All times mentioned are CEST.
Objectives
Bioassays and Bioanalytics
The Live Online Training includes a general discussion of GMP, GLP and GCLP principles and how they apply to potency assays, limits tests, pharmacokinetics, pharmacodynamics and immunogenicity. Furthermore you will learn the principles of phase specific validation as they relate to potency Bioassays and limits tests. We will outline the industry guidelines on PK assays with an emphasis on the accuracy and precision expectations for biopharmaceuticals, including Incurred Sample Reanalysis. The immunogenicity section helps the participants understand important regulatory expectations by a systematic evaluation of critical portions of the EMA guidance. In addition you become acquainted with the specific challenges of transferring Bioassays between laboratories and you get a checklist to identify and overcome the hurdles in the process. Case studies on writing validation protocols provide hands-on experience to cover these pivotal documents. You will also hear case studies that add relevance to the lecture materials and provide a launch point for class discussion.
Stability Testing for Biological/Biotechnological Drug Substances and Drug Products
During this Live Online Training you will get to know the relevant aspects of stability testing for biological and biotechnological drug substances and drug products. You will learn about
- the basic requirements of stability testing and stability study design from the supervisory authority’s view,
- the peculiarities of stability indicating analytical methods,
- optimising strategies regarding packaging and storage of biological/biotechnological material,
- how to submit stability data for a marketing authorisation dossier according to the new Guideline on Quality Documentation.
Background
Bioassays and Bioanalytics
The number of biopharmaceutical products is increasing in the clinic and in the market. Their excellent targeting ability is the result of a high complexity that cannot be measured by analytical tests alone. Therefore, the development process of all biopharmaceutical products requires non-analytical tests to fully evaluate their functionality and safety. Biopharmaceutical development is a multi-disciplinary effort that involves many professionals with diverse backgrounds. This course will help team members without the appropriate technical background by clarifying the timelines, requirements and significance of Bioassays based testing. The types of methods that will be addressed are cell-based assays, immunoassays and molecular assays.
Stability Testing for Biological/Biotechnological Drug Substances and Drug Products
Stability Testing for Biological/Biotechnological Drug Substances and Drug Products
The active components in biotechnological/biological products are typically proteins and/or polypeptides. They have distinguishing characteristics to which consideration should be given in any well-defined testing program designed to confirm their stability during the intended storage period. The products are particularly sensitive to environmental factors such as temperature changes, oxidation, light, ionic content, and shear. In order to ensure maintenance of biological activity and to avoid degradation, stringent conditions for their storage are usually necessary.
The evaluation of stability may necessitate complex analytical methodologies. Appropriate physicochemical, biochemical and immunochemical methods for the analysis of the molecular entity and the quantitative detection of degradation products should also be part of the stability program.
In order to get the approval to conduct a clinical trial data have to be presented on the biological, chemical and pharmaceutical quality of Investigational Medicinal Product (IMP). In the new Guideline on the Requirements for Quality Documentation Concerning Biological Investigational Medicinal Products in Clinical Trials particular provisions are laid down on how to document stability and other quality related data within the CTD structure.
The evaluation of stability may necessitate complex analytical methodologies. Appropriate physicochemical, biochemical and immunochemical methods for the analysis of the molecular entity and the quantitative detection of degradation products should also be part of the stability program.
In order to get the approval to conduct a clinical trial data have to be presented on the biological, chemical and pharmaceutical quality of Investigational Medicinal Product (IMP). In the new Guideline on the Requirements for Quality Documentation Concerning Biological Investigational Medicinal Products in Clinical Trials particular provisions are laid down on how to document stability and other quality related data within the CTD structure.
Target Group
- Manufacturing process professionals
- QA/QC staff and regulatory personnel
- Clinical staff, pharmacologists and toxicologists
- Project managers & outsourcing personnel
- Analytical chemists and biochemists
Technical Requirements
We use WebEx Events for our live online training courses and webinars. At https://www.gmp-compliance.org/training/online-training-technical-information you will find all the information you need to participate in our trainings and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT 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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Tel.: +49 6221 8444-0
E-Mail: info@gmp-compliance.org
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