BIOASSAY

A client looking to submit a Biologics License Application (BLA) to the FDA approached us requiring assurance that two in-house potency bioassays were sufficiently validated. These bioassays were associated with the production and characterization of all batches of a novel biological drug used in pre-clinical and clinical testing.

Quantics

• Reviewed the validation methodology and the resulting assay acceptance criteria
• Reviewed the validation reports
• Suggested improvements to data analysis to make optimal use of all data collected

 Benefits for the client were:

• Areas that did not comply with current and proposed regulations for bioassay validation (ICH, US Pharmacopeia and European Pharmacopoeia) were highlighted
• In-house resources were able to focus on their priorities for BLA submission whilst Quantics performed the independent review
• Optimised experimental and analytical design that
  -  Made more use of data already being collected
  -  Resulted in reduced variation and increased assay precision, accuracy, range, linearity and robustness

The client did not need to repeat the validation process and delay the license application. The client has since been bought by a major pharmaceutical company.