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• Cell and Tissue
   Procurement
• Establish a Cell Line
• Cell Line History and
   Authentication
• Informed Consent / Legal
   Issues
• Cold Chain Management
• Cell Bank Management
• Stability and
   Characterization
• Contaminant Identification
   and Clearance
• Cryopreservation

PROGRAM CHAIRS:
Alissa M. Resch, PhD
Coriell Institute for Medical Research
Fang Tian, PhD
American Type Culture Collection (ATCC)
• Raw Material Qualification
• In-House Testing vs.
   Vendor CoA
• Change Control
• Tech Transfer
• Managing CDMO
   Relationships
• Vendor Qualification
• Product Comparability
• Use of Standards
• Purity and Consistency
• Acceptance Testing
• Storage and Release
   Testing
• Expired Materials
• 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
• Host Cell Proteins
• DNA and Endotoxins
• Sterility and Mycoplasma
• Viral Contaminants and
   Clearance
• Rapid Sterility Testing
• Product Purity and
   Potency
• Cell-Based Assays
• Regulatory Expectations

PROGRAM CHAIRS:
Jeri Ann Boose, PhD
Eurofins Lancaster Laboratories, Inc.
Raymond Nims, PhD
RMC Pharmaceutical Solutions, Inc.
• Clarification
• High Initial Concentrations
• Resin Structures and
   Chemistries
• Purification Platforms
• Regeneration and
   Sanitization
• In-Line, At-Line, Off-Line
   Analysis
• Product Yield and Purity
• Viral Clearance
• Continuous Processing
• In-Line Dilution
• Extractables and
   Leachables
• Aggregation
• Choice of Final Container




International Society for BioProcess Technology
110 Willow Grove Ct., Norfolk, Virginia 23505 USA • Phone: 757.467.8903, Fax: 757.257.3800
Web: www.isbiotech.org • Email: info@isbiotech.org