Quality, Safety and GMP for Advanced Therapy Medicinal Products (ATMPs)
Im Auftrag der ECA Academy

Quality, Safety and GMP for Advanced Therapy Medicinal Products (ATMPs) Im Auftrag der ECA Academy

Neuss, Germany

Seminar Nr. 17555

 

Kosten

ECA-Member: EUR 1590,--
Non ECA Member: EUR 1790,--
EU/GMP Inspectorates: EUR 895,--
APIC Member Discount: EUR 1690,--

Alle Preise zzgl. MwSt.

Rückfragen unter:
Tel.: 06221 / 84 44 0 E-Mail: info@concept-heidelberg.de

Sprecher

Dr Anette Jork, BioNTech
Dr Ilona Kalaszczyńska, Medical University of Warsaw
Dr Thomas Meindl, Labor LS
Dr Christoph Peter, BioNTech
Dr Christoph Prinz, Apceth
Dr Christianne Reijnders, The Dutch Health and Youth Care Inspectorate 
Dr Ralf Sanzenbacher, PEI, German Federal Agency for Vaccines and Biomedicines
Mag. Gabriela Schallmeiner, Inspection Ready
Prof. Michael Schmitt,  University Hospital Heidelberg
Dr Jan Schrooten, Antleron
Dr Astrid Schwantes, PEI, German Federal Agency for Vaccines and Biomedicines

Zielsetzung

This workshop provides a comprehensive overview of the current regulatory requirements for the development, manufacture and approval of Advanced Therapy Medicinal Products (ATMP). Representatives of regulatory authorities, experts from small-scale and large-scale production, QC laboratories and consultants will report on their practical experiences. From the construction of a new production facility to the introduction of a quality system and the final sterility test, all relevant topics directly related to ATMPs will be covered.

Hintergrund

Modern systems of regenerative medicines, especially ATMPs (gene therapeutics, somatic cell-based products and tissue-based products) represent an innovative group of drugs that is becoming increasingly important. With the introduction of several regulatory guidelines e.g. of the European Directive EC 1394/2007 for ATMP, 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 companies. These university or medical origins result in 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 underlined by commonly occurring operating 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.

This results in a whole range of extraordinary requirements:
  •  the consideration of later requirements during development and in clinical phases
  •  the implementation of quality assurance requirements during aseptic production
  •  the use of alternative methods for analysis and microbiological control and the demonstration of comparability with conventional methods
  •  the handling of out of specification (OOS) / and out of limit (OOL) results during product testing and the possibility of batch release
     

Zielgruppe

This seminar is aimed at all persons who
  •  Are involved in basic or translational research on cell-based therapy concepts with the perspective of clinical application
  •  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 ATMP facilities
  •  Are responsible for GMP requirements during pre-approval phases
  •  Deal with authorisation

GMP/GDP Certification Scheme

Building on your education the ECA GMP/GDP certification programmes provide you with the appropriate supplement to acquire this qualification. Simply choose any three courses within the programme according to your professional interest. Your certificate is then valid for two years. To renew it, you can pick any training from the ECA courses and conferences list within that two-years period – allowing you to broaden your knowledge in GMP and GDP compliance.

Programm

Regulatory Development
  •  New and revised  guidelines
  •  Other relevant documents
  •  Current experiences and expectations
Challenges for Cell-Based Medicinal Products
  •  How to increase stability of cell-based medicinal products
  •  Can growth medium influence properties of cell-based medicinal product
Risk-based Approach and Evaluation is the Leading Tool towards Manufacturing Authorization for iATMPs
  •  European GMP guideline Part IV: GMP for ATMPs
  • Gaining flexibility by professional risk reduction
  •  Time to manufacturing authorization
Cell by Design®, a Quality-Focused Process Development Roadmap for ATMPs
  •  Software for risk-based ATMP process development and data driven decision making
  •  Quality by design principles coupled to ATMP legislations, standards and guidelines
  •  Master quality, manufacturability and scalability of ATMP product and process
  •  Enable QC cost-effectiveness by parametric release
A Case Study  - Optimizing Manufacturing
  •  Patient individualized cancer treatment using targeted RNAs
  •  The challenges of patient individualized medicines
  •  The challenge of small batches in combination with large batch numbers
  •  How to establish high throughput manufacturing - dos and don’ts
In-house Production of CAR-T Cells

ATMP Challenges for a QP
  •  A glimpse on the legal framework
  •  The complexity
  •  ATMP specific challenges
  •  What you should know about working with a QP
ATMP GMP Inspection Experiences
  •  Findings
  •  Pitfalls
  •  Hospital exemption
Strategies for validating nucleic acid-based techniques for testing for the absence of Mycoplasma
  •  NAT Techniques
  •  Strategies for validation/suitability tests
  •  Pitfalls and practical examples
Virus Safety Concepts for ATMPs
  • Safety of raw and starting materials
  •  Serum and serum replacement(s) for cell-based products
  •  Testing methodologies (NGS)
  •  Virus inactivation and removal
Process Optimization for Individualized ATMPs - a Modern Approach
  •  Aseptic filling for small batches
  •  Hygiene monitoring in closed Isolators required?
  •  Regulatory challenges
Treating Patients with OOS Batches - when Physicians Request Non-Conforming ATMPs
  •  Regulatory framework
  •  Perspective and expectations from patients, physicians, sponsors, manufacturers, QPs, authorities - EU vs. US
  •  Batch control, review and release process

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