Recording Online Training: Bioassays and Bioanalytics + Stability Testing for Biological/Biotechnological Drug Substances and Drug Products

Recording Online Training: Bioassays and Bioanalytics + Stability Testing for Biological/Biotechnological Drug Substances and Drug Products

Costs

ECA-Member: EUR 2180,--
Non ECA Member: EUR 2380,--
EU/GMP Inspectorates: EUR 1190,--
APIC Member Discount: EUR 2280,--

(All prices excl. VAT)

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

Speakers

Dr Jörg Engelbergs, Paul Ehrlich Institute, Germany
Rainer Fedra, VelaLabs, Austria
Dr Markus Fido, MFi Bio-Consulting
Dr Ulrike Herbrand, Charles River Laboratories, Germany
Dr Michael Leiss, Roche, Germany

Programme

Live Online Training: Bioassays and Bioanalytics
 
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
Case Studies on Special Bioassays for Biopharmaceuticals and Biosimilars
  •  ADCC/CDC
  •  RBA mAb
Method Transfer
  •  How to transfer a method?
  •  Transfer tools during product development
  •  Donor and  Acceptor
  •  Investigation, calculation and comparison of method parameters
 
Live Online Training: Stability Testing for Biological/Biotechnological Drug Substances and Drug Products

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
Study Design, Impurities and Stability Specifications

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

Duration of the Recording: Appr. 15 h 40 min

Recording from 20, 21 and 22 October 2020

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