GMP for Advanced Therapy Medicinal Products
Im Auftrag deer ECA Academy

GMP for Advanced Therapy Medicinal Products Im Auftrag deer ECA Academy

Vienna, Austria

Seminar Nr. 17007


Kosten

Non ECA Member: EUR 1790,--
ECA-Member: EUR 1590,--
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 Iris Bürger, Miltenyi Biotec
Marco Fadda, Comecer
Dr Markus Fido, VelaLabs
Carolin Fromm, Labor LS
Dr Rainer Gnib, Gouvernment Upper Bavaria
Dr Hiltrud Horn, Horn Pharmaceutical Consulting
Dr Christoph Prinz, Apceth
Dr Antonio Rodríguez Acosta, Andalusian Initiative for Advanced Therapies, Malaga
Dr Ralf Sanzenbacher, Paul-Ehrlich-Institut, German Federal Agency for Vaccines and Biomedicines

Zielsetzung

This course 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, the relevant topics directly related to ATMP will be covered.

Hintergrund

Advanced therapy medicinal products (ATMP) are an emerging class of innovative biopharmaceutical medicines, summarizing gene therapy, somatic cell therapy and tissue-engineered products. With the adoption of the ATMP regulation EC 1394/2007, ATMPs are regarded as medicinal products and must consequently comply with current EU drug legislation including GMP. Although pharma industry recently increased their activities to this new area , but the development of these complex products is still focused at universities, hospitals and spin off companies derived thereof (small medium enterprises, SME). This implicates special challenges for compliance these SME with regulatory requirements on marketing authorization and  GMP. With the publishing of the new stand-alone guidance document on the GMP requirements in November 2017, EMA tried to define the expected standards for this special kind of medicinal products.

Zielgruppe

This course is advisable to people who
  • Are involved in basic or translational research on  cell-based therapy concepts with the perspective of clinical application
  • Are responsible for quality aspects on ATMP
  • Implement GMP in ATMP manufacturing
  • Are involved in regulatory inspections of  ATMP
  • Are responsible for GMP requirements during pre-approval phases

Programm

Regulatory Expectations on Tissues, Tissue Preparations and ATMPs – an Introduction
  • Overview on Products and Therapies: Reality and Future
  • Legal Framework in EU and Germany
  • CTA, Hospital Exemption and Marketing Authorisation: Steps to Consider in the Development of ATMPs
Quality Aspects of ATMP – Practical Experiences from a CMO’s point of view
  • Complexity of ATMPs and good Technology Transfer
  • Quality Assessment on Cell Products after Non-Conformances
  • The role of the QP
Requirements on Manufacturing of Cell-based products and Inspection Experiences
  • Important Aspects for Characterisation and Control
  • Quality of Reagents and Materials
  • Relevant guidance documents
  • Inspection Experiences and Findings
  • Common Deficiencies in Clinical Trial Applications
Quality and manufacturing aspects of CAR-T-Cells

Microbiological Safety of Advanced Therapy Medicinal Products
  • Aseptic manufacturing of ATMPs according new Guidelines on Good Manufacturing Practice specific to Advanced Therapy Medicinal Products.
  • How to apply the Ph. Eur. 2.6.27 Microbial examination of cell-based preparations using Automated Growth-Based Methods, Method suitability studies and results.
  • Microbiological security of ATMPs. A review of the main sources of microbial contamination: from starting and raw materials to finished products.
  • The big challenge of the future: Viral security of allogeneic ATMPs. The immunosuppressed hosts factor and viral reactivation.
Sterility Testing of ATMP
  • Challenges of sterility testing of ATMPs
  • Matrix-specific selection of a rapid method for sterility testing
  • Time to result / negative-to-date results
  • Analytical characterization of ATMPs according to EMA expectations
  • Requirements and categorization for ATMPs
  • Examples and analytical designs for selected drugs
  • Developing and control under GL(C)P & GMP
  • Products on the market – description and characterization
The New EU-GMP Guideline for ATMP (Part I)
  • Guideline Overview
  • ATMPs & Quality Risk Management
  • Zone Concept for ATMP-Facility
  • Focus: Qualification & Monitoring
The New EU-GMP Guideline for ATMP (Part II)
  • Focus: Process-Validation & Media Fill
  • Focus: Documentation
  • How to certify/release an ATMP Batch
  • Specific Products/Processes
GMP for ATMP – Considerations to European and US Requirements from industrial point of view
  • Essential Effects of the New Guideline
  • Challenges in Practice
  • US Requirements
Development and implementation of a large scale GMP production plant for EMA – approved ATMP cartilage substitute
  • Scaling-up ATMP production does not involve only dimensional considerations
  • A correct management of production complexity reflects on the overall process quality
  • Hardware and Software innovative approaches are fundamental for a successful and cGMP compliant outcome

Zurück

GMP Seminare nach Thema

Cookies helfen uns bei der Bereitstellung unserer Dienste. Durch die Nutzung unserer Dienste erklären Sie sich damit einverstanden, dass wir Cookies setzen. Weitere Informationen

OK