Alexander Doppelreiter
Conscio Pharma Austria
Referierende
Klemens Weitenthaler
Conscio Pharma Austria
Dr Manuel Hafner
Patheon Austria
Dr Sophie Fröhlich
Takeda
With an Exercise about the Standardization in the Validation of Bioassays
- End-to-End Lifecycle Approach
- Bioassays & Potency in Focus
- Bridging Classical and Modern Technologies
Zielgruppe
This training is aimed at the following employees:
- Heads and Managers of QC / Analytical Development
- QA Managers and Qualified Persons (QPs)
- Scientists and Project Leads in Bioanalytics and Method Validation
- Experts responsible for Bioassays, Potency Testing and Reference Standards
- Professionals working with automated or digital QC Systems
- Regulatory Affairs specialists involved in CMC and analytical dossiers
- Specialists from biotechnology companies developing proteins, mAbs and ATMPs
Zielsetzung
In biotechnology, analytical method validation is no longer limited to demonstrating accuracy, precision and specificity at a single point in time. Current regulatory frameworks, such as EudraLex Volume 4 and the lifecycle approach described in USP <1220>, as well as the risk management principles of ICH Q9, require a science- and risk-based control strategy that covers the entire analytical lifecycle, from development and validation to ongoing performance verification, change control, and data governance.
Additionally, the growing regulatory focus on bioassays, potency testing, reference standard qualification, computerised systems and data integrity (ALCOA+) has significantly raised expectations during inspections. The growing use of automation, digital data platforms and modern analytical technologies (e.g. CE-SDS, ICIEF and LC-MS) further increases the complexity of validation concepts in biotechnology environments.
Against this background, companies must ensure that their analytical validation strategies are scientifically justified, risk-based, inspection-ready, and aligned with global regulatory expectations.
During this seminar, participants will learn how to translate regulatory requirements into practical and defensible validation strategies for biotechnology products. They will learn how to define performance characteristics that align with CQAs and the intended method of use; how to establish scientifically justified acceptance criteria; and how to assess method suitability prior to validation.
They will also learn how to validate classical protein analytical methods such as SDS-PAGE, Western blot and IEF under GMP, how to integrate modern alternatives such as CE-SDS, icIEF and LC-MS, and how to bridge the gap between technologies in a compliant manner. The seminar will also address the specific challenges of bioassay and potency assay validation, including cell-based assays and applications in advanced therapy medicinal products.
Additionally, the growing regulatory focus on bioassays, potency testing, reference standard qualification, computerised systems and data integrity (ALCOA+) has significantly raised expectations during inspections. The growing use of automation, digital data platforms and modern analytical technologies (e.g. CE-SDS, ICIEF and LC-MS) further increases the complexity of validation concepts in biotechnology environments.
Against this background, companies must ensure that their analytical validation strategies are scientifically justified, risk-based, inspection-ready, and aligned with global regulatory expectations.
During this seminar, participants will learn how to translate regulatory requirements into practical and defensible validation strategies for biotechnology products. They will learn how to define performance characteristics that align with CQAs and the intended method of use; how to establish scientifically justified acceptance criteria; and how to assess method suitability prior to validation.
They will also learn how to validate classical protein analytical methods such as SDS-PAGE, Western blot and IEF under GMP, how to integrate modern alternatives such as CE-SDS, icIEF and LC-MS, and how to bridge the gap between technologies in a compliant manner. The seminar will also address the specific challenges of bioassay and potency assay validation, including cell-based assays and applications in advanced therapy medicinal products.
Programm
GMP Expectations for Protein Analytical Methods
- Regulatory baseline: EudraLex Vol. 4 and USP analytical lifecycle requirements
- Definition of performance attributes aligned with CQAs and intended use
- Assessment of method suitability as a prerequisite for Validation
- Scientifically justified acceptance criteria for qualitative and quantitative methods
- Ongoing method performance: system suitability, trending, and change control
From Data to Risk to Validation – Quantifying Variability, Safeguarding Decisions, Statistics and Simulations in the GMP Environment
- Why “from data to risk”?
