Plant flexibility

• Market factors– Flexibility to produce

alternative products– Produce multiple products

simultaneously

• Societal trends– Utilization of disposable

equipment

Plant flexibility

• Auxiliary downstream equipment– Redundant depth filtration– Redundant ultrafiltration

cassette holders

• Separate rooms– Redundant seed train

room– Bioreactors room dividers

Good manufacturing practices

• Provide for proper flow

• Uncontaminated raw materials

• Segregated activities

• Cleanable surfaces

• Minimization of equipment density

Good manufacturing practices• Our solutions:

Problem RemedyCross-contamination

Unidirectional personnel flowSegregated activities

Contaminated raw materials Water for injection system• Vapor compression distillation• Falling film clean steam generation

Surface contamination

Stainless steel constructionMinimization of equipment density

Pure product recovery