Sprecher
Rainer Fedra, VelaLabs, Austria
Dr Markus Fido, MFi Bio-Consulting
Dr Ulrike Herbrand, Charles River Laboratories, Germany
Dr Michael Leiss, Roche, Germany
Technical Requirements
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Programm
- What is a potency assay?
- Product analytics versus Bioanalytics (preclinical & clinical approach)
- Why do we need bioassays?
- Characterisation of Biopharmaceuticals & Biosimilars
- Introduction and general aspects
- Bioassays and methods – expected data
- Guidance documents
- Overview and Interpretation
- Assay Types
- Feasibility
- Preparing the Cell Bank
- Optimization Parameters
- Replacement methods for primary assays
- Readouts
- Standards and controls
- Eliminating edge and hook effects
- Setting system suitability criteria
- Improve accuracy and repeatability
- Avoid common technical errors
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 versus OFAT
- ADCC/CDC
- RBA mAb
- 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
- 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
- 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
- Control of excipients
- Specifications, batch analysis
- Stability data
- Shelf-life determination
- Post approval extension
- Substantial amendments
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Tel.: +49 6221 84 44 0
E-Mail: info@concept-heidelberg.de
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