Conference Description:

Biologics continue to be a steadily growing component of the pharmaceutical industry. The advent of large molecule therapeutics requires a different perspective on the assays needed to support development through preclinical and clinical testing.

This 2-day seminar is designed to offer a broad overview of developing and validating a range of assay methodologies for biologics with specific key analysis of cell culture, assay variability, and DOE. Specifically, this seminar covers essential concepts related to cell-based potency methods, ELISA, and other methods supporting biologics. In addition to potency methods this seminar addresses immunogenicity methods for preclinical and clinical studies. The format of the seminar offers an examination of current best practices as well as time to dissect examples of documentation with emphasis on beneficial systems to consider. Scientists who attend this 2-day seminar will gain knowledge that will be beneficial in helping to achieve well-controlled validated methods.
Learning Objectives:
Understanding the different requirements for small versus large molecules
Mapping appropriate timelines with decision points
Designing, developing, optimizing, and validating key methods
Potency methods, other release and stability methods
Preclinical and clinical methods
Use of DOE and statistical analysis
Handling of critical materials
Process monitoring concepts
Assessment of orthogonal methods
Assessing readiness for validation
Defining the validation protocol with real-time capture of data analysis
Maintaining quality through documentation
Who will Benefit:
Below titles working in biopharmaceuticals, pharmaceuticals, natural products/botanicals will be benefited by attending this seminar:

Validation Scientists
QA/QC
Regulatory Affairs
Laboratory Managers
Assay Development Specialists
Statistician
CMC Titles
Bio Assay