Language selection: Pharma Kongress - Switch to the German version of the website DE | Pharma Congress - English version of the website EN

ECA - Current Aseptic Technologies & Compliance - Live Online

 

Current Aseptic Technologies (15 September 2020)

Objectives

Reasons to attend this conference:

  • You will be informed on new technological developments in sterile / aseptic manufacturing
  • You will learn how current GMP and production requirements have to be implemented technologically
    in sterile manufacturing
  • You will get case studies from pharmaceutical companies
  • Live Demos will show you how technologies perform

Background

GMP regulations only define general requirements for equipment – it has to be suitable for the intended work process, easy to clean and without any negative infl uence on the product quality. Questions like how these general requirements have to be fulfilled concretely in sterile manufacture, which points call for special attention and which new technologies will be used in the future are in this conference’s focus. Speakers from the pharmaceutical industry and from planning and engineering companies deal with pivotal developments in the fi eld of sterile manufacturing.

Moderator

Gert Moelgaard, ECA Validation Interest Group
Jörg Zimmermann, Vetter Pharma-Fertigung

Target Audience

The event is directed at specialists from the pharmaceutical industry as well as at engineers and planners who have to deal with current aseptic technologies in clean areas in their daily practice. It particularly addresses the departments:

  • Production
  • Quality assurance
  • Engineering / Technology

 

Programme

CONGRESS KEYNOTE

Annex 1 Revision – the long and winding road
Dr. Bernd Renger, Immediate Past Chair, European Qualified Person AssociationThe drivers of change

  • New paradigms and concepts
  • Contamination Control und Quality Risk Management
  • Stakeholder consultation
  • New expectations to Media Fills and Lyophilisation
  • The big challenges – CCIT and PUPSIT

 

Technological overview: Single-use technologies for intensi ed and continuous bioprocesses (USP & DSP)
Prof. Dr. Regine Eibl, Zürcher University of Applied Science

  • Continuous USP
    − High cell density and large volume cell banks
    − N-1 perfusion
    − Production in perfusion mode
    − Clarifi cation
  • Continuous DSP
    − Bind-elute chromatography
    − Virus inactivation
    − Flow-through chromatography
    − Virus filtration
    − Final ultra- and diafiltration

Continuous Biomanufacturing - a GMP inspector's view
Dr. Daniel Müller, Local GMP Authority of Baden-Württemberg

  • Regulatory guidance
  • General requirements
  • Application of single-use systems
  • Control & validation strategy
  • Challenges and discussion points

Case Study Bayer: Continuous Downstream Processing for manufacturing of protein therapeutics
Dr. Felix Oehme, Bayer

  • Challenges and benefi ts of continuous manufacturing for biologics
  • Case study: Comparison of process parameters and product quality in batch and continuous manufacturing
  • Control strategy and regulatory aspects

Challenges in manufacturing high value lyophilized oncologics - a case study
Fabio Gentilini, BSP Pharmaceuticals

  • BSP’s requirements for a flexible CMO sterile suite with space constrains for high value oncological products containing solvents under isolation technology
  • Suppliers provided solutions including:
    • Reduced foot-print equipment
    • Innovative loading/unloading system (including cold shelf loading)
    • PAT tools (including nucleation)

Case Study: Cycle Development & Validation of automated AHP decontamination processes for cleanrooms
Dr Markus Lesch, Vetter Pharma-Fertigung

  • Design of decontamination system & cleanroom
  • Optimization of aerosolized amount of H2O2
  • Selection of positions to be challenged with indicators
  • Optimization of relative humidity
  • Optimization of decontamination time
  • Value of chemical indicators for validation of AHP processes

EirGen Pharma – How state-of-the-art fill & finish equipment flexibility supports CMO business
Dermot O'Riordan, EirGen

  • Possibilities and challenges when processing various RTU packaging components
  • Challenges of filling non- to high-potent products
  • Flexibility in aseptic filling processes
  • Challenges of manufacturing different products with different batch sizes

 

Current Aseptic Compliance (16 September 2020)

Objectives

Reasons to attend this conference:

  • You will be informed on the current status of EU Annex 1 revision
  • You will learn how current GMP and production requirements have to be implemented in sterile manufacture
  • You will get case studies from pharmaceutical companies

Background

EU GMP Annex 1 on sterile medicinal products is currently under revision. A first public draft from 2017 was intensively discussed. What are the consequences of this discussion and what are the next steps to a final document will be explained in this conference.

Moderator

Gert Moelgaard, ECA Validation Interest Group
Jörg Zimmermann, Vetter Pharma-Fertigung

Target Audience

The event is directed at specialists from the pharmaceutical industry as well as at engineers and planners who have to deal with current aseptic regulations in their daily practice. It particularly addresses the departments:

  • Production
  • Quality assurance
  • Engineering / Technology

 

Programme

CONGRESS KEYNOTE

Case Study AbbVie: The new Biologics Site in Singapore
Dr. Rolf Ratke, Abbvie
Ronan Mc Garvey, Abbvie

  • The Site strategy
  • Products, processes & equipment
  • Cooperation with EMA, blueprint to prepare for the successful pre-approval-inspection
  • From start- up to realization until approval

 

Case Study: Media Fill Design for aseptic Blow Fill Seal Filling
Dr. Martin Haerer, Rommelag CMO

  • General Media fill concept
  • Bracketing concept
  • Intervention procedure
  • Operator involvement
  • Evaluation

Environmental Monitoring in Modern Biopharmaceutical DP Facilities – A Proposal for a Harmonized Risk Based Approach for Selecting Monitoring Points and Defining Monitoring Plans
Patrice Wery, GSK Vaccines

  • What about Biophorum, the group working on this Risk Assessment?
  • Why do we need a harmonized Risk Assessment tool?
  • Explanation of the tool in a step by step approach
  • First feed-back of authorities
  • A practical example to illustrate how it works

Status of Annex 1 revision?
Dr. Rainer Gnibl, Government of Upper Bavaria

Single Use Bioreactor Platform(SUB)  for Microbial Fermentation in a GMP manufacturing facility
Dr. Sofia Venceslau, Genibet

  • Benefits for GMP production
  • Broaden the use of SUBs to expand bacteria and yeast cells
  • Main faced challenges

Challenges and Opportunities of Aseptic Manufacturing Process Transfers
Dr. Martin Schwab, Vetter Pharma-Fertigung

  • Manufacturing Process Transfers / Clean Room Transfers: Background, Drivers, Characteristics
  • Technology Transfer: Like for like, process optimization, gap- and risk-analysis, challenges
  • Lessons learned and outlook

Areas of focus for Auditors of Sterile Operations
Hesham Elrayes, B.Braun

  • Areas to be focused
    • APRs (PQRs)...
    • BRs
    • Deviations/InvestigationsTraining
    • Complaints
    • Adverse Events – Signal Detection
  • What should I spend some time looking at here...?
    • Batches Manufactured
    • Analytical Data & Trend Analysis
    • Qualification status of equipment
    • Quality Agreements
    • Sterilization cycles
    • Environmental Monitoring
  • Assessment tools to focus on key process and environmental elements relative to audit aseptic Lyophilization process