- Understand variability & structuring it for action
- From data view to risk analysis (ICH Q9 / risk-based thinking)
- Risk quantification and simulation as a reusable toolbox
Reference Substances – Characterization, Handling, Stability and much more
- Types of reference substances (Ph. Eur. CRS, primary and working standards, impurity standards)
- Scientific characterization and content assignment
- Traceability, uncertainty, and regulatory expectations
- GMP-compliant handling and lifecycle Management
- Stability considerations and re-qualification strategies
- Common inspection findings and practical pitfalls
Automated Systems & Robot-Assisted Workflows: Validation and Challenges
- Why automation in QC is no longer a “nice-to-have”
- Regulatory expectations/requirements
- What makes automated workflows particularly critical
- Validation of automated systems – what is different?
- Challenges and best practice
- Outlook for the future – AI, remote and cloud
Validation of Bioassays - Common Pitfalls and How to Avoid them
- Validation principles and the different assay formats
- Regulatory background for potency assay evaluation
- Statistical evaluation, combination of assay results and assessing parallelism
- Potency testing for cell and gene therapy products
Mastering the Methods: In-house Standards & Validation Across the Lifecycle
- Holistic control strategy across the full method Life Cycle
- Risk-based change control and requalification
- Digital Method File as a single source of truth
- Knowledge management (lessons learned) plus global harmonization via consistent in-house standards across sites
GMP Validation of Classical Protein Methods and Modern Alternatives
- GMP role of SDS-PAGE, Western Blot, and IEF in identity, purity, and heterogeneity testing
- Validation challenges specific to gel- and blot-based methods under GMP
- Control strategies: reference standards, system suitability, and reproducibility
- Integration of modern techniques (CE-SDS, icIEF, LC-MS) and regulatory bridging
Smart Evaluation, Safe Compliance: Digital Data Evaluation with Validation & Data Integrity at the Core (ELISA/Potency/LC-MS)
- Ensure ALCOA+ in semi-automated workflows from sample to decision (process-first, not tool-first)
- Implement digital concepts for evaluation and validation, including a centralized data lake/lab data hub for bioanalytics
- Establish governance for central data platforms across the full data lifecycle, plus end-to-end change management (technical to regulatory)
- Capture practical learnings: typical pitfalls and how to avoid them
Interactive Session - The Importance of Standardization in the Validation of Bioassays
- Strategies for identifying and reducing assay variation
- How To: Transfer of cellbased potency assays
- The role of reporter gene assays as part of the release portfolio
Weitere Informationen
Technical Requirements
We use Webex 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 events 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.
Fees (per delegate plus VAT)
ECA Members € 1,890
APIC Members € 1,990
Non-ECA Members € 2,090
EU GMP Inspectorates € 1,045
The conference fee is payable in advance after receipt of invoice.
Presentations/Certificate
The presentations will be made available to you prior to the Live Online Training as PDF files. After the event, you will automatically receive your certificate of participation.
Conference language
The official conference language will be English.
Contacts
Questions regarding content:
Mr Clemens Mundo (Operations Director), +49 6221 84 44-42, mundo@concept-heidelberg.de
Questions regarding organisation:
Ms Sonja Nemec (Organisation Manager), +49 6221 84 44-24, nemec@concept-heidelberg.de.
Datum & Uhrzeiten
Wed, 01 July 2026, 9:00 – 15:30 h
Thu, 02 July 2026, 9:00 – 13:00 h
All times mentioned are CEST
Thu, 02 July 2026, 9:00 – 13:00 h
All times mentioned are CEST
Teilnahmegebühr
| ECA-Member*: | € 1890,- |
| Non ECA Member*: | € 2090,- |
| EU/GMP Inspectorates*: | € 1045,- |
| APIC Member Discount*: | € 1990,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
Aufzeichnung/weitere Termine nicht verfügbar
Aufzeichnung/weitere Termine nicht verfügbar
Haben Sie noch Fragen?
Wir stehen Ihnen für weitere Auskünfte gerne zur Verfügung.
E-Mail: info@concept-heidelberg.de
Teilnehmerstimmen
Teilnehmerstimmen - das sagen andere über unsere Seminare:
