Method Development and Validation for Assays Supporting Testing of Biologics training seminars presented by ComplianceOnline register now on FindaSeminar.com

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Method Development and Validation for Assays Supporting Testing of Biologics  

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

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Seminar Summary:

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. (see full course description)

 

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Training Course Syllabus:


Method Development and Validation for Assays Supporting Testing of Biologics

Course 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

DAY 01(8:30 AM - 4:30 PM)

Registration Process: 8:30 AM – 9:00 AM
Session Start Time: 9:00 AM
Overview of Biologics and Biotechnology
Differences between small molecule and large molecule therapeutics
Assays required for biologics
Timelines
Regulatory guidances
GxP in biologics
Analytical CMC methods and bioassays
Assays supporting product development, release, and stability
Portfolio of required assays
Mechanism of action and potency methods
Selection of potency-indicating method(s)
Assay formats/platforms
Consideration of reagents, endpoints, signal to background
Standardizing cell culture procedures
Understanding and managing assay variability
Overview of feasibility to validation
Early development - feasibility
Use of DOE
Involvement of statisticians
Development and final development
Optimizing the assays
Validation of cell-based methods

DAY 02(8:30 AM - 4:30 PM)

Assays supporting preclinical and clinical studies
Regulatory guidance
Assay platforms
Reagents, endpoints, signal to background
Method development
Assessing matrix effects
Method optimization
Validation parameters
Incurred sample reanalysis
Immunogenicity methods
Screening methods
Confirmatory methods
Neutralizing antibody method
Biomarker validation
Written procedures (methods, protocols, SOPs)
Analyst training
Maintaining quality in-house and in outsourcing

Seminar Summary:

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. (see full course description)

print this agenda print agenda for the Method Development and Validation for Assays Supporting Testing of Biologics training seminar

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