Building a Better Assay

Bioassay Sciences is an internationally recognized scientific and engineering consulting firm targeted on design, support and validation of bioassays. We use a platform approach to rapid bioassay development, systems suitability, parallelism and control. We are a strategic partner of SAS and JMP statistical software. We have years of experience in the bioassay space and have worked with clients and regulatory agencies to achieve results in bioassay design and validation.

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Our Services

Training

Training

Complete training solution for bioassay development, design and validation. Training curriculum is custom tailored to the specific needs of your company.

Consulting

Consulting

Consulting services in bioassay design, statistical modeling, validity criteria, quantitation, scripting, stability monitoring, validation, tracking and trending, data automation as well as FDA/agency support.

Scripting

Scripting

Platform script customization, script validation, and other custom JMP scripting services in JSL (JMP Scripting Language).

Maintenance

Maintenance

We offer custom services depending on your needs to help you maintain bioassay projects.

Bioassay Sciences Platform

BAS has been able to develop a platform approach to bioassays, due to our extensive experience in developing bioassays. This allows the client to quickly determine the number of dilutions, dose/response, signal detection and then use our validity criteria and SAS/JMP based scripts. A platform approach to bioassays speeds up the development timeline and simplifies the validation.

  1. Bioassay Calculator Design (USP 1032, 1033 and 1034 aligned)
    • Dose/ response and dilution scheme
    • Statistical tests and parallelism
    • Calculator design and confidence intervals
    • Outlier and masking protocol
    • Curve weighting
    • Calculator development report
  2. System Suitability, Validity & Reference Controls
    • System suitability acceptance criteria
    • New reference correction factor and SOP
    • Reference stability correction factor and SOP
    • Bioassay monitoring and tracking and trending
    • Plate reader control strategy
  3. Automated Data Management & Report Generation
    • Data management and LIMS interface
    • SAS/JMP based Data Analysis
    • Automated report generation and tracking and trending of assay and standards
    • Potency calculator and SAS/JMP validation services and report
  4. Analytical Method & Bioassay Validation (USP 1033 aligned)
    • Phase appropriate pre-validation and validation and acceptance criteria
    • Robustness
    • Specificity
    • Repeatability and intermediate precision
    • Accuracy / bias and relative bias
    • Linearity and Range

Bioassay Validation 1033 Aligned

BioAsssy Sciences provides consulting support on study design, report generation and full agency support.

  • Dilutional Linearity and Validation Study Design
  • Sample Size and Power Determination
  • Accuracy/Bias
  • Repeatability
  • Intermediate Precision Study Design
  • Robustness Study Design and Risk Assessment
  • Range
  • Linearity
  • Specificity
  • Bioassay data analysis and validation report generation

Our Mission

Platform Approach

Work with clients to provide a platform approach for modern bioassay design and report generation.

Reduce Variation

Reduce variation due to poor calculation and data handling (15-20%).

Reduce Invalids

Reduce invalid and OOS rate due to poor calculator design.

Modern Approach

Use modern statistical approaches, USP 1032/1034 aligned to relative potency determination.

Reduce Cost

Lower the cost of ownership (over SAS and other software) and maintenance of bioassays.

Improve Automation

Improve automation, data generation and tracking and trending/control of bioassays.

Simplify Process

Simplify the development, automation, reports and software validation of bioassays.

Increase Speed

Increase the speed of development by using a platform approach and modular code.

Improve Monitoring

Dramatically improve bioassay monitoring, control and tracking and trending.

Other Services Offered from Bioassay Sciences

  • Bioassay and General Statistical Training (SAS/JMP based)
  • Standard Operating Procedures for Bioassays
  • General Consulting Services
  • FDA and Health Authority Support
  • Bioassay Validation
  • SAS/JMP Validation
  • Bioassay Script Validation

Benefits of Our BioAssay

Cost Effectiveness

Lower development cost. OOS and invalid reduction. Lower cost of maintenance, validation, tracking and trending.

Rapid Development

10-20 days from assay request to delivery of assay.

Performance

10-25% reduction in variation compared to other platforms.

Productivity

Automated reporting and data handling, customized assay on an easy to validate platform, automated performance monitoring and data availability.

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Our Consultants

Our consultants are experts in JMP, Minitab and process flow and control analytical software products. We have trained over 85,000 engineers and scientists on the use of statistical and analytical methods for product/product characterization, improvement and control with operations in the US, Canada, Asia Pacific and Europe.

Thomas A. Little

President and Principal Consultant

Dr. Thomas A. Little is President of Thomas A. Little Consulting (TLC) an internationally recognized consulting firm with a proven record for achieving results.

Daniel Harding

Lead Consultant

Daniel is a statistician with experience in the diagnostic, medical device, and biotech industries. He has helped teams in product development, optimization, CAPA, bioassays, and other critical areas.

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