Bioassays and Bioanalytics
Im Auftrag der European Compliance Academy

22-23 June 2016

Copenhagen, Denmark

Seminar Nr. 15524

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Sprecher

Rainer Fedra, VelaLabs, Austria
Markus Fido, VelaLabs, Austria
Tino Galgon, IDT Biologika, Germany
Siegfried Giess, Paul Ehrlich Institute, Germany
Ulrike Herbrand, Charles River Laboratories, Germany

Zielsetzung

The course includes a general discussion of GMP, GLP and GCLP principles and how they apply to potency assays, limits tests, pharmacokinetics, pharmacodynamics and immunogenicity. Furthermore you will learn the principles of phase specific validation as they relate to potency Bioassays and limits tests. We will outline the industry guidelines on PK assays with an emphasis on the accuracy and precision expectations for biopharmaceuticals, including Incurred Sample Reanalysis. The immunogenicity section helps the participants understand important regulatory expectations by a systematic evaluation of critical portions of the EMA guidance. In addition you become acquainted with the specific challenges of transferring Bioassays between laboratories and you get a checklist to identify and overcome the hurdles in the process. Workshops on writing validation protocols provide hands-on experience to cover these pivotal documents. You will also hear case studies that add relevance to the lecture materials and provide a launch point for class discussion.

Hintergrund

The number of biopharmaceutical products is increasing in the clinic and in the market. Their excellent targeting ability is the result of a high complexity that cannot be measured by analytical tests alone. Therefore, the development process of all biopharmaceutical products requires non-analytical tests to fully evaluate their functionality and safety. Biopharmaceutical development is a multi-disciplinary effort that involves many professionals with diverse backgrounds. This course will help team members without the appropriate technical background by clarifying the timelines, requirements and significance of Bioassays-based testing. The types of methods that will be addressed are cell-based assays, immunoassays and molecular assays.

Zielgruppe

Manufacturing process professionals
QA/QC staff and regulatory personnel
Clinical staff, pharmacologists and toxicologists
Project Managers & outsourcing personnel
Analytical chemists and biochemists

Programm

Introduction to Bioassays and Bioanalytical Methods

What is a potency assay?
Product analytics versus Bioanalytics (preclinical & clinical approach)
Why do we need bioassays?
Characterisation of Biopharmaceuticals & Biosimilars

GMP and G(C)(L)P Guidelines (EMA & FDA Overview and Interpretation

Key regulatory guidelines and industry white papers
Life cycle of biopharmaceuticals
Risk assessment

Development I - Selecting Methods and Types of Assays

Assay types
Feasibility
Preparing the cell bank
Optimization parameters
Replacement methods for primary assays
Readouts

Development II – focus on clinical assays (PK/PD/ADA)

Standards and controls
Eliminating edge and hook effects
Setting system suitability criteria

GMP Pre-Validation of Bioactivity (Potency) Assays

Choice of statistical models
Defining and improving intermediate precision
Process controls

GMP Validation Protocol of Bioactivity (Potency) Assays

Guidelines and requirements
Validation parameters
Setting realistic sample specs for validation
Phase specific validation
Validation report

Development of Immunoassays for GCLP Bioanalytics

PK and immunogenicity
DOE versus OFAT

GCLP Validation of Immunoassays with Focus on Bioanalytics

Critical parameters: accuracy, sensitivity & precision
Population cut-point and confirmatory assays
Stability of positive controls in biological matrix
Incurred sample re-analysis

Strategies and Techniques to improve Assays

Improve accuracy and repeatability
Avoid common technical errors

Method Transfer

How to transfer a method?
Transfer tools during product development
Donor and Acceptor
Investigation, calculation and comparison of method parameters

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Bioassays and BioanalyticsIm Auftrag der European Compliance Academy