Bioassays and Bioanalytics

Bioassays and Bioanalytics

Copenhagen, Denmark

Course No 16210


Costs

This conference already took place.

If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@gmp-compliance.org

Speakers

Rainer Fedra, VelaLabs, Austria

Markus Fido, VelaLabs, Austria

Ulrike Herbrand, Charles River Laboratories, Germany

Dr Manuela Leitner, AGES, Austria

Dr. Norbert Nagel, Sanofi- Deutschland

Objectives

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.

Background

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.

Target Group

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

Programme

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
  • Regulatory Expectations and Requirements on Bioassays and Bioanalytical Methods
  • Introduction and general aspects
  • Bioassays and methods – expected data
  • Guidance document
s
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
Workshops Session
1. Validation Protocol Workshop for Bioactivity (Potency) Bioassays
2. Validation Protocol Workshop for PK/PD and Immunogenicity Assays


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

Go back

GMP Conferences by Topics

Cookies help us in providing our services. By using our services, you agree that we use cookies. Further information

OK