ATMP - Hurdles and Achievements in Quality and Safety
24/25 March 2026, Wiesbaden/Germany
Objectives
The conference will address a range of manufacturing challenges, including GMP regulations, as well as quality control issues. It will also explore appropriate ways to maintain, assure and control the expected quality. Experienced speakers from the field of ATMP will explain the latest developments, current requirements and report on their experiences during inspections and the implementation in the company.
Background
Modern systems of regenerative medicine, such as cells and tissues or ATMPs (gene therapeutics, somatic cell-based products and tissue-based products), represent an innovative group of drugs that is becoming increasingly important. Following the entry into force of several regulatory guidelines, such as the European Directive 2007/1394/EC for ATMPs, these products were classified as medicinal products. Consequently, they must comply with the EU's requirements for medicinal products. Despite the biopharmaceutical industry's significant expansion in this field, many of these products are still developed and manufactured at universities, hospitals and in small and medium-sized enterprises. These university or medical roots lead to special challenges for the respective institutions as well as for the regulatory authorities in fulfilling the compliance requirements for quality, safety and GMP aspects and approval. This is also driven by the frequent occurrence of manufacturing conditions, such as the open manipulation of cells and tissues, which are necessary for obtaining such products at medical/surgical levels, or by the short shelf life of the final product.
Challenges for small batch manufacturing, rapid testing and analysis and storage are only some of the challenges for such short shelf life products in terms of:
- Comparability with Compendial Methods
- Sensitivity and Robustness
- Suitability
Target Audience
This conference is aimed at all persons who
- are involved in the extraction and manufacture of Cells, Tissues and ATMPs
- re responsible for microbiological or analytical testing
- perform inspections or audits of ATMPs facilities
- deal with the authorisation
Moderators
Dr Sabine Hauck, Chair of ECA ATMP Interest Group
Dr Ulrike Herbrand, Charles River Laboratories
Detailed Programme
Are you familiar with Aseptic Environment for ATMP Manufacture?
Dr Rainer Gnibl, Local Government of Upper Bavaria
- Qualification & environmental monitoring
- Legal duties
- GMP-inspector’s expectations
- Side glances on revised Annex 1
Points to be considered by ATMP Developers when deciding for a GMP-compliant Mycoplasma Detection Assay
Dr Sabine Hahnau-Jurth, bioMérieux
- Mycoplasma – Basics and Relevance
- Detection and Testing Methods
- Regulatory Requirements
- BioFire FilmArray System and Protocols for CGT Applications
- Performance Studies and Matrix Suitability with CGT Preparations
- GMP Validation Strategy
QP Release of Cchallenging Products – ATMPs
Miriam Holohan, Center Cell Manufacturing Ireland
- Investigational Medicinal Products - Clinical Trial Legislation overview
- Advanced Therapy Medicinal Product (ATMP) Regenerative Medicine; The Galway, Ireland, Story!
- ATMPs a QP challenge; specific examples including: starting material variability, establishing QC specifications, Shipping; Cryopreserved vs Fresh product
- Guidance on actions to mitigate potential issues with release of ATMP cellular products
GMP-Compliant Manufacturing of Personalised Peptide Vaccines – Regulatory Demands and Practical Challenges
Julian Thimm, DKFZ Heidelberg
- Regulatory framework and GMP requirements for individualiszed peptide-based immunotherapies
- Implementation strategies: (our) best practices for aseptic production of personaliszed, small-batch peptides
- Specific manufacturing and QC challenges – and potential solutions
- Open technical and regulatory gaps: what remains unresolved?
- Discussion: sharing experiences, unanswered questions, and future perspectives
Increasing Process Flexibility and Quality in Filling Applications with high Accuracy Flow Meters
Fernando Rangel, SONOTEC
- Advantages and influences of non-contact high accuracy flow meters and air bubble detectors in upstream and downstream biopharmaceutical manufacturing
- Technical principle behind non-invasive ultrasonic flow measurement and air bubble detection
- Real-time CPP monitoring to ensure QbD strategies for constant high product quality avoiding any volume tolerances in, e.g., feeding, media & buffer management, as well as filling
- Application example: RoSS.FILL by Single Use Support
- Automated filling of multiple smaller and larger volumes between 1 mL and 1000 L into single-use bags or bioprocessing containers
- Filling accuracy range of even less than ± 1 mL
Bench to Market: Why early Market Access Planning is critical in Drug Development
Mag Dr Marie-Luise Gil, Gillhofer & Plank
Dr Wolfgang Tüchler, Axxess Healthcare Consulting
- Importance of early market access integration during drug development
- Literature review and case studies: success factors and common pitfalls in early access strategies
- Best practices for endpoint selection, study design, and differentiation strategies
- Role of PROs and real-world data in strengthening clinical and payer value
- Price modelling and competitive dynamics: early scenario planning
- Stakeholder engagement: collaboration with regulators, payers, KOLs and patient advocates
If the Guidelines become a Challenge
Kati Kebbel, Fraunhofer Institute for Cell Therapy und Immunology
- Media Growth Promotion Test according to EP 2.6.1 vs. 2.6.27 and impact to sterility method validation
- APS challenges
- Change of standard APS strategy - a future vision?
Specification by Design – Update for ATMPs
Dr Sabine Hauck, dequra pharma consult hauck
- European Guidance (EMA, Ph. Eur.)
- ICH Q6 and it's planned update
- Opportunities of patient centricity
ATMP Workflow Orchestration: From manual Complexity to one Digital Thread
Dr Dmitry Fridman, Miltenyi Biotec
- A single digital thread cuts through the complexity by linking teams, data, and instruments
- Streamlined, compliant workflows accelerate turnaround and scale with demand
- Electronic batch records through connected systems speed production and eliminate human error risk
Engineering Tomorrow’s Therapies Today: A GMP Hub for Biologics & ATMP Acceleration
Dr Michela Castellani-Kleinschroth, SKAN
- ATMP development in clinical stage
- Fast technology transfer with low risk
- Next-generation manufacturing & digital quality assurance
- End-to-end customer support