Rapid Development & Productivity

Rapid and Cost Effective BioAssay Development

BioAssay Sciences Platform allows for rapid and cost effective BioAssay Development. The typical BioAssay Timeline is less than 20 days after a dose scheme, standard, control and plate map have been clearly defined.

BioAssay Criteria & Finalization
2-5 Days

Platform Script Customization
10 - 15 Days

BioAssay Development Report
2-5 Days

Script Validation and Report
2-5 Days

Bioassay validation and reference stability monitoring

Common BioAssay Complaints

Variation

Excessive variation and OOS due to poor calculator design

Invalids

Excessive invalids due to poor calculator design

Outliers

Lack of control over outliers and masking

Control

Lack of control over reference and equivalence testing for parallelism

Management

Poor data management and LIMS integration

Restrictions

Restrictions in bioassay development due to software limitations

Slow

Slow development timeline

Cost

Excessive cost of ownership

Regulatory Alignment

Regulatory alignment is often poor

Advantages of using Our Platform

  • SAS / JMP Based, no additional software to purchase or learn
  • Ease of development, platform approach
  • Outlier analysis and point removal
  • Masking protocol for dose saturation
  • Curve weighting
  • Best statistical tools and concepts
  • Data automation and report generation
  • Ease of change and maintenance
  • Automated tracking and trending of reference and assay performance
  • Systems suitability and validity
  • Parallelism evaluation using equivalence testing and ratios
  • Parallelism using hypothesis tests (as appropriate)
  • Effective evaluation of parallelism using constrained-unconstrained relative potency
  • Reduce assay error due to poor calculator design
  • Fully automated solutions from SoftMax file to PDF report to LIMS
  • Overcome the limitations of SoftMax and PLA in Potency determination

Phase Appropriate BioAssay Development

During each phase of product development the bioassay also needs to be developed, pre-validated (qualified) and subsequently validated. BAS bioassay solutions allows for a smooth and simple approach to development and validation.

  1. Pre-Clinical and Phase I
    • Dose response, calculator design, method development
    • Control design and plate layout
    • Select reference standard and control, build foundation SAS/JMP Script
  2. Phase II
    • Finalize dose, calculator and system suitability
    • Robustness, Specificity and Pre-validation
    • Finalize SAS / JMP Script, start tracking and trending
  3. Phase III and Commercial
    • Validated Bioassay and Script
    • Control of reference and reference stability
    • Tracking and trending

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