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

Datum und Zeit26.10.2021 - 28.10.2021


In Kalender übernehmen


Kosten / Gebühren2.180,00




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. Workshops 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


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

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.

Technical Requirements

For our Live Online Training Courses and Webinars, we use Cisco WebEx, one of the leading suppliers of online meetings.

At 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.


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 versus OFAT

Case Studies on Special Bioassays for Biopharmaceuticals and Biosimilars

* 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

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


TeilnehmerkreisZielgruppe * Manufacturing process professionals * QA/QC staff and regulatory personnel * Clinical staff, pharmacologists and toxicologists * Project managers & outsourcing personnel * Analytical chemists and biochemists

VeranstalterConcept Heidelberg GmbH
Rischerstr. 8
69123 Heidelberg

Telefon: +49 6221 84 44 0
Telefax: +49 6221 84 44 84

OrganisatorTel.: 06221 / 84 44 0

DirektlinkZur Veranstaltung