ATMPs - Hurdles & Achievements in Quality and Safety
Objectives
Background
Modern systems of regenerative medicines, 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. With the entry into force several regulatory guidelines e.g. of the European Directive EC 1394/2007 for ATMPs, such products were classified as medicinal products and must therefore comply as such with the EU requirements for medicinal products. Although the biopharmaceutical industry has considerably intensified its activities in this field, many of these products are 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 forced by frequently given manufacturing conditions, e.g. the open manipulation of cells and tissues, which are necessary for obtaining such products on a medical/surgical level or by the short shelf life of the obtained 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 Testing and Validation
- Variability
Target Group
This conference is aimed at all persons who
- are involved in the extraction and manufacture of Cells, Tissues and ATMPs
- are responsible for quality assurance and control of Cells, Tissues and ATMPs
- are responsible for microbiological or analytical testing
- perform inspections or audits of ATMPs facilities
- deal with the authorisation
Programme
Seminar Programme as PDF
Lessons learned from EMA Filling for TEMP
Dr Katja Aschermann, Tetec
Quality Assurance of mRNA Vaccines for Human Use: The Role of the European Pharmacopoeia
Prof Dr Gerit Borchard, University in Geneva & member of the EDQM expert group
Industrial Scale in Vitro Expression of Bacteriophages and other Proteins
Patrick Grossmann, Invitris
Viral Clearance
Sandra Zucchet, CRL
Visible and Subvisible Particle Control for Cell Therapy From Development to Commercialisation
Dr Roman Mathaes, Clear Solutions Laboratories
Flexibility and Redundancy in Visual Inspection Production Planning with Small-Scale Systems
Alexander Schäfer, Wilco
Gloveless aseptic Fillers for small Batches and Cell & Gene Therapy Sectors: a novel Approach utilizing modular Design and magnetic Levitation Conveyors
Giacomo Guidi, IMA Life
Process Validation Sterile Drug Products: Strategy, Execution and maintaining the validated State
Dr Anne Orillo, Novartis Pharma
Challenges on the Way to becoming a Contract Manufacturer
Dr Carolin Klemm, DKMS Stem Cells
Simone Sonnenberg, DKMS Stem Cells Vector Safety Assessment in Cell and Gene Therapy by NGS/TGS Sequencing
Dr Richard Gabriel, ProtaGene
Challenges and Special Requirements for GMP Inspections of ATMPs
Alexander Kammerlocher, Regierungspräsidium Tübingen (local competent authority)
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Seminar Programme as PDF
