immunotherapy companies as it enables streamlining of cell phenotyping and enumeration during analytical and process development as well as manufacturing and QC of cell therapy drug products.
Custom Assay Development Process
Typical timeline is 4-6 months depending on assay complexity and customer feedback.
Development
- Define assay requirements
- Design fluorophore panel and acquire reagents
- Develop and optimize formulation and protocol
- Verify performance using customer-supplied cell sample
Optimization
- Evaluation at customer site under use-case conditions
- Customer feedback
- Optimization of formulation if needed
- Lock-down formulation and protocol
Transfer and Release
- Establish assay kit QC criteria
- Arrange cell supply for production
- Manufacturing transfer
- Release to customer for assay validation
STANDARD ASSAY KITS
The Accellix Platform automates your entire GMP cell phenotyping process from sample preparation to data acquisition and analysis, to generate rapid results directly in the manufacturing suite.
Standard Assays