Bioassays and Bioanalytics + Stability Testing for Biological/Biotechnological Drug Substances and Drug Products

Bioassays and Bioanalytics + Stability Testing for Biological/Biotechnological Drug Substances and Drug Products

Copenhagen, Denmark

Course No 17014


Costs

Non ECA Member: EUR 2280,--
ECA-Member: EUR 2080,--
EU/GMP Inspectorates: EUR 1140,--
APIC Member Discount: EUR 2180,--

(All prices excl. VAT)

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

Speakers

Dr Jörg Engelbergs, Paul-Ehrlich-Institut, German Federal Agency for Vaccines and Biomedicines
Rainer Fedra, VelaLabs, Austria
Dr Markus Fido, VelaLabs, Austria
Dr Ulrike Herbrand, Charles River Laboratories, Germany
Dr Michael Leiss, Roche Diagnostics, Germany
Dr Manuela Leitner, AGES, Austria

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 documents
GMP & G(C)(L)P Guidelines (EMA & FDA)
  • Overview and Interpretation
Development of Bioactivity / Potency Assays – selecting methods and types of assays
  • Assay Types
  • Feasibility
  • Preparing the Cell Bank
  • Optimization Parameters
  • Replacement methods for primary assays
  • Readouts
Development of Immunoassays for GCLP Bioanalytics
  • Standards and controls
  • Eliminating edge and hook effects
  • Setting system suitability criteria
Strategies and techniques to improve assays
  • Improve accuracy and repeatability
  • Avoid common technical errors
Statistical Analyses & Trending

Development of clinical assays (PK/PD/ADA) 

GMP Validation of Bioactivity (Potency)  Assays
  • Guidelines and Requirements
  • Validation Parameters
  • Setting Realistic Sample Specs for Validation
  • Phase Specific Validation
  • Validation Report
DOE
  • DOE versus OFAT
Workshops Session
  • Validation Workshop for Bioactivity (Potency) Bioassays
  • Validation Workshop for PK/PD and Immunogenicity Assays
Method Transfer
  • How to transfer a method?
  • Transfer tools during product development
  • Donor and  Acceptor
  • Investigation, calculation and comparison of method Parameters
Stability Testing of Biological and Biotechnological Drug Substances and Drug Products
  • Biologicals and relevant guidelines
  • Specific differences between chemical entities and biologicals
  • Stability-indicating profile of Monoclonal Antibodies and Immunoglobulins
  • Storage conditions
  • Impact of changes on stability
  • Submitting stability data within the CTD structure
Stability studies and shelf-life determination, starting activities and study report
  • Prerequisites for performing a stab study
  • Concepts for study design and reporting
  • Start, study performance and study closing
  • Regulatory aspects during product development
  • Objectives for a final stab study report
Stability Studies beyond Lot Stability
  • Selection of appropriate, sensitive methods
  • Analysis of stressed samples
  • Statistical interpretation of shifts and drifts
  • Acceptance limits
Degradation of Polysorbate
  • Mechanisms of Polysorbate degradation
  • Consequences of Polysorbate degradation
  • Analytical tool box for degradation assessment
Stability requirements of the new Guideline on Quality Documentation Concerning Biological Investigational Medicinal Products in Clinical Trials
  • Control of excipients
  • Specifications, batch analysis
  • Stability data
  • Shelf-life determination
  • Post approval extension
  • Substantial amendments
Workshop I: Study Design, Impurities and Stability Specifications
Workshop II: Potency Assays

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