The Waterside Conference


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  • Exhibits:
  • Media Partners:

Advances in Bioprocess Development

Chaired By:

Swapnil Bhargava, PhD
Seattle Genetics, Inc.
Daisie Ogawa
Boehringer Ingelheim Corporation

Topics

  • Cloning and Performance Optimization
  • Media and Buffer Development
  • Single-Use Systems and Components
  • Closed Systems
  • Robotics
  • Perfusion, Fed Batch, Batch Processes
  • Feed and Harvest Strategies
  • Managing Metabolites and Dissolved Gases
  • In-Line, At-Line, Off-Line Analysis
  • Continuous Processing
  • Integrating Unit Operations
  • Defining Lots and Release Testing

Contaminant Control

Chaired By:

Jeri Ann Boose, PhD
Eurofins Lancaster Laboratories, Inc.
Raymond Nims, PhD
RMC Pharmaceutical Solutions, Inc.

Topics

  • Host Cell Proteins
  • Host Cell DNA
  • Sterility and Endotoxins
  • Mycoplasma
  • Viral Contaminants and Clearance
  • Rapid Microbial Testing
  • Regulatory Expectations
  • Particulates

Cell Banking & Characterization

Chaired By:

Fang Tian, PhD
American Type Culture Collection (ATCC)
Linda Roth, PhD
AstraZeneca R&D
Haruhiko Murata, MD, PhD
FDA CBER

Topics

  • Cell and Tissue Procurement
  • Cell Line History and Authentication
  • Regulation and Governance
  • Cold Chain Management
  • Cell Bank Management
  • Stability and Characterization
  • Contaminant Identification and Clearance
  • Cryopreservation
  • Cell Line Development

Raw Materials Science & Control

Chaired By:

David Kolwyck
Biogen
Kevin P. Kent, PhD
Boehringer Ingelheim Animal Health

Topics

  • Analytical Technologies for Raw Material Characterization
  • Raw Material Qualification
  • In-House Testing vs. Vendor CoA
  • Tech Transfer
  • Leveraging CDMO for Speed to Clinic
  • Vendor Qualification
  • Product Comparability
  • Use of Standards
  • Purity and Consistency
  • Acceptance Testing
  • Storage and Release Testing
  • Expired Materials