Multiparametric Approach to Quality by Design (QbD)

Multiparametric Approach to Quality by Design (QbD)Using living cells provides a more physiological response. A challenge in designing and executing cell-based assays is identifying and controlling variability. As living entities, cells sense and respond to their environment. Simple manipulations can cause them to change their properties. A poorly controlled assay can cause an manufacturing process to appear out of control or result in invalid or re-test scenarios. QbD decreases the product risk and increases process knowledge using a scientific framework.

Flow cytometry can provide multiparametric data at single-cell resolution enabling simultaneous monitoring of Critical Method Parameters (CMAs) and interrogating complex interrelated responses. Assessing cellular responses on multiple levels can lead to more efficient identification of CQAs.

One factor at a time (OFAT, panel A) versus the multifactorial Design Of Experiment (DoE, panel B) better identifies efficient design space for QdB analysis..


One factor at a time (OFAT, panel A) versus the multifactorial Design Of Experiment (DoE, panel B) better identifies efficient design space for QdB analysis.

 

Flow Cytometry Assays

At Beckman Coulter Life Sciences, our flow cytometry division has been developing flow cytometry assays for highly regulated clinical diagnostic testing. Our knowledge of robust assay design and a focus on the workflow positions us as a strong partner for developing flow cytometry-based solutions for complex cell-based assays. Mitigating sources of variability begins during assay design, continues during QbD analytical method development, and through process monitoring. 

We are committed to providing tools to improve the quality of data used to make critical decisions in process development through to batch release testing. 

  • Reduce labor intensive administrative tasks
  • Reduce pipetting errors and reagent inventory management
  • Facilitate compliance with quality system and regulatory requirements
  • Reduce subjectivity in data analysis and manage data securely

Flow Cytometry Assays by Development Stage and Regulatory Framework

Drug Discovery Non-clinical Testing Clinical Testing
Non-Regulated
Target identification
Mechanism of action
Biomarker identification

GLP
Drug toxicity
Pharmacodynamic (PD) biomarker
Pharmacokinetics
Immune monitoring
Receptor occupancy analysis

GMP
Potency and batch lot release

IVD or CLIA
Drug safety and efficacy
Companion diagnostics

GLP
Pharmacokinetics/immunogenicity
Pharmacodynamic (PD) biomarker

GMP
Potency and batch lot release

Products

DuraClone dry flow cytometry reagents in rack

DURA Innovations

Standardized dry antibody panels for comprehensive immunophenotypic characterization of source materials.

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