1773 Kings Road, Vista, CA 92084-3640, USA

Tel 1-760-941-2040 or 1-800-698-2040, Fax 1-760-301-0308, e-mail: info@cce-us.com

Course Content:

Product characteristics

• Physicochemical 

• Biological 

Product recovery

• from host cells 

• from spent nutrient 

Characteristics of key contaminants and strategies for their removal 

• Nutrient-derived contaminants

• Host Cell Protein

• DNA

• Endotoxin

• Viruses 

Operating principles and limitations of key recovery and purification methods

• Depth Filtration

• Cross-Flow Filtration

• Diafiltration

• Centrifugation

• Precipitation

• Size exclusion

• Ion exchange

• interaction

• Affinity

• Sterile filtration

• Nanofiltration

• Other methods 

Process development

• Method selection

• Matrix selection

• Development of separation conditions

• Capacity vs. separation performance

• Process optimization

• Lab-scale vs. manufacturing scale

Assuring proper performance of purification processes 

• Purification setup

• Protection of column life 

• Cleaning and sanitization methods

• Control of bioburden

• Predictors of column performance and on-stream life

Scale-up and scale-down

• Lab scale vs. production scale 

• Defining and meeting production-scale goals

• Guiding parameters for scaleup

• Technology transfer from lab to production floor 

Process validation

• Qualification of materials and components

• DQ, IQ, OQ and PQ of equipment 

• Cleaning and sanitization validation 

• Removal/Inactivation validation of key contaminants 

• Software validation