Dr. Marcus Fido
Mfi Bio-Consulting
Live Online Training - Bioassays and Bioanalytics + Stability Testing for Biological/Biotechnological Drug Substances and Drug Products
Speakers
Dr. Jörg Engelbergs
Paul-Ehrlich-Institut
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.
Programme
Seminar Programme as PDF
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
Degradation of Polysorbate
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
This course is part of the GMP Certification Programme "ECA Certified Quality Control Manager" Learn more
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To find alternative dates for this training/webinar or similar events please see the complete list of all events.
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Do you have any questions?
Please contact us:
Tel.: +49 6221 8444-0
E-Mail: info@gmp-compliance.org
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