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Program Overview

The risk of adventitious viral and pathogen contamination is highly relevant to most of all biotechnology products derived from cell lines of human or animal origin as well as plasma/plasma-derived medicinal products. Such contamination event could possibly elicit serious consequences including risk to patients, shortage of product supply and the substantialities of the business. Therefore, it is expected the viral safety of medicinal products shall be reasonably assured through the application of a rigorius testing and control program and robust assessment of virus removal and inactivation achieved through the manufacturing and purification process. And based upon the first three years' program, through collaborating with International Serum Industry Association and leading KOLs, the PCA2017 forum aims to build up and facilitate the progressive regulatory, scientific and technical communication to advocate the Safety and Quality profiles of bio-therapeutics in the region.


2017 Speaker Committee

  • Yuling Li

    Director, Biopharmaceuticals Development
    MedImmune, AstraZeneca
  • Shawn Liu

    Chief Scientist, Head of Pathogen Safety, Global Biological Development
    Bayer Healthcare Pharmaceuticals
  • Albrecht Gröner

    PathoGuard Consult
  • Thomas Kreil

    Senior Director, Global Pathogen Safety
  • James Leung

    Senior Research Fellow, Center for Biomedical Innovation
    Massachusetts Institute of Technology
  • Nathan Roth

    Senior Director, Head Global Pathogen Safety
    CSL Behring
  • Prof. Thierry Burnouf

    Director, Graduate Institute of Biomedical Materials and Tissue Engineering
    International PhD Program in Biomedical Engineering & Translational Therapies College of Biomedical Engineering, Taipei Medical University
  • Horst Ruppach

    Director, Viral Clearance
    Charles River Laboratories

Program Key Discussions

Current Regulatory Perspectives and Requirements on Virus and Pathogen Safety
Intergrated Viral/Pathogen Safety Strategies for the Recombinant, Advanced Products and Vaccines
Viral Safety and Clearance Development for Plasma/Plasma-derived Medicinal Products
Raw/Starting Materials Risk Assessment and Characterization
Viral Contamination Risk Mitigation for the Cell Culture-based Manufacturing
Risk and Regulatory Considerations to Implement the Novel Cell Substrates
The Selection of Virus for the Evaluation and Characterization of Viral Clearance
Preparation and Quality Control of Virus Spike
Adventitious Agent Detection and Emerging Viruses
Quality by Design Approach for Viral Safety
The State of the Art for Virus Filtration
MoA of Virus Removal, Inactivation and Verification of the Scaled-down Model
Phase Forward Viral Clearance Strategies
Issues and Strategies with HEV, PCV, TSE and Mycoplasma Contamination


Who should Attend

More than 120 Participants are expected to attend 'Pathogen Clean Asia Summit 2017',  The participants will mainly come from the Biotechnology Corporate, Blood Products Manufacturers, Regulatory Agencies, Contract Testing/Research Organizations, Contract Manufacturing Organizations, Cutting-edge Purification and Filtration Systems with the main responsibilities including but not limited to:

Process Development and R&D
Downstream Purification and Viral Validation
Quality Assurance and Management
Viral/Pathogen Safety Assessment
Regulatory and Scientific Review