Live Online Training: Bioassays and Bioanalytics + Stability Testing for Biological/Biotechnological Drug Substances and Drug Products
Im Auftrag der ECA Academy

Live Online Training: Bioassays and Bioanalytics + Stability Testing for Biological/Biotechnological Drug Substances and Drug Products Im Auftrag der ECA Academy

Seminar Nr. 18336


Kosten

Die Anmeldung ist nicht mehr möglich. Bitte setzten Sie sich mit uns in Verbindung, wenn Sie eine Aufzeichnung bestellen möchten:

Rückfragen unter:
Tel.: 06221 / 84 44 0 E-Mail: info@concept-heidelberg.de

Sprecher

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

Technical Requirements

For our webinars, we use Cisco WebEx, one of the leading suppliers of online meetings.

At http://www.webex.com/test-meeting.html you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in.  Please just enter your name and email address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.

Programm

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

Zurück

GMP Seminare nach Thema

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