GMP for Advanced Therapy Medicinal Products (ATMP)

GMP for Advanced Therapy Medicinal Products (ATMP)

Berlin, Germany

Course No 16648


Costs

This conference already took place.

If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@gmp-compliance.org

Speakers

Dr Rainer Gnibl, Government of Upper Bavaria
Dr Andrea Hauser, Jose-Carreras Center, University Hospital Regensburg
Dr Hiltrud Horn, Horn Pharmaceutical Consulting
Jan-Oliver Karo, PEI, German Federal Institute for Vaccines and Biomedicines
Dr Matthias Renner, Paul-Ehrlich-Institut; German Federal Institute for Vaccines and Biomedicines
Niina Taylor, Pfizer

Objectives

Relating to the fact of the new GMP Guidelines on GMP requirements for ATMP and the ongoing scientific developments, this Workshop aims to provide an insight view in the regulatory requirements on ATMP with a focus on GMP aspects. During development as well as during manufacturing of Advanced Therapy Medicinal Products for clinical trials and on industrial level. Representatives from authority, consulting as well as from science and manufacturers will share their experiences with you and give you the possibility to discuss intensively the special challenges for ATMPs.

Background

Advanced therapy medicinal products (ATMP) are a 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 academic/medical roots of these SME implicates generally special challenges to stay in compliance with regulatory requirements on marketing authorization and GMP. Especially open manipulations of cells and tissues on medical level necessitate adapted procedures.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.

Target Group

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 on 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

Programme

Tissues, Tissue Preparations and ATMPs: 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
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
Regulatory and Practical Aspects for ATMPs - requirements for QPs
  • Starting materials for ATMPs
  • Raw/ancillary materials for production
  • Specifics for process validation and quality control of ATMPs
  • Responsibilities of the QP - what is different for ATMPs
Requirements on Manufacturing of Cell-based products under GMP
  • Important Aspects for Characterisation and Control
  • Quality of Reagents and Materials
  • Relevant guidance documents
  • Inspection Experiences and Findings
  • Common Deficiencies in Clinical Trial Applications
Case Study – Manufacture of an ATMP for a phase I/II clinical trial in an academic setting
  • Installation of a clean room facility for manufacture of ATMPs in an academic setting
  • Establishment and validation of the manufacturing process with special focus on GMP-compliant FACS sorting
  • Application for a phase I/II investigator initiated clinical trial
GMP Implementation - Practical Industrial Experiences
  • Challenges in aseptic manufacturing
  • Dealing with research grade raw materials in a cGMP environment
  • Dealing with Contract Manufacturing organisations
  • Specific cGMP challenges and possible solutions
Microbiological Safety of ATMPs
  • Challenges and Critical Aspects
  • Relevant Guidance Documents
  • Modern Microbiological Safety Concepts
  • Case Studies from Microbiological Assessment

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